Sponsor: The National Institutes of Health (NIH), in partnership with the pharmaceutical company Eisai
Primary Investigator: Hamid Okhravi, MD
Summary: During the early stages of Alzheimer's disease, amyloid protein forms plaques in the brain. The AHEAD study is a Phase 3 clinical trial that will test whether the study drug, Lecanemab (BAN2401), reduces brain amyloid buildup in people with increased risk of Alzheimer's disease. Study participants will be enrolled in one of two AHEAD trials based on whether they have intermediate or elevated levels of amyloid in their brain. Participants with intermediate amyloid (A-3) will receive BAN2401 (Lecanemab) or placebo once every four weeks via infusion for four years. Participants with elevated amyloid (A-45) will receive BAN2401 (Lecanemab) or placebo once every two weeks for about two years and then once every four weeks for the remainder of the study. At different points in the study, participants will have a positron emission tomography (PET) brain scan. A PET scan takes pictures of the brain, allowing researchers to see and track changes in the amount of amyloid and tau in a participants brain.
Point of Contact: Katie Banko, Clinical Research Coordinator, 757-446-0358, or Adiba Talibi, Research Assistant, 757-446-7258.
Additional Contact: GlennanCenterResearchTrials@evms.edu
To be eligible, participants must be:
- Male or Female, age 55-80 (inclusive)
- Patients 55 to 64 years of age must have one of the following risk factors for Alzheimer's disease:
- First-degree relative diagnosed with dementia before age 75, or
- Known to have at least one apolipoprotein E4 variant (AP0E4) allele, or
- Known before screening to have elevated brain amyloid according to previous PET or cerebrospinal fluid testing, or
- Individuals with past amyloid PET scans showing intermediate brain amyloid are eligible to be screened for this study, as long as the participant did not participate in any clinical studies involving anti-amyloid therapies after the PET scan
- Have not been diagnosed with Alzheimer's disease or another dementia
- Have a study partner who is willing to participate as a source of information and has approximately weekly contact with the patient (in-person, telephone, or electronic communication); however, sufficient contact such that the study investigator feels the study partner can provide meaningful information about the patient's daily function
- Willing and able to comply with all aspects of the protocol
- Additional inclusion criteria to be determined prior to enrollment
Additional Information:
