Thursday, February 5, 2009

Safety Of PF 04494700 In Mild To Moderate Alzheimer's Disease


This is a Phase II clinical trial that is currently recruiting participants. The good news is this study is open to anyone 50 years or older. There are 54 available locations all across the country.

Please note the inclusion criteria:
  • Mini Mental State Exam (MMSE) score between 14-26 (inclusive) at screening.
  • Participants must be receiving acetylcholinesterase inhibitors on a stable dose for at least 4 months prior to randomization

Please note the exclusion criteria:
  • Current evidence or history of neurological, psychiatric and any other illness that could contribute to non-Alzheimer's dementia.
  • Known history of familial AD or any evidence for early onset AD known or possibly associated with genetic mutations.
  • Evidence or history of diabetes mellitus Type 1 or Type 2.
  • History or symptoms of autoimmune disorders.

Sponsors and Collaborators: Alzheimer's Disease Cooperative Study (ADCS)
The drug being tested in this study seeks to stop the protein amyloid beta from binding to a receptor in the brain called RAGE (receptor for advanced glycation endproducts). In earlier studies, inhibiting the RAGE protein in animal models led to a reduction of plaque formation.
The researchers hope that by blocking plaque-caused nerve damage and inflammation, this drug will slow the progressive decline associated with Alzheimer’s disease in humans. But regardless of how the drug performs in the study, Ashford said the research is crucial to scientists’ understanding of the disorder.
Currently testing in 54 locations
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Alzheimer's patients needed for Stanford study

STANFORD, Calif. — A national team of scientists is trying to determine if an experimental drug, called a RAGE inhibitor, can help Alzheimer’s disease patients with memory loss and other symptoms. Researchers at the Stanford University School of Medicine are among those looking for people with mild to moderate Alzheimer’s disease to participate in this phase-2 clinical trial.

“The number of Alzheimer’s patients is expected to triple or even quadruple by the year 2050,” said J. Wesson Ashford, MD, PhD, who is leading the Stanford portion of the multicenter study. “We don’t want people to be completely infirm and unable to take care of themselves, so it’s important that we find some drugs that can prevent the problem.”

More than 5 million Americans suffer from Alzheimer’s, which is characterized by an excessive amount of proteins that build up in plaque deposits and cause damage to nerve cells and inflammation in the brain. The disease was recently ranked by the Centers for Disease Control and Prevention as the sixth-leading cause of death in the country, and societal costs of Alzheimer’s amount to nearly $150 billion each year.

The drug being tested in this study seeks to stop the protein amyloid beta from binding to a receptor in the brain called RAGE (receptor for advanced glycation endproducts). In earlier studies, inhibiting the RAGE protein in animal models led to a reduction of plaque formation.

The researchers hope that by blocking plaque-caused nerve damage and inflammation, this drug will slow the progressive decline associated with Alzheimer’s disease in humans. But regardless of how the drug performs in the study, Ashford said the research is crucial to scientists’ understanding of the disorder.

“This type of research helps us learn more about the disease and study it more effectively,” said Ashford, a senior research scientist with the Stanford/VA Aging Clinical Research Center, a joint project of Stanford University and the Veteran Affairs Palo Alto Health Care System.

During the 18-month, double-blind study, which will involve 400 volunteers at 40 sites nationwide, participants will receive either the drug or a placebo pill. Researchers will monitor the participants during regular visits and measure disease progression using standard cognitive tests. They will also examine various biological markers of the disease, using magnetic resonance imaging to measure the degree of shrinkage in the brain and positron emission topography to assess the extent of amyloid buildup in the brain.

Researchers are looking for people age 50 or older who have been diagnosed as having probable Alzheimer’s disease or dementia. They must be currently taking medication for their disease and have a caregiver or family member who can accompany them to each study visit.

Those who are interested in learning more about participating should contact Ellen Kim at (650) 496-2578 or the national Alzheimer’s Disease Education and Referral Center at (800) 438-4380.

The study is being conducted by the Alzheimer’s Disease Cooperative Study, a consortium of leading researchers supported by the National Institute on Aging, and is led by researchers at the University of California-San Diego. Funding for the study comes from Pfizer, which manufacturers the drug being tested.

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Stanford University Medical Center integrates research, medical education and patient care at its three institutions - Stanford University School of Medicine, Stanford Hospital & Clinics and Lucile Packard Children's Hospital. For more information, please visit the Office of Communication & Public Affairs site at http://mednews.stanford.edu/.