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Recruiting Phase 2 Interventional

A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)

ClinicalTrials.gov ID: NCT07589595

Public ClinicalTrials.gov record NCT07589595. 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.

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ClinicalTrials.gov public records Last synced Sep 8, 2026, 10:57 PM EDT

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

Official title

A Phase 2 Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Donanemab in Participants With Early Cognitive Decline, at Least One Core Clinical Feature of Dementia With Lewy Bodies, and Confirmation of Alpha-Synuclein and Amyloid Co-pathology

Brief summary

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

The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.

Study identification

NCT ID
NCT07589595
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Eli Lilly and Company
Industry
Enrollment
350 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
55 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
May 19, 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028
Last update posted
Sep 7, 2026

2026 – 2028

United States locations

U.S. sites
42
U.S. states
16
U.S. cities
39
Facility City State ZIP Site status
TrialSphere Corp Chandler Arizona 85286 Recruiting
HonorHealth Research Institute Scottsdale Arizona 85251 Not yet recruiting
Profound Research LLC Carlsbad California 92011 Recruiting
Irvine Clinical Research Irvine California 92614 Recruiting
UCSD - Altman Clinical and Translational Research Institute (ACTRI) La Jolla California 92037 Not yet recruiting
Stanford Neuroscience Health Center Palo Alto California 94304 Not yet recruiting
CenExel Rocky Mountain Clinical Research Englewood Colorado 80113 Not yet recruiting
Ki Health Partners, LLc, dba New England Institute for Clinical Research Stamford Connecticut 06905 Not yet recruiting
JEM Research Institute Atlantis Florida 33462 Recruiting
VIN - Aventura Aventura Florida 33180 Recruiting
Brain Matters Research Delray Beach Florida 33445 Recruiting
Neuropsychiatric Research Center of Southwest Florida Fort Myers Florida 33912 Recruiting
Norman Fixel Institute for Neurological Diseases (FIND) Gainesville Florida 32608 Not yet recruiting
Mayo Clinic in Florida Jacksonville Florida 32224 Not yet recruiting
K2 Medical Research ORLANDO Maitland Florida 32751 Recruiting
BRP-Kendal Lakes Miami Florida 33175 Recruiting
Renstar Medical Research Ocala Florida 34471 Recruiting
Charter Research - Orlando Orlando Florida 32803 Recruiting
Axiom Brain Health LLC Tampa Florida 33609 Recruiting
Palm Beach Neurology West Palm Beach Florida 33407 Recruiting
Conquest Research Winter Park Florida 32789 Recruiting
Indiana University Health Neuroscience Center Indianapolis Indiana 46202 Recruiting
The University of Kansas - Clinical Research Center Fairway Kansas 66205 Not yet recruiting
Massachusetts General Hospital - Charlestown Charlestown Massachusetts 02129 Not yet recruiting
K2 Medical Research - Foxborough Foxborough Massachusetts 02035 Recruiting
Neurology Center of New England Foxborough Massachusetts 02035 Recruiting
Headlands Eastern MA LLC Plymouth Massachusetts 02360 Recruiting
QUEST Research Institute Farmington Hills Michigan 48334 Recruiting
Struthers Parkinson's Center Golden Valley Minnesota 55427 Not yet recruiting
Mayo Clinic in Rochester, Minnesota Rochester Minnesota 55905 Not yet recruiting
Citizens Memorial Hospital District Bolivar Missouri 65613 Recruiting
Summit Headlands Portland Oregon 97210 Recruiting
Oregon Health and Science University Portland Oregon 97239 Not yet recruiting
Pennsylvania Hospital Philadelphia Pennsylvania 19107 Not yet recruiting
Gadolin Research Beaumont Texas 77702 Recruiting
Kerwin Medical Center Dallas Texas 75231 Recruiting
Houston Methodist Hospital Houston Texas 77030 Not yet recruiting
The University of Texas Health Science Center at Houston Houston Texas 77054 Not yet recruiting
Central Texas Neurology Consultants Round Rock Texas 78681 Recruiting
The University of Texas Health Science Center San Antonio Texas 78229 Recruiting
Re:Cognition Health Fairfax Virginia 22031 Recruiting
EvergreenHealth Kirkland Washington 98034 Not yet recruiting

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 30 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07589595, 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 Sep 7, 2026 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07589595 live on ClinicalTrials.gov.

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