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NCT05738486 · ClinicalTrials.gov registry record · Phase 3
A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)
A Phase 3 study of Dementia and Alzheimers Disease, sponsored by Eli Lilly and Company.
- Active
- Registry status
- Phase 3
- Development phase
- 1,175
- Enrollment target
- 20
- Study locations
NCT05738486 is a Phase 3 study of Dementia and Alzheimers Disease that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 1,175 participants, below the 7,717-participant average among 199 other Dementia trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 3 states.
The verdict
NCT05738486, a Phase 3 study of Dementia and Alzheimers Disease, is active but no longer recruiting, sponsored by Eli Lilly and Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,175 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA. Approximately 375 additional participants will be enrolled per addendum. The study will last approximately 91 weeks and include up to 26 visits in the main study.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dexamethasone
- DRUG Donanemab
Study Locations (20)
Florida
- JEM Research Institute - Atlantis
- VIN-Julie Schwartzbard - Aventura
- Excel Medical Clinical Trials - Boca Raton
- K2 Medical Research - Clermont
- Brain Matters Research - Delray Beach
- Neuropsychiatric Research Center of Southwest Florida - Fort Myers
- Finlay Medical Research - Greenacres City
- Infinity Clinical Research, LLC - Hollywood
- Jacksonville Center for Clinical Research - Jacksonville
- ClinCloud - Maitland - Maitland
- K2 Medical Research - Maitland
- ClinCloud - Viera - Melbourne
- Suncoast Clinical Research, Inc. - New Port Richey
- Renstar Medical Research - Ocala
- Charter Research - Winter Park - Orlando
- Progressive Medical Research - Port Orange
California
- Irvine Clinical Research - Irvine
- Healthy Brain Clinic - Long Beach
- California Neuroscience Research Medical Group, Inc. - Sherman Oaks
Arizona
- MD First Research - Chandler - Chandler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,175 participants |
| Start Date | 2023-02-28 |
| Est. Completion | 2027-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05738486
The ClinicalTrials.gov registry entry for NCT05738486 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,175 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,717-participant average among 199 other Dementia trials with a reported enrollment target (85% lower). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Dementia appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05738486 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT05738486 about?
NCT05738486 is a clinical study titled "A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)". This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA. Approximately 375 additional participants will ...
What is the current status of trial NCT05738486?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,175 participants. The study started on 2023-02-28. Estimated completion is 2027-05.
What conditions does trial NCT05738486 study?
This clinical trial studies the following conditions: Dementia, Alzheimers Disease, Mental Disorders, Nervous System Diseases, Central Nervous System Diseases.
What interventions are being tested in trial NCT05738486?
The interventions under investigation include: Placebo (DRUG), Dexamethasone (DRUG), Donanemab (DRUG).
Who is sponsoring clinical trial NCT05738486?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05738486 being conducted?
This trial has 20 study locations across Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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