The Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Disease (A4) Study

This phase 3, placebo-controlled, double-blind, parallel-group, bayesian adaptive randomized design and dose regimen-finding study to evaluate safety, tolerability and efficacy of Solanezumab in older individuals who have normal thinking and memory function but who may be at risk for developing Alzheimer’s disease (AD) memory loss sometime in the future. The A4 study aims to evaluate the whether a new investigational treatment can slow the memory loss caused by Alzheimer’s disease. The overall goal of the A4 study is to test whether decreasing amyloid with antibody investigational treatment can help slow the memory loss associated with amyloid buildup in some people.

The study drug is called Solanezumab, a humanized monoclonal antibody that targets amyloid beta.

You may be eligible for this study if you:

Are 65 to 85 years old
Have normal thinking and memory abilities
Have a study partner who can accompany you to some of the study visits and answer questions about your memory

What happens during the study?

A telephone screening will be conducted to determine if you are eligible to come in for an in-person screening visit. This screening visit to determine if you are eligible for the study. As part of the screening procedures, you will have a PET scan using Amyvid, an FDA-approved compound to determine the presence or absence of amyloid deposits in the brain.

If you are eligible, you will be enrolled in the study and receive either study drug Solanezumab or placebo intravenously every four weeks for a period of 3 years.

You will have tests of memory to assess the effects of the study drug, along with MRIs, physical examinations and EKGs to assess for drug safety.

Where is this study taking place?

Boston University Medical Center

Meet the team

Robert A. Stern, PhD – Principal Investigator
Wendy Qiu, MD, PhD – Study Physician
Jesse Mez, MD – Study Physician
Jane Mwicigi, MPH – Study Coordinator
Dawn Jacobs, MPH – Clinical Research Coordinator

More information

The A4 study is a landmark public-private partnership, funded by the National Institute on Aging, Eli Lilly and Company, and several philanthropic organizations. The A4 trial is coordinated by the Alzheimer’s Disease Cooperative Study.

Please call (617) 358-5382 or email JoinADC@bu.edu for more information and to participate.

Sponsor – Eli Lilly and Co.
Coordinating center – Alzheimer’s Disease Cooperative Study
Funding sponsor – National Institute on Aging
Study website – The A4 Study