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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: Active Phase 3 study of Alzheimer Disease, sponsored by Eli Lilly and Company.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Time to clinical progression as measured by CDR. CDR is a clinician-rated scale that provides an overall assessment of the participant's stage on the spectrum of Alzheimer's Disease (AD) dementia
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 2,996 participants |
| Start Date | 2021-08-27 |
| Est. Completion | 2027-11 |
| Phase | Phase 3 |
What the registry record for NCT05026866 still lists
NCT05026866 is an interventional study that assigns participants to a tested intervention. Its 2,996 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 2,741-participant average among 306 other Alzheimer Disease trials with a reported enrollment target.
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 names 20 study sites across 3 states, led by 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.
Learn More About Clinical Trials
Similar trials for Alzheimer Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05026866's enrollment target sits among peer trials
2,996 19th of 306 higher than 288 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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