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NCT05026866 · ClinicalTrials.gov registry record · Phase 3

A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)

A Phase 3 study of Alzheimer Disease, sponsored by Eli Lilly and Company.

Active
Registry status
Phase 3
Development phase
2,996
Enrollment target
20
Study locations

NCT05026866 is a Phase 3 study of Alzheimer Disease that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 2,996 participants, roughly in line with the 2,741-participant average among 306 other Alzheimer Disease trials with a reported enrollment target. The trial reports 20 study locations across 3 states.

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The verdict

NCT05026866, a Phase 3 study of Alzheimer Disease, is active but no longer recruiting, sponsored by Eli Lilly and Company.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
2,996 participants
Enrollment target
20
Study locations

Study Summary

The main purpose of this study is to evaluate the safety and efficacy of donanemab in participants with preclinical Alzheimer's Disease (AD) over up to 332 weeks. Approximately 800 additional participants will be enrolled in the 12-month Addendum 7 to assess safety of a different titration regimen.

Conditions Studied

Alzheimer Disease

Interventions

  • DRUG Placebo
  • DRUG Donanemab

Study Locations (20)

California

  • Care Access - Berkeley - Berkeley
  • Care Access - Beverly Hills - Beverly Hills
  • Velocity Clinical Research, Chula Vista - Chula Vista
  • Valley Clinical Trials, Inc. - Covina
  • Neurology Center of North Orange County - Fullerton
  • Care Access - Gilroy - Gilroy
  • Marvel Clinical Research - Huntington Beach
  • Care Access Research - Huntington Beach - Huntington Beach
  • Irvine Clinical Research - Irvine
  • Option Care - Irvine - Irvine
  • Kaizen Brain Center - La Jolla
  • Velocity Clinical Research, San Diego - La Mesa
  • Pacific Research Network - Lemon Grove

Arizona

  • Care Access - 801 South Power Road, Mesa - Mesa
  • Banner Alzheimer's Institute - Phoenix
  • Banner Alzheimer's Institute Tucson - Tucson
  • Center for Neurosciences - Tucson

Alabama

  • Parkway Medical Center - Birmingham
  • Alabama Psychiatry - Birmingham - Brookwood Medical Center Drive - Homewood
  • Rehabilitation & Neurological Services - Huntsville

Trial Details

FieldValue
Enrollment Target 2,996 participants
Start Date 2021-08-27
Est. Completion 2027-11
Phase Phase 3

Sponsor

Eli Lilly and Company

1,341 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05026866

The ClinicalTrials.gov registry entry for NCT05026866 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 2,996 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 2,741-participant average among 306 other Alzheimer Disease trials with a reported enrollment target. The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05026866 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Arizona, Alabama.

Frequently Asked Questions

What is clinical trial NCT05026866 about?

NCT05026866 is a clinical study titled "A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)". The main purpose of this study is to evaluate the safety and efficacy of donanemab in participants with preclinical Alzheimer's Disease (AD) over up to 332 weeks. Approximately 800 additional participants will be enrolled in the 12-month Addendum 7 to assess safety of a different titration regimen.

What is the current status of trial NCT05026866?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 2,996 participants. The study started on 2021-08-27. Estimated completion is 2027-11.

What conditions does trial NCT05026866 study?

This clinical trial studies the following conditions: Alzheimer Disease.

What interventions are being tested in trial NCT05026866?

The interventions under investigation include: Placebo (DRUG), Donanemab (DRUG).

Who is sponsoring clinical trial NCT05026866?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05026866 being conducted?

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

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.