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 trial is funded in part by the National Institutes of Health. For more information on the study, or to find out if you qualify, please contact Kerstin Calia, 401-444-9861, firstname.lastname@example.org.
|Brian Ott, MD, director of the Alzheimer’s Disease and Memory Disorders Center at Rhode Island Hospital
The study is run locally by Brian Ott, MD, director of the Alzheimer’s Disease and Memory Disorders Center at Rhode Island Hospital.
Who is eligible for this Alzheimer’s disease clinical trial?
The Anti-Amyloid Treatment in Asymptomatic Alzheimer’s study (the “A4 study” for short) is for older individuals (65 to 85 years of age) who may be at risk for memory loss due to Alzheimer’s disease (AD). Participants should be in good overall medical health and have minimal or no complaints about their current memory functioning. Participants will also need to have a “study partner” – someone to answer questions once a year about the participants’ memory and ability to carry out daily life activities.
What is involved in the trial?
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, which is three years. Periodically throughout the study, participants’ health will be monitored using assessments such as memory and thinking tests, ECGs to look at the heart rhythm, MRI scans to show changes in the brain, and blood and urine tests. People who do not show evidence of elevated brain amyloid will be asked to participate in a separate study. This group will not receive the study drug but will complete the same memory tests every six months to compare changes in memory and thinking over time.
What do researchers think the investigational drug will do to slow or stop cognitive decline?
Scientists believe that accumulation of amyloid protein the brain may play a key role in the eventual development of AD-related memory loss. Studies have shown that changes occur in the brain many years before a person shows the symptoms of Alzheimer’s disease dementia. AD-related damage to the brain probably begins many years before the symptoms of AD-related memory loss emerge. We now know the amyloid protein forms plaques in the brain. The buildup of the amyloid protein is thought to be a toxic substance that affects brain function. The A4 anti-amyloid investigational drug targets the amyloid build-up in the brain. 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. The A4 study will also test whether the anti-amyloid treatment can slow evidence of AD-related brain injury on imaging tests.
When will participants know if it’s working?
Researchers will analyze the findings at the end of the three-year study, comparing the results from the group taking the A4 investigational drug (anti-amyloid antibody) to the group who received the placebo. Those who complete the study may be asked if they would like to participate in another long-term study in which all participants will receive the A4 investigational drug.
Why is this important?
Alzheimer’s disease affects more than 20,000 people in Rhode Island, 5.4 million people in the U.S., and 35 million people worldwide. One out of every eight individuals (13 percent) over age 65 has Alzheimer’s disease. Nearly half (45 percent) of individuals over age 85 has Alzheimer’s disease. The estimated lifetime risk of AD is almost one in five (17.2 percent) for women, and more than one in 10 (9.1 percent) for men. 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. This new approach offers hope for an effective approach to treating this devastating illness through early intervention.