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NCT05108922 · ClinicalTrials.gov registry record · Phase 3
A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 148
- Enrollment target
NCT05108922: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT05108922 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 148 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05108922, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 148 participants
- Enrollment target
Study Summary
The main purpose of this study is to compare donanemab to aducanumab on brain amyloid plaque clearance in participants with early symptomatic Alzheimer's Disease (AD).
Primary Outcome
Amyloid deposition in the brain is one of the defining neuropathologic findings of Alzheimer's disease (AD). Amyloid PET scan assesses cerebral amyloid load using florbetapir tracer which is standardized into Centiloids for evaluation of AD. Florbetapir exhibits high affinity specific binding to amyloid plaques. Centiloid values on Centiloid scale is based on mean composite Standardized Uptake Value Ratio (SUVR) in cingulate, frontal, parietal and temporal cortexes using whole cerebellum as refe
Interventions
- DRUG Donanemab
- DRUG Aducanumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2021-11-16 |
| Est. Completion | 2023-09-19 |
| Phase | Phase 3 |
What the finished NCT05108922 record still lists
NCT05108922 is an interventional study that assigns participants to a tested intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Donanemab is the first listed.
NCT05108922 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05108922 about?
NCT05108922 is a clinical study titled "A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)". The main purpose of this study is to compare donanemab to aducanumab on brain amyloid plaque clearance in participants with early symptomatic Alzheimer's Disease (AD).
What is the current status of trial NCT05108922?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 148 participants. The study started on 2021-11-16. Estimated completion is 2023-09-19.
What interventions are being tested in trial NCT05108922?
The interventions under investigation include: Donanemab (DRUG), Aducanumab (DRUG).
Who is sponsoring clinical trial NCT05108922?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05108922's enrollment target sits among peer trials
148 1547th of 2000 higher than 451 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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