AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment with Lecanemab in Participants with Preclinical Alzheimer’s Disease

  • Site Principal Investigator: Julio Rojas-Martinez, MD, PhD
  • Sponsor: Eisai Inc.
  • Status: Recruiting
  • Official Study Title: AHEAD 3-45 Study: A Placebo-Controlled, Double-Blind, Parallel-Treatment Arm, 216-Week Study to Evaluate Efficacy and Safety of Treatment With BAN2401 in Subjects with Preclinical Alzheimer’s Disease and Elevated Amyloid (A45 Trial) and in Subjects with Early Preclinical Alzheimer’s Disease and Intermediate Amyloid (A3 Trial)
  • ClinicalTrials.gov Identifier: NCT04468659
  • Conditions Studied: Preclinical or early preclinical Alzheimer’s disease (AD)
  • Intervention: Lecanemab and placebo control
  • Phase: Phase 3
  • Duration of Participation: 4 years

Purpose of the Study

The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial). For more details, please see the AHEAD study website.


What to Expect

Over the course of the 4 years you will:

  • Be randomly assigned to a study group: Lecanemab (study drug) or placebo (saline solution, containing no active drug product). You do not get to pick your study group. You and your study doctor will not know if you are on the study drug or placebo.
  • Come into the UCSF clinic for 22 study visits
  • Have 55 intravenous (into the vein, or IV) infusions of lecanemab or placebo every 4 weeks for about 4 years
  • Undergo brain scans (MRI and PET)
  • Complete questionnaires and undergo tests of your memory and daily functioning, including computerized testing
  • Undergo blood draws

Materials Needed Before Evaluation: A biomarker result that is predictive of intermediate or elevated brain amyloid at screening

Costs: No costs will be charged for any of the study procedures. Parking will be validated at UCSF public garages for all study visits, and participants will be reimbursed up to $50 for each scheduled visit to the clinic to help defray any incidental expenses incurred in the course of participating in this study.

Contact Information

Coordinator: Claudio Gamboa[email protected], 415.476.0669
Clinical Trials Nurse: Mary Koestler, RN, PhD, CCRC[email protected], 415.476.0661