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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: Active Phase 3 study of Dementia and Alzheimers Disease, sponsored by Eli Lilly and Company.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Percentage of participants with occurrence of ARIA-E at Week 24 is reported here.

Conditions Studied

Dementia Alzheimers Disease Mental Disorders Nervous System Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Neurocognitive Disorders

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

FieldValue
Enrollment Target 1,175 participants
Start Date 2023-02-28
Est. Completion 2027-05
Phase Phase 3
Eli Lilly and Company

1,341 total trials

What the registry record for NCT05738486 still lists

NCT05738486 is an interventional study that assigns participants to a tested intervention. Its 1,175 participants enrollment target places it among the larger protocols in the corpus, below the 7,717-participant average among 199 other Dementia trials with a reported enrollment target (85% lower).

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 names 20 study sites across 3 states, led by 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.

Learn More About Clinical Trials

Similar trials for Dementia

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 NCT05738486's enrollment target sits among peer trials

1,175 32nd of 199 higher than 168 of 199 other Dementia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Dementia 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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Related registry views

Source: ClinicalTrials.gov NCT05738486, the US trial registry maintained by the National Library of Medicine. NCT05738486 (large enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.