Key Clinical Trial of Alzheimer’s Disease Drug Begins in Europe
Drug Discovered by Roskamp Institute Research
SARASOTA, Fla.--(BUSINESS WIRE)-- 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.
In January, President Obama set a goal of developing effective ways to treat and prevent Alzheimer’s disease by 2025 and launched the National Alzheimer's Plan. A committee of Alzheimer's experts is advising the government on how to finalize the plan. An estimated 5.4 million Americans have Alzheimer's disease or similar dementias, and the number of cases is growing as the population ages. By 2050, 13 million to 16 million Americans are projected to have Alzheimer's disease, costing $1 trillion in medical and nursing home expenditures.
Mullan and Crawford have been studying Alzheimer’s disease for more than 20 years, moving from the UK to Florida in 1998 and then to Sarasota in 2003 with the opening of the Roskamp Institute, which is devoted to understanding causes and finding cures for 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: www.rfdn.org.
Steve Klindt, 941-752-2949 x 390
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