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Sarasota's Roskamp Institute Announces Positive Safety Data in,Human Clinical Study for Alzheimer's Disease

And Japanese Study Suggests the Drug Improves Memory

SARASOTA, Fla., March 22, 2007 /PRNewswire-FirstCall/ -- 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 fro m 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.

For more information please contact the Roskamp Institute in Sarasota (941) 752-2949, the Roskamp Institute Memory Center in Tampa (813) 979-2008, or visit us online at

CONTACT: Sarah Bascom or Kristen Bridges of The Roskamp Institute,+1-850-222-2140

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