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NCT04437511 · ClinicalTrials.gov registry record · Phase 3
A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)
A Phase 3 study of Alzheimer Disease, sponsored by Eli Lilly and Company.
- Active
- Registry status
- Phase 3
- Development phase
- 1,736
- Enrollment target
- 20
- Study locations
NCT04437511: Active Phase 3 study of Alzheimer Disease, sponsored by Eli Lilly and Company.
NCT04437511 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 1,736 participants, below the 2,745-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (37% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04437511, 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
- 1,736 participants
- Enrollment target
- 20
- Study locations
Study Summary
The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease. Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab. Trial participants who were dosed with donanemab in the main study will be enrolled to a 3-year follow up addendum. No study drug will be administered during this follow up.
Primary Outcome
Integrated Alzheimer's Disease Rating Scale is used to assess whether donanemab slows down the clinical decline associated with AD compared with placebo. iADRS is an integrated assessment of cognition and daily function comprised of items from the ADAS-Cog13 and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). The scale ranges from 0 to 144, where lower scores indicate worse performance and higher score indicates better performance. Least Squar
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Donanemab
Study Locations (20)
California
- North County Neurology Associates - Carlsbad
- Wr- Pri, Llc - Encino
- Neuro-Pain Medical Center - Fresno
- Neurology Center of North Orange County - Fullerton
- Irvine Clinical Research - Irvine
- Kaizen Brain Center - La Jolla
- Senior Clinical Trials, Inc. - Laguna Hills
- Collaborative Neuroscience Research, LLC - Los Alamitos
- USC Keck School of Medicine - Los Angeles
- Clinical Research Institute - Los Angeles
- Neurovations - Napa
- Hoag Memorial Hospital Presbyterian - Newport Beach
Arizona
- Gilbert Neurology - Gilbert
- Xenoscience - Phoenix
- Banner Alzheimer's Institute - Phoenix
- Perseverance Research Center - Scottsdale
- Banner Sun Health Research Institute - Sun City
- Banner Alzheimer's Institute Tucson - Tucson
- Center for Neurosciences - Tucson
Arkansas
- Health Initiatives Research - Fayetteville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,736 participants |
| Start Date | 2020-06-19 |
| Est. Completion | 2028-11 |
| Phase | Phase 3 |
What the registry record for NCT04437511 still lists
NCT04437511 is an interventional study that assigns participants to a tested intervention. Its 1,736 participants enrollment target places it among the larger protocols in the corpus, below the 2,745-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (37% lower).
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.
NCT04437511 names 20 study sites across 3 states, led by California, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT04437511 about?
NCT04437511 is a clinical study titled "A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)". The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease. Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab. Trial participants who were dose...
What is the current status of trial NCT04437511?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,736 participants. The study started on 2020-06-19. Estimated completion is 2028-11.
What conditions does trial NCT04437511 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT04437511?
The interventions under investigation include: Placebo (DRUG), Donanemab (DRUG).
Who is sponsoring clinical trial NCT04437511?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04437511 being conducted?
This trial has 20 study locations across Arizona, Arkansas, 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 NCT04437511's enrollment target sits among peer trials
1,736 24th of 306 higher than 283 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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