Sarasota's Roskamp Institute Announces Positive Safety Data In Human Clinical Study For Alzheimer's Disease

The Roskamp
Institute announced today that it has received positive preliminary results
in its major clinical study that is testing a promising new drug
application for the treatment of Alzheimer's disease. The clinical study,
which was first announced in September, is the first human clinical study
conducted by a Florida-based research institute as a result of its own
original research. Today's announcement also highlighted achievements with
the same drug in studies in Japan.


The drug, Nilvadipine, has not shown any major side effects in
Alzheimer's disease patients during the initial six months of the study
that is being conducted in partnership with the Trinity College Institute
of Neuroscience in Dublin, Ireland. "This is a good indication that this
drug will be safe in patients with Alzheimer's disease," said Dr. Michael
Mullan, Director of the Roskamp Institute. "A staggering number of drugs
fail once they go through their clinical studies due to safety issues.
After treating more than a dozen Alzheimer patients with Nilvadipine, we
can continue our studies because we have seen no serious side effects
related to the drug."


This pilot study was the first step in trying to develop a potential
treatment for Alzheimer's disease, and if it continues to be a success,
could change the direction of other studies of dementia. In pre-clinical
studies on mice, Nilvadipine was found to decrease the levels in the brain
of a protein called beta amyloid. It is the presence of beta amyloid in the
brain that is believed to cause the onset of Alzheimer's. The drug was also
found to increase the flow of blood to the brain, which is believed to be
beneficial in the treatment of the disease. The purpose of the study has
been to determine whether the drug would have the same effect on humans
suffering from Alzheimer's as it did in the pre-clinical studies on mice.


"While the Roskamp Institute and team of top neuroscience researchers
in Ireland are still in the early phases of studying Nilvadipine, it is a
great accomplishment that at this stage we are seeing such a strong safety
profile in our patients," said Dr. Fiona Crawford, Associate Director of
the Roskamp Institute.


Meanwhile other researchers in Japan are independently reporting
results that support the idea that Nilvadipine will be useful for treating
Alzheimer's disease. Patients in the early stages of the disease have shown
increases in blood flow to the brain and did better on memory tests when
treated with Nilvadipine compared to another antihypertensive drug,
Amlodipine.


"These early results are encouraging and allow us to proceed with
studies looking more closely at whether this drug is going to be useful to
slow down or prevent this dreadful disease." Dr. Mullan added.


The Roskamp Institute is devoted to understanding causes of, and
finding cures for, diseases of the mind like neuropsychiatric and
neurodegenerative disorders and addictions. The Institute utilizes a broad
range of scientific approaches to understanding the causes of and potential
therapies for these disorders with an emphasis on Alzheimer's disease.


The Roskamp Institute

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