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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 | Clinical Trials | Clareo Health

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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

AHEAD 3-45 Study: A Placebo-Controlled, Double-Blind, Parallel-Treatment Arm, 216 Week Study With an Extension Phase 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)

NCT04468659•Eisai Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

55 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must meet all of the following criteria to be included in this study:
•1. Male or female, age 55 to 80 years inclusive at the time of informed consent, with a plasma biomarker result that is predictive of intermediate or elevated brain amyloid at Screening or known before Screening to have elevated or intermediate amyloid according to previous PET, cerebrospinal fluid (CSF), or plasma testing
•• Those 55 to 64 must have 1 of the following additional risk factors, given the relatively low rates of amyloid positivity less than (\<) 65 years, before screening:
•* First degree relative diagnosed with dementia onset before age 75, or
•* Known to possess at least 1 apolipoprotein E4 variant (APOE4) allele, or
•* Known before screening to have elevated brain amyloid according to previous plasma biomarker results, PET imaging, or CSF testing
•2. Global Clinical Dementia Rating (CDR) score of 0 at screening
•3. Mini Mental State Examination score greater than or equal to (\>=) 27 (with educational adjustments) at screening.
•4. Wechsler Memory Scale-Revised Logical Memory subscale II (WMS-R LM II) score at screening of \>=6
•5. A45 Trial: Elevated brain amyloid pathology by amyloid PET: defined as approximately greater than (\>) 40 Centiloids on screening scan A3 Trial: Intermediate levels of brain amyloid pathology by amyloid PET: defined as approximately 20 to 40 Centiloids on screening scan
+10 more criteria

Exclusion Criteria

•Participants who meet any of the following criteria will be excluded from this study:
•1. Females who are breastfeeding or pregnant at screening or baseline
•2. Females of childbearing potential who:
•• Within 28 days before study entry, did not use a highly effective method of contraception For sites outside of Europe, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception
•3. History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of screening
•4. Current or history within the past 2 years of psychiatric diagnosis or symptoms that, in the opinion of the investigator, could interfere with study procedures
•5. Contraindications to 3 Tesla magnetic resonance imaging (MRI) scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants (example, in-skull and cardiac devices other than those approved as safe for use in MRI scanners), or exhibit other significant pathological findings on brain MRI at Screening
•6. Hypersensitivity to any monoclonal antibody treatment
•7. Any immunological disease which is not adequately controlled, or which requires treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives of monoclonal antibodies), systemic immunosuppressants, or plasmapheresis during the study
•8. Bleeding disorder that is not under adequate control (including a platelet count \<50,000 or international normalized ratio \[INR\] \>1.5) at screening
+19 more criteria

Locations (107)

University of Alabama, Birmingham

Birmingham, Alabama, United States

Banner Alzheimer's Institute

Phoenix, Arizona, United States

Banner Sun Health Research Institute

Sun City, Arizona, United States

UCI MIND

Irvine, California, United States

University of Southern California

Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Stanford University

Palo Alto, California, United States

Sharp Mesa Vista Hospital

San Diego, California, United States

University of California, San Francisco

San Francisco, California, United States

University of California, Davis

Walnut Creek, California, United States

Key Dates

Start Date

July 14, 2020

Primary Completion Date

December 21, 2028

Completion Date

January 16, 2031

Last Updated

March 13, 2026

Enrollment

1,400

ESTIMATED participants

Conditions

Preclinical Alzheimer's DiseaseEarly Preclinical Alzheimer's Disease

Interventions

Lecanemab

DRUG

Placebo

DRUG

A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease

NCT06544616

Preclinical Alzheimer's Disease

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AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980)

NCT07158905

Alzheimer DiseasePreclinical Alzheimer's Disease

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease

AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980)

TRC-PAD Program: In-Clinic Trial-Ready Cohort

Concurrent Aerobic Exercise and Virtual Reality Cognitive Training

Amyloid Prediction in Early Stage Alzheimer's Disease Through Speech Phenotyping - PAST Extension