SARASOTA, FL – An international research consortium led by Trinity College Dublin (Ireland) today announced the selection for funding of a large-scale European clinical trial of Nilvadipine, an Alzheimer’s disease drug developed at the Roskamp Institute in Sarasota. More than 500 Alzheimer’s patients will participate in the multicenter Phase III clinical trial designed to study the effectiveness of Nilvadipine.
“We need many more medicines to move forward into advanced clinical trials in the fight against Alzheimer’s Disease and we are pleased the Roskamp Institute has played such a major role in the development of this drug,” said Michael Mullan, M.D., Ph.D., Roskamp Institute director who, with associate director Fiona Crawford, Ph.D. and lead scientist Daniel Paris, Ph.D., led the research team that developed the drug. Phase III studies are usually the last step in the regulatory process before a drug can move into clinical practice.
“Only a handful of Alzheimer’s drugs have ever reached this stage, and most were developed by major pharmaceutical companies. It’s a tremendous achievement for a research institute like ours to be part of the process,” said Crawford.
Brian Lawlor, M.D., Connolly Norman Professor of Old Age Psychiatry at Trinity College Dublin, Ireland, will be principal investigator and coordinator of the US$ 8.4 million Nilvadipinestudy, which is being funded by the European Commission Seventh Framework Programme. More than 20 European clinical sites will participate in the placebo-controlled study. Anticipated to begin in early 2012, patients with mild to moderate Alzheimer’s disease will be recruited to participate.
“Considering the devastating impact that Alzheimer’s disease has on people, there is relatively little research funding being made available to tackle this major killer,” said Lawlor.
The clinical trials will take place in Europe, where Nilvadipine is already approved for use in mild cases of hypertension (high blood pressure). “The process can move more quickly in Europe, and the study findings may help accelerate the process with the U.S. Food and Drug Administration (FDA),” Mullan said.
Mullan and Crawford have been studying Alzheimer’s disease for more than 20 years, moving from the UK to Florida in 1991 and to Sarasota in 2003 to establish the Roskamp Institute. “Some of our recent studies have involved Sarasota area residents, who have contributed to our understanding of Alzheimer’s disease and helped move the development process forward,” said Crawford.
In the Sarasota laboratories, the research team discovered that Nilvadipine, a drug approved in Europe for treatment of hypertension, can stop the accumulation of the amyloid proteins in the brain – a development that has been implicated in Alzheimer’s disease. A combined Phase I/II clinical trial was completed in Europe by the Institute last year and focused on Nilvadipine’s safety. “The initial results indicated that patients with Alzheimer’s disease were able to tolerate the drug well,” said Mullan.
Now, the Roskamp Institute will provide research support for the Phase III clinical trial, such as assessing genetic and other markers for Alzheimer’s disease in study participants.
The Institute’s commercial spinoff, Archer Pharmaceuticals, owns the intellectual property rights to Nilvadipine, and Mullan serves as Archer’s chief executive officer. “There are always risks involved with drug development and discovery,” said Mullan. “But we must continue to invest in new approaches in the worldwide battle against Alzheimer’s disease.”
The Roskamp Institute is devoted to understanding causes and finding cures for neuropsychiatric and neurodegenerative disorders. 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 Institute is located in Sarasota, Florida, and operates a memory clinic onsite.
For more information: www.rfdn.org
