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ACTIVE NOT RECRUITING Phase 3

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 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Placebo
  • DRUG Lecanemab

Study Locations (20)

California

  • UCI MIND — Irvine
  • University of Southern California — Los Angeles
  • Hoag Memorial Hospital Presbyterian — Newport Beach
  • Stanford University — Palo Alto
  • Sharp Mesa Vista Hospital — San Diego
  • University of California, San Francisco — San Francisco
  • University of California, Davis — Walnut Creek

Florida

  • Advanced Clinical Research Network, Corp — Coral Gables
  • Brain Matters Research — Delray Beach
  • Mayo Clinic Jacksonville — Jacksonville
  • K2 Medical Research - The Villages — Lady Lake
  • K2 Medical Research, Llc — Maitland
  • Gonzalez MD & Aswad MD Health Sciences — Miami
  • Wien Center for Clinical Research — Miami Beach

Arizona

  • Banner Alzheimer's Institute — Phoenix
  • Banner Sun Health Research Institute — Sun City

District of Columbia

  • Georgetown University — Washington D.C.
  • Howard University — Washington D.C.

Alabama

  • University of Alabama, Birmingham — Birmingham

Connecticut

  • Yale University School of Medicine — New Haven

Trial Details

FieldValue
Enrollment Target 1,400 participants
Start Date 2020-07-14
Est. Completion 2031-01-16
Phase Phase 3

Sponsor

Eisai

71 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04468659

The ClinicalTrials.gov registry entry for NCT04468659 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 71 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Preclinical Alzheimer's Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04468659 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04468659 about?

NCT04468659 is a clinical study titled "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". 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 ...

What is the current status of trial NCT04468659?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,400 participants. The study started on 2020-07-14. Estimated completion is 2031-01-16.

What conditions does trial NCT04468659 study?

This clinical trial studies the following conditions: Preclinical Alzheimer's Disease, Early Preclinical Alzheimer's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04468659?

The interventions under investigation include: Placebo (DRUG), Lecanemab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04468659?

This trial is sponsored by Eisai, which has 71 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04468659 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial