Scientists have discovered a previously unknown mechanism by which apolipoprotein E, a molecule whose mutation is linked to Alzheimer's disease (AD), stimulates degradation of sticky amyloid beta (A) protein within the brain. The research, published by Cell Press in the June 12 issue of the journal Neuron, may lead to a powerful new therapy for this devastating disease.
One of the primary characteristics of AD is the accumulation and deposition of neuron-damaging clumps of A protein. Apolipoprotein E (ApoE), a cholesterol transport protein, is known to be a key regulator of brain A levels, and it is likely that processes that regulate ApoE activity will influence A deposition and clearance. "An isoform of ApoE, ApoE4, has been shown to confer dramatically increased risk for late-onset AD; however, the basis for this remains one of the major unanswered questions of disease pathogenesis," writes study author Dr. Gary E. Landreth from the Alzheimer Research Laboratory at Case Western Reserve University School of Medicine in Cleveland, Ohio.
Dr. Landreth and colleagues sought to unravel the link between ApoE, A clearance in the brain, and an enhanced risk for AD. The researchers found that ApoE profoundly enhanced the intracellular and extracellular degradation of A?. This enhancement varied for different isoforms of ApoE with the ApoE4 isoform exhibiting an impaired ability to promote A degradation when compared to other ApoE isoforms. The number of lipid molecules associated with ApoE was also critical to its ability to stimulate A degradation. Activation of liver X receptors (LXRs) to enhance expression of lipidated ApoE significantly facilitated A degradation. Importantly, use of an LXR agonist to increase lipidated forms of ApoE in a mouse model of AD resulted in reduced A? plaque levels and an improvement in contextual memory.
The results of this study document a major role for ApoE in the stimulation of A degradation within the brain and highlight the importance of lipidation to the function of ApoE. This work also explains the previous observation that inactivation of a gene which helps the brain to process lipids (called Abca1) resulted in decreased levels of ApoE along with a seemingly paradoxical elevation of A levels and plaque formation in mice. "Our data suggest that therapeutic agents that increase the levels of lipidated forms of ApoE, including LXR agonists, represent a potentially efficacious therapy for AD," concludes Dr. Landreth.
The researchers include Qingguang Jiang, Case Western Reserve University School of Medicine, Cleveland, OH; C.Y. Daniel Lee, Case Western Reserve University School of Medicine, Cleveland, OH; Shweta Mandrekar, Case Western Reserve University School of Medicine, Cleveland, OH; Brandy Wilkinson, Case Western Reserve University School of Medicine, Cleveland, OH; Paige Cramer, Case Western Reserve University School of Medicine, Cleveland, OH; Noam Zelcer, Howard Hughes Medical Institute, University of California, Los Angeles, Los Angeles, CA; Karen Mann, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, OH; Bruce Lamb, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, OH; Timothy M. Willson, GlaxoSmithKline, Discovery Research, Research Triangle Park, NC; Jon L. Collins, GlaxoSmithKline, Discovery Research, Research Triangle Park, NC; Jill C. Richardson, GlaxoSmithKline, New Frontiers Science Park, Harlow, UK; Jonathan D. Smith, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, OH; Thomas A. Comery, Wyeth Research, Princeton, NJ; David Riddell, Wyeth Research, Princeton, NJ ; David M. Holtzman, Washington University School of Medicine, St. Louis, MO; Peter Tontonoz, Howard Hughes Medical Institute, University of California, Los Angeles, Los Angeles, CA; and Gary E. Landreth, Case Western Reserve University School of Medicine, Cleveland, OH.
Source: Cathleen Genova
Cell Press
вторник, 30 августа 2011 г.
суббота, 27 августа 2011 г.
Why Alzheimer's Disease Kills Some Neuron Types First
Bioengineers from the University of California, San Diego developed an explanation for why some types of neurons die sooner than others in the brains of people with Alzheimer's disease. These insights, published in the journal Nature Biotechnology, come from detailed models of brain energy metabolism developed in the Department of Bioengineering at the UC San Diego Jacobs School of Engineering.
The Alzheimer's insights demonstrate how fundamental insights on human metabolism can be gleaned from computer models that incorporate large genomic and proteomic data sets with information from biochemical studies. UC San Diego bioengineering professor Bernhard Palsson and his students and collaborators first developed this "in silico" modeling approach for E. coli and other prokaryotes, and later extended it to human tissues.
The Nature Biotechnology paper describes the first time this modeling approach has been used to capture how the metabolism of specific human cell types affect the metabolism of other cell types.
"In human tissues, different cells have different roles. We're trying to predict how the behavior of one cell type will affect the behavior of other cell types," said Nathan Lewis, a Ph.D. candidate in the Department of Bioengineering at the UC San Diego Jacobs School of Engineering and the first author on the Nature Biotechnology paper, which also includes authors from the University of Heidelberg, Massachusetts Institute of Technology, and the German Cancer Research Center (DKFZ).
Similar approaches can be used to identify potential off-target effects of drugs, provide insights on disease progression, and offer new tools for uncovering the underlying biological mechanisms in a wide range of human tissues and cell types.
Why Some Neurons Die First in the Alzheimer's Brain
In the brains of people with Alzheimer's disease, certain cells, such as glutamatergic and cholinergic neurons, tend to die in much larger numbers in moderate stages of Alzheimer's disease, while GABAergic neurons are relatively unaffected until later stages of the disease.
"There is a big question as to what is causing this cell-type specificity," said Lewis.
The researchers built Palsson Lab: Systems Biology Research Group computational models that captured the metabolic interactions between each of the three neuron types and their associated astrocyte cells. Next, the bioengineersknocked down ?±-ketoglutarate, a gene known to be damaged in patients with Alzheimer's disease, and let their models of brain metabolism run to see what happens.
The results from the models agreed with clinical data. When the bioengineers disrupted the ?±-ketoglutarate enzyme in the models for cholinergic and glutamatergic neurons, the metabolic rate of these neurons dropped, leading to cell death. "But then you have the GABAergic neurons that show no effect. So the cell types that are known to be lost early on in Alzheimer's show slowed metabolic rates," explained Lewis.
Analysis of their models then led the bioengineers to the biochemical pathways that allowed the GABAergic neurons to be relatively unaffected despite the disrupted gene.
"We looked at what upstream is allowing this and found a GABA-specific enzyme called glutamate decarboxylase," said Lewis.
When the researchers added this enzyme to the models of the other neuron types, the metabolic rates of these neurons improved as well. Thus the model allowed the researchers to identify a gene and how it contributes to the whole cell to potentially prolong the life of certain cells in Alzheimer's disease.
Large Scale Modeling of Metabolic Interactions
The new Nature Biotechnology paper uses the Alzheimer's brain study as an example of how to build models of metabolism that go one level deeper than previous work by taking into account the tissue microenvironment and metabolic interactions between specific cell types.
The models for each cell can be represented like a circuit, with certain inputs and outputs. For example, sugars, like glucose, are inputs, and the models detail how these inputs are used to build cell parts and secrete byproducts as outputs. The metabolic models the bioengineers built provide a means to study these networks.
For example, each cell type has different biochemical pathways that can take the sugars from point A to B. If you knock out a gene in between, the network might find a different route, produce different products, or predict cell death. When models for multiple cells are combined, additional insight can be gained since the inputs and outputs of each model begin to affect the other cells.
"There are many potential applications for these models. For example, this modeling approach could be useful for predicting off target side effects of drugs. You could theoretically take a cell line, throw a drug at it and see which metabolic pathways are significantly affected. Thus, you could decrease the amount of resources spent on drug development if the model suggests negative side effects that may cause it to fail," said Lewis.
Notes:
"Large-scale in silico modeling of metabolic interactions between cell types in the human brain," by Nathan E Lewis (1), Gunnar Schramm (2,5), Aarash Bordbar (1), Jan Schellenberger (3), Michael P Andersen (1), Jeffrey K Cheng (1), Nilam Patel (1), Alex Yee (1), Randall A Lewis (4), Roland Eils (2,5), Rainer K?¶nig (2,5) & Bernhard ?? Palsson (1); published online on November 21, 2010 in Nature Biotechnology.
(1) Department of Bioengineering, University of California, San Diego, La Jolla, California, USA.
(2) Department of Bioinformatics and Functional Genomics, Institute of Pharmacy and Molecular Biotechnology and Bioquant, University of Heidelberg, Heidelberg, Germany.
(3) Bioinformatics Program, University of California, San Diego, La Jolla, California, USA.
(4) Department of Economics, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
(5) Department of Theoretical Bioinformatics, German Cancer Research Center (DKFZ), Heidelberg, Germany.
This work was funded in part by a Fulbright fellowship, a National Science Foundation IGERT Plant Systems Biology training grant (no. DGE-0504645), a US National Institutes of Health grant 2R01GM068837_05A1 and the Helmholtz Alliance on Systems Biology and the BMBF by the NGFN+ neuroblastoma project ENGINE.
Source:
Daniel Kane
University of California - San Diego
The Alzheimer's insights demonstrate how fundamental insights on human metabolism can be gleaned from computer models that incorporate large genomic and proteomic data sets with information from biochemical studies. UC San Diego bioengineering professor Bernhard Palsson and his students and collaborators first developed this "in silico" modeling approach for E. coli and other prokaryotes, and later extended it to human tissues.
The Nature Biotechnology paper describes the first time this modeling approach has been used to capture how the metabolism of specific human cell types affect the metabolism of other cell types.
"In human tissues, different cells have different roles. We're trying to predict how the behavior of one cell type will affect the behavior of other cell types," said Nathan Lewis, a Ph.D. candidate in the Department of Bioengineering at the UC San Diego Jacobs School of Engineering and the first author on the Nature Biotechnology paper, which also includes authors from the University of Heidelberg, Massachusetts Institute of Technology, and the German Cancer Research Center (DKFZ).
Similar approaches can be used to identify potential off-target effects of drugs, provide insights on disease progression, and offer new tools for uncovering the underlying biological mechanisms in a wide range of human tissues and cell types.
Why Some Neurons Die First in the Alzheimer's Brain
In the brains of people with Alzheimer's disease, certain cells, such as glutamatergic and cholinergic neurons, tend to die in much larger numbers in moderate stages of Alzheimer's disease, while GABAergic neurons are relatively unaffected until later stages of the disease.
"There is a big question as to what is causing this cell-type specificity," said Lewis.
The researchers built Palsson Lab: Systems Biology Research Group computational models that captured the metabolic interactions between each of the three neuron types and their associated astrocyte cells. Next, the bioengineersknocked down ?±-ketoglutarate, a gene known to be damaged in patients with Alzheimer's disease, and let their models of brain metabolism run to see what happens.
The results from the models agreed with clinical data. When the bioengineers disrupted the ?±-ketoglutarate enzyme in the models for cholinergic and glutamatergic neurons, the metabolic rate of these neurons dropped, leading to cell death. "But then you have the GABAergic neurons that show no effect. So the cell types that are known to be lost early on in Alzheimer's show slowed metabolic rates," explained Lewis.
Analysis of their models then led the bioengineers to the biochemical pathways that allowed the GABAergic neurons to be relatively unaffected despite the disrupted gene.
"We looked at what upstream is allowing this and found a GABA-specific enzyme called glutamate decarboxylase," said Lewis.
When the researchers added this enzyme to the models of the other neuron types, the metabolic rates of these neurons improved as well. Thus the model allowed the researchers to identify a gene and how it contributes to the whole cell to potentially prolong the life of certain cells in Alzheimer's disease.
Large Scale Modeling of Metabolic Interactions
The new Nature Biotechnology paper uses the Alzheimer's brain study as an example of how to build models of metabolism that go one level deeper than previous work by taking into account the tissue microenvironment and metabolic interactions between specific cell types.
The models for each cell can be represented like a circuit, with certain inputs and outputs. For example, sugars, like glucose, are inputs, and the models detail how these inputs are used to build cell parts and secrete byproducts as outputs. The metabolic models the bioengineers built provide a means to study these networks.
For example, each cell type has different biochemical pathways that can take the sugars from point A to B. If you knock out a gene in between, the network might find a different route, produce different products, or predict cell death. When models for multiple cells are combined, additional insight can be gained since the inputs and outputs of each model begin to affect the other cells.
"There are many potential applications for these models. For example, this modeling approach could be useful for predicting off target side effects of drugs. You could theoretically take a cell line, throw a drug at it and see which metabolic pathways are significantly affected. Thus, you could decrease the amount of resources spent on drug development if the model suggests negative side effects that may cause it to fail," said Lewis.
Notes:
"Large-scale in silico modeling of metabolic interactions between cell types in the human brain," by Nathan E Lewis (1), Gunnar Schramm (2,5), Aarash Bordbar (1), Jan Schellenberger (3), Michael P Andersen (1), Jeffrey K Cheng (1), Nilam Patel (1), Alex Yee (1), Randall A Lewis (4), Roland Eils (2,5), Rainer K?¶nig (2,5) & Bernhard ?? Palsson (1); published online on November 21, 2010 in Nature Biotechnology.
(1) Department of Bioengineering, University of California, San Diego, La Jolla, California, USA.
(2) Department of Bioinformatics and Functional Genomics, Institute of Pharmacy and Molecular Biotechnology and Bioquant, University of Heidelberg, Heidelberg, Germany.
(3) Bioinformatics Program, University of California, San Diego, La Jolla, California, USA.
(4) Department of Economics, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
(5) Department of Theoretical Bioinformatics, German Cancer Research Center (DKFZ), Heidelberg, Germany.
This work was funded in part by a Fulbright fellowship, a National Science Foundation IGERT Plant Systems Biology training grant (no. DGE-0504645), a US National Institutes of Health grant 2R01GM068837_05A1 and the Helmholtz Alliance on Systems Biology and the BMBF by the NGFN+ neuroblastoma project ENGINE.
Source:
Daniel Kane
University of California - San Diego
среда, 24 августа 2011 г.
Combining Vitamins E and C May Reduce Risk of Alzheimer's
Contact: Kenna Brigham
410-955-6878
JAMA and Archives Journals Website
(JAMA = Journal of the American Medical Association)
CHICAGO (USA) - Elderly persons who take individual vitamin E and C supplements together may reduce their risk of Alzheimer disease (AD), according to an article in the January issue of The Archives of Neurology, one of the JAMA/Archives journals.
According to the article, the public health threat of AD will continue to grow as people live longer. Previous studies have shown that antioxidant vitamins may protect the brain against damage caused by free radicals and other reactive oxygen species - molecular byproducts of basic cellular metabolism.
Neurons are especially sensitive to damage caused by free radicals, which is believed to be partially responsible for the development of AD. Incorporating antioxidants (which help to neutralize these free radicals) into the diet through food or supplementation may help protect neurons.
Peter P. Zandi, Ph.D., of The Johns Hopkins University Bloomberg School of Public Health, Baltimore, and colleagues examined the relationship between antioxidant supplement use and risk of AD.
The researchers assessed the prevalence of dementia and AD in 4,740 elderly (65 years or older) residents of Cache County, Utah in 1995 to 1997 and collected information about supplement use.
These residents were followed-up in 1998 to 2000 for new cases of dementia or AD. The researchers identified 200 cases of AD (prevalent cases) between 1995 and 1997, and 104 new cases (incident cases) of AD during follow-up.
The researchers categorized participants as vitamin E users if they reported taking an individual supplement of vitamin E or a multivitamin containing more than 400 IU (international units) of vitamin E.
Vitamin C users reported taking vitamin C supplements or multivitamins containing at least 500 micrograms of ascorbic acid.
Individuals were classified as multivitamin users if they reported taking multivitamins containing lower doses of vitamin E or C.
The researchers found the greatest reduction in both prevalence and incidence of AD in participants who used individual vitamin E and C supplements in combination, with or without an additional multivitamin.
'Use of vitamin E and C (ascorbic acid) supplements in combination reduced AD prevalence [by about 78 percent] and incidence [by about 64 percent],' the authors write.
The researchers also found 'no appreciable association with the use of vitamin C alone, vitamin E alone, or vitamin C and multivitamins in combination,' and prevalence of AD.
'The current??? recommended daily allowance for vitamin E is 22 IU (15 micrograms), and for vitamin C (ascorbic acid), 75 to 90 micrograms,' the researchers write.
'Multivitamin preparations typically contain these approximate quantities of both vitamins E and C (more vitamin C in some instances), while individual supplements typically contain doses up to 1,000 IU of vitamin E and 500 to 1,000 micrograms or more of vitamin C (ascorbic acid). Our findings suggest that vitamins E and C may offer protection against AD when taken together in the higher doses available from individual supplements.'
To contact Peter P. Zandi, Ph.D., call Kenna Brigham at 410-955-6878.
(Arch Neurol. 2004;61:82-88. Available post-embargo at
archneurol)
Editor's Note: This study was supported by grants from the National Institutes of Health, Bethesda, Md., and a grant from the National Institute of Mental Health, Bethesda, Md.
For more information, contact JAMA/Archives Media Relations at 312-464-JAMA (5262) or e-mail mediarelationsjama-archives
410-955-6878
JAMA and Archives Journals Website
(JAMA = Journal of the American Medical Association)
CHICAGO (USA) - Elderly persons who take individual vitamin E and C supplements together may reduce their risk of Alzheimer disease (AD), according to an article in the January issue of The Archives of Neurology, one of the JAMA/Archives journals.
According to the article, the public health threat of AD will continue to grow as people live longer. Previous studies have shown that antioxidant vitamins may protect the brain against damage caused by free radicals and other reactive oxygen species - molecular byproducts of basic cellular metabolism.
Neurons are especially sensitive to damage caused by free radicals, which is believed to be partially responsible for the development of AD. Incorporating antioxidants (which help to neutralize these free radicals) into the diet through food or supplementation may help protect neurons.
Peter P. Zandi, Ph.D., of The Johns Hopkins University Bloomberg School of Public Health, Baltimore, and colleagues examined the relationship between antioxidant supplement use and risk of AD.
The researchers assessed the prevalence of dementia and AD in 4,740 elderly (65 years or older) residents of Cache County, Utah in 1995 to 1997 and collected information about supplement use.
These residents were followed-up in 1998 to 2000 for new cases of dementia or AD. The researchers identified 200 cases of AD (prevalent cases) between 1995 and 1997, and 104 new cases (incident cases) of AD during follow-up.
The researchers categorized participants as vitamin E users if they reported taking an individual supplement of vitamin E or a multivitamin containing more than 400 IU (international units) of vitamin E.
Vitamin C users reported taking vitamin C supplements or multivitamins containing at least 500 micrograms of ascorbic acid.
Individuals were classified as multivitamin users if they reported taking multivitamins containing lower doses of vitamin E or C.
The researchers found the greatest reduction in both prevalence and incidence of AD in participants who used individual vitamin E and C supplements in combination, with or without an additional multivitamin.
'Use of vitamin E and C (ascorbic acid) supplements in combination reduced AD prevalence [by about 78 percent] and incidence [by about 64 percent],' the authors write.
The researchers also found 'no appreciable association with the use of vitamin C alone, vitamin E alone, or vitamin C and multivitamins in combination,' and prevalence of AD.
'The current??? recommended daily allowance for vitamin E is 22 IU (15 micrograms), and for vitamin C (ascorbic acid), 75 to 90 micrograms,' the researchers write.
'Multivitamin preparations typically contain these approximate quantities of both vitamins E and C (more vitamin C in some instances), while individual supplements typically contain doses up to 1,000 IU of vitamin E and 500 to 1,000 micrograms or more of vitamin C (ascorbic acid). Our findings suggest that vitamins E and C may offer protection against AD when taken together in the higher doses available from individual supplements.'
To contact Peter P. Zandi, Ph.D., call Kenna Brigham at 410-955-6878.
(Arch Neurol. 2004;61:82-88. Available post-embargo at
archneurol)
Editor's Note: This study was supported by grants from the National Institutes of Health, Bethesda, Md., and a grant from the National Institute of Mental Health, Bethesda, Md.
For more information, contact JAMA/Archives Media Relations at 312-464-JAMA (5262) or e-mail mediarelationsjama-archives
воскресенье, 21 августа 2011 г.
Antipsychotic Drugs Have Too Many Side Effects For Alzheimer's Patients
Antipsychotic drugs, such as Zyprexa, Seroquel and Risperdal, have side effects which are greater than their benefits for Alzheimer's patients, say researchers from the USA. These drugs are regularly prescribed to treat psychosis and aggression in patients with Alzheimer's disease.
You can read about this new study in the New England Journal of Medicine (NEJM).
Study leader, Dr. Lon Schneider, Unviersity of Southern California, USA, said the drugs do have some effects in treating symptoms, when compared to a placebo. However, the intolerable side-effects they bring with them offset the benefits for this vulnerable population.
Antipsychotic drugs are commonly used for Alzheimer's patients, despite there being no compelling evidence that their benefits are greater than their shortcomings. This new study provides the evidence - showing the drawbacks tend to outweigh the benefits.
In this 42-site, double-blind, placebo-controlled trial, the team examined 421 Alzheimer's patients - they all also suffered from aggression, delusions, hallucinations and/or agitation. They were given either a placebo or one of the three antipsychotic drugs - olanzapine (mean dose, 5.5 mg per day), quetiapine (mean dose, 56.5 mg per day), risperidone (mean dose, 1.0 mg per day). All the patients were followed up during 36 weeks. Doses were adjusted as needed.
Eventually, 85% of patients stopped taking the prescription drugs - either because of the magnitude of the side-effects, or because they did not work. Between 26% - 32% of those on the prescription drugs improved, compared to 21% of those on the placebo.
The antipsychotic drugs made the patients gain weight, as well as making them confused and sleepy.
The team concluded that the prescription medications were no better than the placebo.
"Effectiveness of Atypical Antipsychotic Drugs in Patients with Alzheimer's Disease"
Lon S. Schneider, M.D., Pierre N. Tariot, M.D., Karen S. Dagerman, M.S., Sonia M. Davis, Dr.P.H., John K. Hsiao, M.D., M. Saleem Ismail, M.D., Barry D. Lebowitz, Ph.D., Constantine G. Lyketsos, M.D., M.H.S., J. Michael Ryan, M.D., T. Scott Stroup, M.D., David L. Sultzer, M.D., Daniel Weintraub, M.D., Jeffrey A. Lieberman, M.D., for the CATIE-AD Study Group
NEJM Volume 355:1525-1538 October 12, 2006 Number 15
Click here to see abstract online
Written by:
View drug information on Risperdal Oral Formulation; Seroquel; Zyprexa.
You can read about this new study in the New England Journal of Medicine (NEJM).
Study leader, Dr. Lon Schneider, Unviersity of Southern California, USA, said the drugs do have some effects in treating symptoms, when compared to a placebo. However, the intolerable side-effects they bring with them offset the benefits for this vulnerable population.
Antipsychotic drugs are commonly used for Alzheimer's patients, despite there being no compelling evidence that their benefits are greater than their shortcomings. This new study provides the evidence - showing the drawbacks tend to outweigh the benefits.
In this 42-site, double-blind, placebo-controlled trial, the team examined 421 Alzheimer's patients - they all also suffered from aggression, delusions, hallucinations and/or agitation. They were given either a placebo or one of the three antipsychotic drugs - olanzapine (mean dose, 5.5 mg per day), quetiapine (mean dose, 56.5 mg per day), risperidone (mean dose, 1.0 mg per day). All the patients were followed up during 36 weeks. Doses were adjusted as needed.
Eventually, 85% of patients stopped taking the prescription drugs - either because of the magnitude of the side-effects, or because they did not work. Between 26% - 32% of those on the prescription drugs improved, compared to 21% of those on the placebo.
The antipsychotic drugs made the patients gain weight, as well as making them confused and sleepy.
The team concluded that the prescription medications were no better than the placebo.
"Effectiveness of Atypical Antipsychotic Drugs in Patients with Alzheimer's Disease"
Lon S. Schneider, M.D., Pierre N. Tariot, M.D., Karen S. Dagerman, M.S., Sonia M. Davis, Dr.P.H., John K. Hsiao, M.D., M. Saleem Ismail, M.D., Barry D. Lebowitz, Ph.D., Constantine G. Lyketsos, M.D., M.H.S., J. Michael Ryan, M.D., T. Scott Stroup, M.D., David L. Sultzer, M.D., Daniel Weintraub, M.D., Jeffrey A. Lieberman, M.D., for the CATIE-AD Study Group
NEJM Volume 355:1525-1538 October 12, 2006 Number 15
Click here to see abstract online
Written by:
View drug information on Risperdal Oral Formulation; Seroquel; Zyprexa.
четверг, 18 августа 2011 г.
Quality-of-life for those with dementia in long-term residential care, USA
Recent estimates reveal that approximately 50 percent or one million residents in long-term care assisted living and nursing homes have dementia. This figure is expected to increase substantially as the population ages, making the need for dementia care staff training critical.
In a special issue of The Gerontologist released this month, 16 articles explored quality of life and specific care needs for people with dementia in assisted living and nursing homes. The volume, titled "Dementia Care and Quality of Life in Assisted Living and Nursing Homes," was made possible through a grant from the Alzheimer's Association and was guest edited by Richard Schulz, Ph.D, of the University Center for Social and Urban Research at The University of Pittsburgh.
"This research forms part of the foundation of the Alzheimer's Association Campaign for Quality Residential Care initiated to enhance care for individuals with dementia in long-term care residential settings," said Harry Johns, president and CEO of the Alzheimer's Association. "The findings of this research reinforce our Campaign and the Association's mission to support and improve the quality of lives of those with Alzheimer's, their families and caregivers."
By 2050, the number of people with Alzheimer's disease could reach 16 million and for many families, long-term residential care will be the care option of choice.
The Gerontologist is a refereed publication of The Gerontological Society of America, the oldest and largest national multidisciplinary scientific organization devoted to the advancement of gerontological research. Founded in 1945, its membership includes some 5,000+ researchers, educators, practitioners, and other professionals in the field of aging. The Society's principal missions are to promote research and education in aging and to encourage the dissemination of research results to other scientists, decision makers, and practitioners.
The Alzheimer's Association, the world leader in Alzheimer research and support, is the first and largest voluntary health organization dedicated to finding prevention methods, treatments and an eventual cure for Alzheimer's. For nearly 25 years, the donor-supported, not-for-profit Alzheimer's Association has provided reliable information and care consultation; created supportive services for families; increased funding for dementia research; and influenced public policy changes.
Todd Kluss
tklussgeron
The Gerontological Society of America
geron
In a special issue of The Gerontologist released this month, 16 articles explored quality of life and specific care needs for people with dementia in assisted living and nursing homes. The volume, titled "Dementia Care and Quality of Life in Assisted Living and Nursing Homes," was made possible through a grant from the Alzheimer's Association and was guest edited by Richard Schulz, Ph.D, of the University Center for Social and Urban Research at The University of Pittsburgh.
"This research forms part of the foundation of the Alzheimer's Association Campaign for Quality Residential Care initiated to enhance care for individuals with dementia in long-term care residential settings," said Harry Johns, president and CEO of the Alzheimer's Association. "The findings of this research reinforce our Campaign and the Association's mission to support and improve the quality of lives of those with Alzheimer's, their families and caregivers."
By 2050, the number of people with Alzheimer's disease could reach 16 million and for many families, long-term residential care will be the care option of choice.
The Gerontologist is a refereed publication of The Gerontological Society of America, the oldest and largest national multidisciplinary scientific organization devoted to the advancement of gerontological research. Founded in 1945, its membership includes some 5,000+ researchers, educators, practitioners, and other professionals in the field of aging. The Society's principal missions are to promote research and education in aging and to encourage the dissemination of research results to other scientists, decision makers, and practitioners.
The Alzheimer's Association, the world leader in Alzheimer research and support, is the first and largest voluntary health organization dedicated to finding prevention methods, treatments and an eventual cure for Alzheimer's. For nearly 25 years, the donor-supported, not-for-profit Alzheimer's Association has provided reliable information and care consultation; created supportive services for families; increased funding for dementia research; and influenced public policy changes.
Todd Kluss
tklussgeron
The Gerontological Society of America
geron
понедельник, 15 августа 2011 г.
Revealing A Surprising Link Between Diabetes And Alzheimer's Disease
Blindness, heart disease, nerve damage, and kidney failure are not the only complications facing the nation's estimated 24 million people with diabetes. Although not widely known, those with the disease face up to double the risk of developing Alzheimer's disease (AD) than non-diabetics, according to an article scheduled for the May 18 issue of Chemical & Engineering News, ACS' weekly newsmagazine.
C&EN senior editor Sophie Rovner explains in the article that people with diabetes tend to have a higher risk of getting AD, and possibly get it at an earlier age, than the general population. Five million people in the United States have Alzheimer's, a brain disorder that causes severe memory loss. Diabetes results from the body's inability to produce or use insulin. Newer research now suggests that insulin is critical for healthy nerve cells in the brain. As the hormone declines in the brains of people with Alzheimer's, so does their memory.
Some research even suggests that diabetes and Alzheimer's are part of the same disease process that affects different parts of the body and that Alzheimer's may be considered "Type 3" diabetes. If so, then doctors might treat Alzheimer's in the same way as diabetes, which includes giving patients insulin or other medications - including so-called "insulin sensitizing" drugs - the article states.
Source
American Chemical Society
C&EN senior editor Sophie Rovner explains in the article that people with diabetes tend to have a higher risk of getting AD, and possibly get it at an earlier age, than the general population. Five million people in the United States have Alzheimer's, a brain disorder that causes severe memory loss. Diabetes results from the body's inability to produce or use insulin. Newer research now suggests that insulin is critical for healthy nerve cells in the brain. As the hormone declines in the brains of people with Alzheimer's, so does their memory.
Some research even suggests that diabetes and Alzheimer's are part of the same disease process that affects different parts of the body and that Alzheimer's may be considered "Type 3" diabetes. If so, then doctors might treat Alzheimer's in the same way as diabetes, which includes giving patients insulin or other medications - including so-called "insulin sensitizing" drugs - the article states.
Source
American Chemical Society
пятница, 12 августа 2011 г.
Alzheimer's Foundation Of America Sets Standard Of Excellence For Dementia Settings
As part of its ongoing efforts to
raise the bar on dementia care, the Alzheimer's Foundation of America (AFA)
has developed a nationwide standard of excellence for settings that provide
care to individuals with Alzheimer's disease or related dementias.
The new initiative, called Excellence in Care, involves on-site
evaluations of dementia care settings and assistance in meeting the
comprehensive set of standards. The standards reflect what AFA believes to
be essential components of any quality dementia care program.
Facilities that comply with the standards will earn the status of AFA
Excellence in Care Dementia Program of Distinction.
This is believed to be the first national program involving standards
and on-site evaluation for dementia care settings, such as assisted living
and skilled nursing facilities, continuum of care residential communities,
adult day and adult day healthcare care programs.
"As the incidence of Alzheimer's disease continues to rise, this
population deserves to be cared for in settings that meet a gold standard.
Quality of life and safety are paramount," said Eric J. Hall, AFA's chief
executive officer.
"Through Excellence in Care, we hope to promote continual improvement
of care and best practices throughout the country. This program gives care
settings the opportunity to ensure that optimal care is given to their
clients, and it will assist families as they select programs for their
loved ones," he said.
AFA designed the program with input from the Avila Institute of
Gerontology, an AFA member organization based in Germantown, NY that
provides high-quality education programs, as well as other AFA member
organizations, national organizations and industry experts.
Areas of evaluation include the physical environment, safety
procedures, program activities, staff-client interaction, and training of
staff and families.
AFA's trained Excellence in Care specialists will conduct the on-site
evaluations, and they will collaborate with settings found to have
shortcomings to upgrade their programs to meet the requirements.
AFA's first class of Excellence in Care specialists was trained this
past month and will begin evaluating facilities that sign up for the
Excellence in Care program.
The Alzheimer's Foundation of America is a national nonprofit
organization headquartered in New York and is made up of hundreds of member
organizations that provide hands-on programs to meet the educational,
emotional, practical and social needs of families. AFA's services include a
toll-free hot line, counseling, educational materials, a free caregiver
magazine, and professional training. For information, call (toll-free)
866-AFA-8484 or visit alzfdn.
Alzheimer's Foundation of America
alzfdn
raise the bar on dementia care, the Alzheimer's Foundation of America (AFA)
has developed a nationwide standard of excellence for settings that provide
care to individuals with Alzheimer's disease or related dementias.
The new initiative, called Excellence in Care, involves on-site
evaluations of dementia care settings and assistance in meeting the
comprehensive set of standards. The standards reflect what AFA believes to
be essential components of any quality dementia care program.
Facilities that comply with the standards will earn the status of AFA
Excellence in Care Dementia Program of Distinction.
This is believed to be the first national program involving standards
and on-site evaluation for dementia care settings, such as assisted living
and skilled nursing facilities, continuum of care residential communities,
adult day and adult day healthcare care programs.
"As the incidence of Alzheimer's disease continues to rise, this
population deserves to be cared for in settings that meet a gold standard.
Quality of life and safety are paramount," said Eric J. Hall, AFA's chief
executive officer.
"Through Excellence in Care, we hope to promote continual improvement
of care and best practices throughout the country. This program gives care
settings the opportunity to ensure that optimal care is given to their
clients, and it will assist families as they select programs for their
loved ones," he said.
AFA designed the program with input from the Avila Institute of
Gerontology, an AFA member organization based in Germantown, NY that
provides high-quality education programs, as well as other AFA member
organizations, national organizations and industry experts.
Areas of evaluation include the physical environment, safety
procedures, program activities, staff-client interaction, and training of
staff and families.
AFA's trained Excellence in Care specialists will conduct the on-site
evaluations, and they will collaborate with settings found to have
shortcomings to upgrade their programs to meet the requirements.
AFA's first class of Excellence in Care specialists was trained this
past month and will begin evaluating facilities that sign up for the
Excellence in Care program.
The Alzheimer's Foundation of America is a national nonprofit
organization headquartered in New York and is made up of hundreds of member
organizations that provide hands-on programs to meet the educational,
emotional, practical and social needs of families. AFA's services include a
toll-free hot line, counseling, educational materials, a free caregiver
magazine, and professional training. For information, call (toll-free)
866-AFA-8484 or visit alzfdn.
Alzheimer's Foundation of America
alzfdn
вторник, 9 августа 2011 г.
Perceptive Informatics Introduces Medical Imaging Methodology To Accelerate Development Decisions About Alzheimer's Treatments
Perceptive Informatics, the industry's leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (Nasdaq: PRXL), announced that it has developed a robust medical imaging methodology for Central Nervous System (CNS) clinical trials involving Alzheimer's disease. The method, based on measuring ventricular size, provides a new approach to monitor brain atrophy in Alzheimer's disease and potential treatment effects. The technique was presented on April 26, 2009 in Seattle, Washington during an invitation-only meeting of the Alzheimer's Disease Neuroimaging Initiative (ADNI).
The advantages of this method include providing higher quality, reproducible, and regulatory compliant assessments with the potential to help clinical trial sponsors make better and faster development decisions about Alzheimer's treatments in development. To develop this method, the Perceptive Informatics team collected Magnetic Resonance Imaging (MRI) scans from the ADNI database using Perceptive's medical imaging system and regulatory compliant processes.
"It is more critical than ever that biopharmaceutical companies have the ability to make accurate go/no go decisions as early as possible for new compounds. Medical imaging is increasingly being used as a surrogate endpoint or biomarker of drug efficacy in all phases of CNS trials. With this new methodology, we believe that Perceptive's therapeutic area experts are able to help sponsors advance neuroimaging and bring important CNS treatments to patients sooner," said Kenneth G. Faulkner, Ph.D., Vice President of Medical Imaging, Perceptive Informatics.
"Based on ADNI data, measuring ventricular change may be one of the most robust outcomes for imaging progression of Alzheimer's disease. Perceptive has developed a novel method of ventricular measurement that accurately reflects brain atrophy," said James Paskavitz, M.D., Medical Director, Perceptive Informatics. "We believe that this method can support sponsors in reducing the time, cost, and risk associated with clinical development of Alzheimer's treatments by providing medical image data that informs early phase decisions and is reproducible for later phase, multi-center trials."
The Perceptive Informatics Medical Imaging Group has helped to develop and validate novel surrogate endpoints for a variety of CNS disorders. Perceptive offers a range of capabilities in the application of imaging techniques from early clinical development through late phase studies. The medical imaging team operates globally and services a wide range of therapeutic areas, including oncology, central nervous system, musculoskeletal, cardiovascular, and metabolism/endocrinology imaging.
ADNI is focused on defining the rate of progress of mild cognitive impairment and Alzheimer's disease, developing improved methods for clinical trials in this area, and providing a large database to improve design of treatment trials. A goal of ADNI is to provide information and methods to help lead to effective treatments for Alzheimer's disease, leading to effective prevention.
About Perceptive Informatics
Perceptive Informatics, a subsidiary of PAREXEL, is the industry's leading eClinical solutions provider. Perceptive Informatics offers unprecedented access to innovative eClinical technologies and resources, providing clinical trial sponsors, CROs, and other service providers with the benefits of an extensive line of products and services throughout the entire clinical development lifecycle. In August, 2008 Perceptive was joined with ClinPhone plc, and the newly combined organization offers eClinical software and services that increase the efficiency and productivity of clinical research. Perceptive's expansive product portfolio includes Interactive Voice and Web Response Systems (IVRS/IWRS), Medical Imaging, Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS) and Electronic Patient Reported Outcomes (ePRO) solutions, as well as eClinical systems integration and implementation services.
About PAREXEL International
PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, medical communications and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 69 locations throughout 52 countries around the world, and has over 9,400 employees.
This release contains "forward-looking" statements regarding future results and events. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "believes," "anticipates," "plans," "expects," "intends," "appears," "estimates," "projects," "targets," and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. The Company's actual future results may differ significantly from the results discussed in the forward-looking statements contained in this release. Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from recent restructurings; the loss, modification, or delay of contracts which would, among other things, adversely impact the Company's recognition of revenue included in backlog; the Company's dependence on certain industries and clients; the Company's ability to win new business, manage growth and costs, and attract and retain employees; the Company's ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business, including, but not limited to, the successful business integration and anticipated synergy achievements in connection with the ClinPhone acquisition; the impact on the Company's business of government regulation of the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry and competition within the biopharmaceutical services industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of exchange rate fluctuations and other international economic, political, and other risks. Such factors and others are discussed more fully in the section entitled "Risk Factors" of the Company's Quarterly Report on Form 10-Q for the quarter ended December 31, 2008 as filed with the SEC on February 9, 2009, which "Risk Factors" discussion is incorporated by reference in this press release. The forward-looking statements included in this press release represent the Company's estimates as of the date of this release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company's estimates or views as of any date subsequent to the date of this press release.
PAREXEL is a registered trademark of PAREXEL International Corporation, and Perceptive Informatics is a trademark of Perceptive Informatics, Inc. All other names or marks may be registered trademarks or trademarks of PAREXEL International Corporation, Perceptive Informatics, Inc. or their respective owners and are hereby acknowledged.
Source: PAREXEL International Corporation
The advantages of this method include providing higher quality, reproducible, and regulatory compliant assessments with the potential to help clinical trial sponsors make better and faster development decisions about Alzheimer's treatments in development. To develop this method, the Perceptive Informatics team collected Magnetic Resonance Imaging (MRI) scans from the ADNI database using Perceptive's medical imaging system and regulatory compliant processes.
"It is more critical than ever that biopharmaceutical companies have the ability to make accurate go/no go decisions as early as possible for new compounds. Medical imaging is increasingly being used as a surrogate endpoint or biomarker of drug efficacy in all phases of CNS trials. With this new methodology, we believe that Perceptive's therapeutic area experts are able to help sponsors advance neuroimaging and bring important CNS treatments to patients sooner," said Kenneth G. Faulkner, Ph.D., Vice President of Medical Imaging, Perceptive Informatics.
"Based on ADNI data, measuring ventricular change may be one of the most robust outcomes for imaging progression of Alzheimer's disease. Perceptive has developed a novel method of ventricular measurement that accurately reflects brain atrophy," said James Paskavitz, M.D., Medical Director, Perceptive Informatics. "We believe that this method can support sponsors in reducing the time, cost, and risk associated with clinical development of Alzheimer's treatments by providing medical image data that informs early phase decisions and is reproducible for later phase, multi-center trials."
The Perceptive Informatics Medical Imaging Group has helped to develop and validate novel surrogate endpoints for a variety of CNS disorders. Perceptive offers a range of capabilities in the application of imaging techniques from early clinical development through late phase studies. The medical imaging team operates globally and services a wide range of therapeutic areas, including oncology, central nervous system, musculoskeletal, cardiovascular, and metabolism/endocrinology imaging.
ADNI is focused on defining the rate of progress of mild cognitive impairment and Alzheimer's disease, developing improved methods for clinical trials in this area, and providing a large database to improve design of treatment trials. A goal of ADNI is to provide information and methods to help lead to effective treatments for Alzheimer's disease, leading to effective prevention.
About Perceptive Informatics
Perceptive Informatics, a subsidiary of PAREXEL, is the industry's leading eClinical solutions provider. Perceptive Informatics offers unprecedented access to innovative eClinical technologies and resources, providing clinical trial sponsors, CROs, and other service providers with the benefits of an extensive line of products and services throughout the entire clinical development lifecycle. In August, 2008 Perceptive was joined with ClinPhone plc, and the newly combined organization offers eClinical software and services that increase the efficiency and productivity of clinical research. Perceptive's expansive product portfolio includes Interactive Voice and Web Response Systems (IVRS/IWRS), Medical Imaging, Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS) and Electronic Patient Reported Outcomes (ePRO) solutions, as well as eClinical systems integration and implementation services.
About PAREXEL International
PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, medical communications and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 69 locations throughout 52 countries around the world, and has over 9,400 employees.
This release contains "forward-looking" statements regarding future results and events. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "believes," "anticipates," "plans," "expects," "intends," "appears," "estimates," "projects," "targets," and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. The Company's actual future results may differ significantly from the results discussed in the forward-looking statements contained in this release. Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from recent restructurings; the loss, modification, or delay of contracts which would, among other things, adversely impact the Company's recognition of revenue included in backlog; the Company's dependence on certain industries and clients; the Company's ability to win new business, manage growth and costs, and attract and retain employees; the Company's ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business, including, but not limited to, the successful business integration and anticipated synergy achievements in connection with the ClinPhone acquisition; the impact on the Company's business of government regulation of the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry and competition within the biopharmaceutical services industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of exchange rate fluctuations and other international economic, political, and other risks. Such factors and others are discussed more fully in the section entitled "Risk Factors" of the Company's Quarterly Report on Form 10-Q for the quarter ended December 31, 2008 as filed with the SEC on February 9, 2009, which "Risk Factors" discussion is incorporated by reference in this press release. The forward-looking statements included in this press release represent the Company's estimates as of the date of this release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company's estimates or views as of any date subsequent to the date of this press release.
PAREXEL is a registered trademark of PAREXEL International Corporation, and Perceptive Informatics is a trademark of Perceptive Informatics, Inc. All other names or marks may be registered trademarks or trademarks of PAREXEL International Corporation, Perceptive Informatics, Inc. or their respective owners and are hereby acknowledged.
Source: PAREXEL International Corporation
суббота, 6 августа 2011 г.
FDA Seeks To Include Those Most Affected By Alzheimer's Disease In The Drug Review Process
The U.S. Food and Drug Administration (FDA) has expanded its Patient Consultant and Patient Representative programs to include individuals in the early stages of Alzheimer's disease and their caregivers. The FDA made the change in response to a request by the Alzheimer's Association encouraging the agency to give people directly affected by Alzheimer's a more active role in the review and approval of new Alzheimer drugs.
"People who are living with this terrible disease have much to offer to the pharmaceutical industry, researchers and government regulators, and their voices must be heard," said Harry Johns, president and CEO of the Alzheimer's Association. "We are pleased that the FDA understands the value of involving Alzheimer families in regulatory decisions that affect them and appreciate that the agency was so responsive in expanding their patient consultant program."
Similar to the programs that already exist for those with cancer and Parkinson's disease, the Alzheimer patient consultants and representatives will participate in FDA advisory committee meetings and advise on topics such as clinical trial design and the development of guidelines for clinical research. Involving those with the disease and their primary caregivers will increase the FDA's capacity to make informed regulatory decisions that are sensitive to the needs and preferences of this population. Following rigorous training by FDA staff, all involved will have access to materials for review and the opportunity to offer input on a variety of issues.
The Alzheimer's Association's request to the FDA grew out of extensive conversations with families across the nation struggling with the disease, many of whom felt that the drug development process was not always responsive to their needs. The Association held a Research Roundtable meeting in Washington at which persons with Alzheimer's, family caregivers, researchers, FDA regulators and Alzheimer's Association leaders discussed the risk and benefit trade-offs involved in drug development.
Following the meeting, the Association published articles on the issue in its scientific journal and subsequently forwarded the recommendation on the patient consultancy program to the FDA. This was followed by meetings with FDA leadership to move the issue forward.
"The FDA has been quite open to working with the Alzheimer's Association on ways to increase the attention and priority of Alzheimer issues within the agency," said Stephen McConnell, vice president of Advocacy and Public Policy for the Alzheimer's Association. "The Alzheimer's Association's goal is to ensure treatments that are safe and effective can get through the regulatory review process as quickly and efficiently as possible, while also being responsive to the special perspective of those who will benefit from them. The FDA has been a willing partner with the Association in this effort."
About the Alzheimer's Association
The Alzheimer's Association is the leading voluntary health organization in Alzheimer care, support and research. Our mission is to eliminate Alzheimer's disease through the advancement of research; to provide and enhance care and support for all affected; and to reduce the risk of dementia through the promotion of brain health. Our vision is a world without Alzheimer's.
Alzheimer's Association
"People who are living with this terrible disease have much to offer to the pharmaceutical industry, researchers and government regulators, and their voices must be heard," said Harry Johns, president and CEO of the Alzheimer's Association. "We are pleased that the FDA understands the value of involving Alzheimer families in regulatory decisions that affect them and appreciate that the agency was so responsive in expanding their patient consultant program."
Similar to the programs that already exist for those with cancer and Parkinson's disease, the Alzheimer patient consultants and representatives will participate in FDA advisory committee meetings and advise on topics such as clinical trial design and the development of guidelines for clinical research. Involving those with the disease and their primary caregivers will increase the FDA's capacity to make informed regulatory decisions that are sensitive to the needs and preferences of this population. Following rigorous training by FDA staff, all involved will have access to materials for review and the opportunity to offer input on a variety of issues.
The Alzheimer's Association's request to the FDA grew out of extensive conversations with families across the nation struggling with the disease, many of whom felt that the drug development process was not always responsive to their needs. The Association held a Research Roundtable meeting in Washington at which persons with Alzheimer's, family caregivers, researchers, FDA regulators and Alzheimer's Association leaders discussed the risk and benefit trade-offs involved in drug development.
Following the meeting, the Association published articles on the issue in its scientific journal and subsequently forwarded the recommendation on the patient consultancy program to the FDA. This was followed by meetings with FDA leadership to move the issue forward.
"The FDA has been quite open to working with the Alzheimer's Association on ways to increase the attention and priority of Alzheimer issues within the agency," said Stephen McConnell, vice president of Advocacy and Public Policy for the Alzheimer's Association. "The Alzheimer's Association's goal is to ensure treatments that are safe and effective can get through the regulatory review process as quickly and efficiently as possible, while also being responsive to the special perspective of those who will benefit from them. The FDA has been a willing partner with the Association in this effort."
About the Alzheimer's Association
The Alzheimer's Association is the leading voluntary health organization in Alzheimer care, support and research. Our mission is to eliminate Alzheimer's disease through the advancement of research; to provide and enhance care and support for all affected; and to reduce the risk of dementia through the promotion of brain health. Our vision is a world without Alzheimer's.
Alzheimer's Association
среда, 3 августа 2011 г.
Research At The University Of Kent Identifies Significant Weakness In Dementia Screening
A research team led by Dr Alisoun Milne, a Senior Lecturer at the Tizard Centre, University of Kent, has identified weaknesses in the most widely employed dementia screening instrument currently used in primary care.
The team, which included three senior health care practitioners from the Kent and Medway NHS and Social Care Partnership Trust, conducted a study that included a review of research evidence, a systematic clinically informed evaluation of the most commonly used screening measures, and a survey of measures employed in primary care in Kent.
Although the survey revealed that the Mini Mental State Examination (MMSE) was the most widely used measure in Kent with as many as 51% of respondents using it as the only screening tool the review concluded that three other less commonly used instruments are easier to administer, clinically acceptable, more effective, and less affected by patient education, gender, and ethnicity. These are: the General Practitioner Assessment of Cognition (GPCOG), the Memory Impairment Screen (MIS), and the Mini-Cognitive Assessment Instrument (Mini-Cog). That all three have psychometric properties similar to the MMSE is also important.
Of the GPs surveyed, many actually expressed concern about limited availability of measures other than MMSE, little access to training and advice on screening, and a lack of national guidance. One GP summarised the views of many by stating that 'it would be very helpful if a standard screening tool could be recommended and made widely available . . . now!'
Dr Milne, a researcher in the field of gerontology, said: 'Although the MMSE is widely used in the UK, this project identifies the GPCOG, MIS and Mini-Cog as clinically and psychometrically robust and more appropriate for routine use in primary care. The study highlights a need for primary care staff to be offered training and advice on dementia screening including the use of instruments. Early diagnosis is one of the key aims of the National Dementia Strategy; improving the quality and consistency of dementia screening is a distinctive and yet pivotal dimension of achieving this important policy goal.'
Dr Milne also moved to reassure patients and family members who may have concerns about the findings. 'Anyone with concerns about their own, or their relatives, cognitive function or memory should consult their GP,' she said. 'Whatever the relative weaknesses of the MMSE are, it remains a safe and valid screening instrument. Further, it is likely to remain the instrument of choice for most GPs until national guidance is provided on dementia screening and early diagnosis taking account of evaluative clinically informed research of the type reported by us.'
'Screening for dementia in primary care: a review of the use, efficacy and quality of measures' by A. Milne (Tizard Centre), A. Culverwell (St Martin's Hospital, Canterbury), R. Guss (Medway Maritime Hospital, Gillingham), J. Tuppen (The Beacon, Ramsgate) and R. Whelton (Tizard Centre) is published in the October issue, Vol. 20 (5), of International Psychogeriatrics, the official journal of the International Psychogeriatric Association.
KENT UNIVERSITY
Canterbury
Kent
CT2 7NZ
kent.ac.uk
The team, which included three senior health care practitioners from the Kent and Medway NHS and Social Care Partnership Trust, conducted a study that included a review of research evidence, a systematic clinically informed evaluation of the most commonly used screening measures, and a survey of measures employed in primary care in Kent.
Although the survey revealed that the Mini Mental State Examination (MMSE) was the most widely used measure in Kent with as many as 51% of respondents using it as the only screening tool the review concluded that three other less commonly used instruments are easier to administer, clinically acceptable, more effective, and less affected by patient education, gender, and ethnicity. These are: the General Practitioner Assessment of Cognition (GPCOG), the Memory Impairment Screen (MIS), and the Mini-Cognitive Assessment Instrument (Mini-Cog). That all three have psychometric properties similar to the MMSE is also important.
Of the GPs surveyed, many actually expressed concern about limited availability of measures other than MMSE, little access to training and advice on screening, and a lack of national guidance. One GP summarised the views of many by stating that 'it would be very helpful if a standard screening tool could be recommended and made widely available . . . now!'
Dr Milne, a researcher in the field of gerontology, said: 'Although the MMSE is widely used in the UK, this project identifies the GPCOG, MIS and Mini-Cog as clinically and psychometrically robust and more appropriate for routine use in primary care. The study highlights a need for primary care staff to be offered training and advice on dementia screening including the use of instruments. Early diagnosis is one of the key aims of the National Dementia Strategy; improving the quality and consistency of dementia screening is a distinctive and yet pivotal dimension of achieving this important policy goal.'
Dr Milne also moved to reassure patients and family members who may have concerns about the findings. 'Anyone with concerns about their own, or their relatives, cognitive function or memory should consult their GP,' she said. 'Whatever the relative weaknesses of the MMSE are, it remains a safe and valid screening instrument. Further, it is likely to remain the instrument of choice for most GPs until national guidance is provided on dementia screening and early diagnosis taking account of evaluative clinically informed research of the type reported by us.'
'Screening for dementia in primary care: a review of the use, efficacy and quality of measures' by A. Milne (Tizard Centre), A. Culverwell (St Martin's Hospital, Canterbury), R. Guss (Medway Maritime Hospital, Gillingham), J. Tuppen (The Beacon, Ramsgate) and R. Whelton (Tizard Centre) is published in the October issue, Vol. 20 (5), of International Psychogeriatrics, the official journal of the International Psychogeriatric Association.
KENT UNIVERSITY
Canterbury
Kent
CT2 7NZ
kent.ac.uk
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