Rhode Island Hospital Recruiting for Alzheimer’s Disease Clinical Trial

June 11, 2014

Study to measure efficacy of drug designed to reduce risk, development of Alzheimer’s disease

Rhode Island Hospital is recruiting local participants for a national clinical trial to test a new investigational drug intervention that may reduce the risk and development of Alzheimer’s disease.  The Anti-amyloid Treatment in Asymptomatic Alzheimer’s disease (A4) clinical trial is for individuals ages 65 to 85 who may be at risk for memory loss due to Alzheimer’s disease. It will test a new investigational drug that may reduce the impact of amyloid or Beta amyloid proteins that form plaques in the brain, which may lead to Alzheimer’s.  The trial is funded in part by the National Institutes of Health (NIH).

“Research has shown that changes occur in the brain many years before memory loss and other signs of Alzheimer’s or dementia begin to appear,” said Brian Ott, MD, director of the Alzheimer’s Disease and Memory Disorders Center at Rhode Island Hospital. “This study will help to determine if identifying and blocking these toxic proteins will reduce the risk and eventual development of Alzheimer’s in individuals who are at risk, but who are not yet showing symptoms of memory loss.”

The A4 study is testing an anti-amyloid investigational drug in older individuals who have evidence of elevated amyloid accumulation in their brain but who do not yet show symptoms of Alzheimer’s disease. The goal is to slow possible Alzheimer’s-related damage in the brain and to delay symptoms of memory loss. The investigational drug, which binds to amyloid proteins, is expected to slow decline in memory and thinking as measured by cognitive tests, if treatment is started before there is evidence of Alzheimer’s-related symptoms and brain injury.

Each participant is required to undergo a Positron Emission Tomography (PET) scan to measure amyloid in the brain. Participants with normal thinking and memory abilities, an elevated amyloid level, and who pass screening evaluations of their general health, will be randomly assigned to receive either the investigative antibody drug or a placebo. The drug and placebo are given by an intravenous infusion every four weeks. Participants will be monitored for the duration of the trial.

Alzheimer’s disease affects more than 20,000 people in Rhode Island, 5 million people in the U.S., and 35 million people worldwide. It is the sixth-leading cause of death in the United States and the only cause of death among the top 10 in the United States that cannot be prevented, cured or even slowed.

For more information on the study, or to find out if you qualify, please contact Kerstin Calia, 401-444-9861, kcalia@lifespan.org.