A research team today announced the launch of a European large-scale clinical trial of Nilvadipine, an Alzheimer's disease drug developed at the Roskamp Institute (www.rfdn.org) in Sarasota. More than 500 Alzheimer's patients in nine European countries will participate in the phase III trial designed to study the effectiveness of the medication.
"We believe that Nilvadipine blocks the production of amyloid proteins linked to Alzheimer's disease," said Roskamp Institute President and CEO Michael Mullan, M.D., Ph.D., who along with Associate Director Fiona Crawford, Ph.D., and Daniel Paris Ph.D. led the team that developed the drug. "That means Nilvadipine is aimed at addressing the actual disease, and not just the symptoms."
A consortium of medical teams from nine European countries is meeting in Ireland this week to plan the US$10 million multicenter study. Phase III studies are usually the last step in the regulatory process before a drug can move into clinical practice. The consortium, called NILVAD for Nilvadipine/Alzheimer's Disease, will involve participants from Ireland, England, Hungary, Greece, France, Sweden, Germany, Italy and the Netherlands.
The 500 participants, who have mild to moderate cognitive impairments, will begin the double-blind study this fall. Each participant will be followed for 18 months to see if the drug produces a change in cognitive abilities.
"We won't cure Alzheimer' disease without clinical trials," said Crawford, who added that major pharmaceutical companies have not been able to come up with an effective drug. "Currently, there are only eight interventions underway in phase III trial, and it's a tremendous achievement for a small research institute like ours to be part of the process."
In their Sarasota laboratories, Mullan, Paris and Crawford 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. In 2010, the institute completed a phase I/II clinical trial in Europe that focused on Nilvadipine's safety. "The initial results indicated that patients were able to tolerate the drug safely and appeared to benefit from treatment," said Mullan.