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AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid

NCT04468659 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1400

Last updated 2026-03-13

No results posted yet for this study

Summary

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). This study will also evaluate the long-term safety and tolerability of lecanemab in participants enrolled in the Extension Phase.

Conditions

  • Preclinical Alzheimer's Disease
  • Early Preclinical Alzheimer's Disease

Interventions

DRUG

Lecanemab

IV infusion.

DRUG

Placebo

IV infusion.

Sponsors & Collaborators

  • Alzheimer's Clinical Trials Consortium

    collaborator OTHER

  • Biogen

    collaborator INDUSTRY

  • National Institute on Aging (NIA)

    collaborator NIH

  • Eisai Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-14
Primary Completion
2028-12-21
Completion
2031-01-16
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Japan
  • Singapore
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04468659 on ClinicalTrials.gov