Only a handful of Alzheimer’s drugs have not reached this stage, and most were developed by large pharmaceutical companies. It is a remarkable achievement for a research institution like ours to be part of the process, said Crawford .In the laboratories of Sarasota, the research team found that Nilvadipine, a drug approved in Europe for the treatment, can stop the accumulation of amyloid in the brain – a development that has been implicated in Alzheimer’s disease. A combined phase I / II clinical study has been completed in Europe by the Institute last year and focused on the safety of Nilvadipine. The initial results indicate that patients with Alzheimer’s disease were able to tolerate the drug well, said Mullan.
We need many more drugs to make progress in advanced clinical testing in the fight against Alzheimer’s disease and we are happy with the Roskamp Institute has played an important role in the development of this drug, said Michael Mullan, MD, Ph . D., director of the Roskamp, along with Associate Director Fiona Crawford, Ph.D., and chief scientist Daniel Paris, Ph.D., led the research team that developed the drug. Phase III trials are usually the last step in the regulatory process before a drug can move into clinical practice.
Given the devastating impact of Alzheimer’s disease has on people, there is relatively little research funding available to address this great murderess, said Lawlor.
Brian Lawlor, MD, Connolly Norman Professor of Psychiatry of old age at Trinity College Dublin, Ireland, will be principal investigator and study coordinator Nilvadipine U.S. $ 8.4 million, which is funded by the Seventh Framework Programme of the European Commission. Over 20 clinical sites participating in the European placebo-controlled study. Should begin in early 2012, patients with mild to moderate Alzheimer’s disease will be recruited to participate.
Clinical trials take place in Europe where Nilvadipine is already approved for use in mild cases of hypertension (). The process can move much faster in Europe, and the conclusions of the study can help speed the process with the Food and Drug Administration (FDA), said Mullan.
Business Benefits Institute, Archer Pharmaceuticals, owns the intellectual property rights and serves as an officer Nilvadipine Mullan Archer Management. There are always risks in drug development and discovery, said Mullan. However, we must continue to invest in new approaches in the global fight against Alzheimer’s disease.
Mullan and Crawford has studied Alzheimer’s for over 20 years, moving from the United Kingdom in Florida in 1991 and in Sarasota in 2003 to found the Roskamp Institute. Some of our recent studies have involved residents in the Sarasota area, who have contributed to our understanding of Alzheimer’s and helped advance the development process, said Crawford.