A4 Study

Alzheimer’s Study Seeks Patients with Memory Concerns

The Brain Health & Memory Center at University Hospitals Neurological Institute is seeking patients for the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s study (A4), a clinical study for older individuals (65 to 85 years of age) who may be at risk for memory loss due to Alzheimer’s disease.

The A4 study is investigating a new drug intervention that may reduce the impact of a protein known as amyloid or beta amyloid plaques in the brain. Scientists believe that accumulation of amyloid in the brain may play a key role in the eventual development of Alzheimer’s-related memory loss.

The A4 anti-amyloid investigational drug targets amyloid build-up in the brain with the aim of slowing memory loss associated with the development of Alzheimer’s disease.

Participant Selection

The A4 study will enroll 1,000 people between the ages of 65 through 85 with normal thinking and memory function but with evidence of amyloid plaque buildup in the brain. Physicians and researchers will use positron emission tomography (PET) amyloid imaging scans to determine whether a potential participant has evidence of elevated amyloid buildup. Individuals with elevated amyloid on the PET scan will be eligible to become participants in the A4 study.

People who do not show evidence of elevated brain amyloid may 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 cognition over time.

What Happens During the Study?

Participants enrolled in the A4 study will visit the clinical research site once a month for three years. Half the participants in the A4 study will receive the anti-amyloid investigational drug, and half will receive a placebo (non-active agent used for comparison). The drug and the placebo are given by an intravenous infusion every month.

Participants will need to have a study partner, someone to answer questions once a year about the patient’s memory and ability to perform daily life activities. We will also monitor study participants’ health throughout the study using assessments such as:

  • Memory and thinking tests
  • Electrocardiograms (EKG) to look at the heart
  • Magnetic resonance imaging (MRI) scans of the brain
  • Blood and urine tests

How to Enroll

To enroll in this trial, please call Maria Gross, RN, Clinical Research Nurse Specialist I, Brain Health & Memory Center, University Hospitals Cleveland Medical Center, at 216-464-6454. To learn more about the trial, visit www.a4study.org.

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