February 14, 2012
KEY CLINICAL TRIAL OF ALZHEIMER'S DISEASE DRUG BEGINS IN EUROPE
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
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.
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 Institute's 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 regarding this news release, please contact Steve Klindt (email: firstname.lastname@example.org) or 941-752-2949 x390.
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