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Active, not recruiting Phase 3 Interventional Results available

A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

ClinicalTrials.gov ID: NCT05738486

Public ClinicalTrials.gov record NCT05738486. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 10:12 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 in addendum 2. Addendum 3 includes a subset of participants from the main study to receive a single dose. The study will last approximately 91 weeks and include up to 26 visits in the main study.

Study identification

NCT ID
NCT05738486
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Eli Lilly and Company
Industry
Enrollment
1,175 participants

Conditions and interventions

Eligibility (public fields only)

Age range
60 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 28, 2023 (Actual)
Primary completion
May 16, 2024 (Actual)
Completion
May 2027 (Estimated)
Last update posted
Jun 18, 2026

2023 – 2027

United States locations

U.S. sites
43
U.S. states
12
U.S. cities
41
Facility City State ZIP Site status
MD First Research - Chandler Chandler Arizona 85286 —
Irvine Clinical Research Irvine California 92614 —
Healthy Brain Clinic Long Beach California 90804 —
California Neuroscience Research Medical Group, Inc. Sherman Oaks California 91403 —
JEM Research Institute Atlantis Florida 33462 —
VIN-Julie Schwartzbard Aventura Florida 33180 —
Excel Medical Clinical Trials Boca Raton Florida 33434 —
K2 Medical Research Clermont Florida 34711 —
Brain Matters Research Delray Beach Florida 33445 —
Neuropsychiatric Research Center of Southwest Florida Fort Myers Florida 33912 —
Finlay Medical Research Greenacres City Florida 33467 —
Infinity Clinical Research, LLC Hollywood Florida 33024 —
Jacksonville Center for Clinical Research Jacksonville Florida 32216 —
ClinCloud - Maitland Maitland Florida 32751 —
K2 Medical Research Maitland Florida 32751 —
ClinCloud - Viera Melbourne Florida 32940 —
Suncoast Clinical Research, Inc. New Port Richey Florida 34652 —
Renstar Medical Research Ocala Florida 34470 —
Charter Research - Winter Park Orlando Florida 32803 —
Progressive Medical Research Port Orange Florida 32127 —
Alzheimer's Research and Treatment Center Stuart Florida 34997 —
K2 Medical Research - Tampa Tampa Florida 33607 —
K2 Summit Research The Villages Florida 32159 —
Charter Research - Lady Lake The Villages Florida 32162 —
Alzheimer's Research and Treatment Center Wellington Florida 33414 —
Palm Beach Neurology West Palm Beach Florida 33407 —
Conquest Research Winter Park Florida 32789 —
Columbus Memory Center, LLC Columbus Georgia 31909 —
CenExel iResearch, LLC Decatur Georgia 30030 —
Center for Advanced Research & Education Gainesville Georgia 30501 —
CenExel iResearch, LLC Savannah Georgia 31405 —
MedVadis Research Corporation Waltham Massachusetts 02451 —
Adams Clinical Watertown Massachusetts 02472 —
QUEST Research Institute Farmington Hills Michigan 48334 —
The Cognitive and Research Center of New Jersey Springfield New Jersey 07081 —
Butler Hospital Providence Rhode Island 02906 —
Neurology Clinic, P.C. Cordova Tennessee 38018 —
Gadolin Research Beaumont Texas 77702 —
Kerwin Medical Center Dallas Texas 75231 —
The University of Texas Health Science Center at Houston Houston Texas 77054 —
Re:Cognition Health Fairfax Virginia 22031 —
Northwest Clinical Research Center Bellevue Washington 98007 —
Universal Research Group Tacoma Washington 98405 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05738486, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 18, 2026 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05738486 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →