Alzheimer’s clinical trial reaches halfway mark for enrollment

PROVIDENCE – Rhode Island Hospital is recruiting local participants for an international clinical trial to test an investigational drug intervention that may reduce the risk and development of Alzheimer’s disease. The Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Disease, colloquially called A4, clinical trial is for individuals ages 65 to 85 who may be at risk for memory loss due to Alzheimer’s disease. The trial is funded in part by the National Institutes of Health.

“This multicenter trial has reached its halfway mark for A4 randomization goals in the U.S. and Canada, and is quickly approaching 50 percent of total international enrollment of 1,150 participants, including Australian enrollment,” Dr. Brian Ott, director of the Alzheimer’s Disease and Memory Disorders Center at Rhode Island Hospital, said in a statement. “A record number of 426 participants are in the screening process worldwide, but we still have a way to go to reach the finish line. The study would like to complete enrollment within the next year and close screening by the end of 2016.”

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 Alzheimer’s symptoms. The goal is to slow possible Alzheimer’s-related damage in the brain and to delay memory loss symptoms. The 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 scan to measure amyloid in the brain. Participants with normal thinking and memory abilities, an elevated amyloid level and who pass general health screening evaluations will be randomly assigned to receive the investigative antibody drug or a placebo, given by an intravenous infusion every four weeks. Participants will be monitored for the duration of the trial.

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Alzheimer’s affects more than 20,000 people in Rhode Island, five million people in the United States 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 nation’s top 10 that cannot be prevented, cured or even slowed.

For more information or to learn if you qualify, contact Kerstin Calia at (401) 444-9861 or kcalia@lifespan.org.

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