AHEAD Study

STUDY BASICS

Are you between 55-80 years old? You may be eligible for a research study to help us get ahead of Alzheimer's disease before symptoms begin. Compensation is provided.

STUDY PURPOSE

The AHEAD Study is testing the investigational treatment called lecanemab (also known as BAN2401 or LEQEMBI) in people with amyloid in the brain who do not have clinical symptoms of Alzheimer's disease. Lecanemab was approved for the treatment of mild cognitive impairment or mild dementia due to Alzheimer's disease, with confirmed amyloid in the brain, by the US Food and Drug Administration (FDA). 

The immune system produces proteins, called antibodies, to help eliminate specific substances from the body. Lecanemab is a specific type of antibody produced in the lab, called a monoclonal antibody. It binds to amyloid in the brain and has been shown to reduce the amount of this abnormal protein. In a different study, lecanemab slowed the decline in cognition in some people with mild cognitive impairment or mild dementia due to Alzheimer's disease. The purpose of this study is to see if the investigational treatment, lecanemab, may help delay or prevent symptoms due to Alzheimer's disease before they begin.

COULD THIS STUDY BE RIGHT FOR YOU?

Eligible participants between 55-80:

• Are healthy adults 
• Have not been diagnosed with Alzheimer's Disease or another dementia

Eligible participants between 55-64 must have one of the following risk factors:

• A first degree relative diagnosed with dementia onset before age 75
• Known to possess at least 1 APOE4 gene
• Known to have elevated brain amyloid according to previous PET (positron emission tomography) or CSF (cerebrospinal fluid) testing 

WHAT PARTICIPANTS CAN EXPECT

We will ask you to identify a study partner (a family member or close friend who knows you well and can answer questions about your memory and functioning) to accompany you to your visits once a year. The clinic visits will include medical-neurological examinations; review of medications you are taking; interviews on mood, behavior and functioning; and paper and pencil memory tests. Diagnostic tests that will be done include blood tests; magnetic resonance imaging (MRI), which is an imaging method that looks at the structure of the brain; positron emission tomography (PET), which is an imaging method that measures metabolic changes in the brain; and an optional lumbar puncture (LP), a procedure in which a small amount of spinal fluid is removed from the lower spine. 

Once enrolled in the study, the investigational treatment, lecanemab or the placebo are given by an intravenous (IV) infusion. IV infusion means the investigational treatment or placebo will enter a person's body through a vein in their arm or hand.