December 14, 2007
Sarasota's Roskamp Institute Highlights Positive Japanese Data that Validates its Ongoing Alzheimer's Disease Research
Third-Party Japanese Study Suggests Drug Improves Memory
Sarasota, Fla. The Roskamp Institute today announced that its promising new drug application for the treatment of Alzheimer's disease has received positive validation from an independent human clinical study conducted at the Tokyo Medical University in Japan. The study, which suggests the drug, Nilvadipine, can prevent the onset of Alzheimer's disease in patients with memory problems, is detailed in the International Journal of Geriatric Psychiatry, a highly prestigious medical research journal.
The Japanese study was conducted over the course of a 20-month period, where a group of 15 amnestic mild cognitive impairment (MCI) patients with essential hypertension were divided into two groups. A group of eight participants were randomly allocated to take the drug Nilvadipine, while the other seven remaining participants were designated to take the drug Amlodipine.
The study found that the group treated with Nilvadipine had stabilized their decline in memory over the 20 months; whereas, the group treated with Amlodipine had continued to suffer loss of cognitive function, which was double that of the small decline in the Nilvadipine controlled group.
"Although the study was conducted with a small sample size, this third-party validation is extremely encouraging, as there appears to be a strong protective effect from developing Alzheimer's in memory-troubled patients who were given Nilvadipine," said Dr. Michael Mullan, director of the Roskamp Institute, who has been researching the drug for its use in Alzheimer's disease.
The Roskamp Institute, which owns the worldwide proprietary rights to use Nilvadipine for Alzheimer's disease, has been conducting its own human clinical study in partnership with the Trinity College Institute of Neuroscience in Dublin, Ireland, and has recently reported in March that the use of the drug in Alzheimer's patients is receiving positive safety reviews.
While the drug, Amlodipine, is one of the top drugs sold in the United States for the treatment of hypertension (high blood pressure), Nilvadipine is currently not available in the U.S. However, the Roskamp Institute plans to introduce Nilvadipine to the U.S. Food and Drug Administration as a part of its phase II study early next year.
"As the authors of the Japan study propose, our Institute's researchers are planning to investigate whether the Japan study finding can be replicated in a larger participant study," said Dr. Fiona Crawford, associate director of the Roskamp Institute, who has been working alongside Dr. Mullan in researching Nilvadipine for its use in Alzheimer's disease. As we continue to move forward in our studies, we are hopeful that we are well on our way to finding a drug that will be useful in slowing down or preventing this devastating disease.
In addition, the Roskamp Institute is looking for volunteers who have been diagnosed with Alzheimer's disease or Multiple Sclerosis to participate in Roskamp's ongoing research studies. If you or someone you know is interested in participating, please contact our Clinical Trials Division at (941) 256-8018.
The Roskamp Institute is a not-for-profit research Institute located in Sarasota and Tampa, Florida, that is dedicated to understanding the causes of, and finding cures for, neuropsychiatric and neurodegenerative disorders and addictions with an emphasis on Alzheimer's disease. The Institutes Memory Clinics also offer comprehensive cognitive and medical assessment toward differential diagnosis of Alzheimer's disease and offers treatments and disease management options once the diagnostic evaluation is complete.
For more information, please contact the Roskamp Institute in Sarasota at (941) 752-2949, the Roskamp Institute Clinical Trials Division in Sarasota at (941) 256-8018, the Roskamp Institute Roskamp Institute Clinic in Tampa at (813) 979-2008, or visit us online at www.RoskampInstitute.com. For more information regarding this news release, please contact Sarah Bascom or Kristen Bridges at (850) 222-2140.
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