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A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)

Donanemab Follow-On Study: Safety, Tolerability, And Efficacy in Symptomatic Alzheimer's Disease With Validation of Remote Neuropsychological Assessments

NCT04640077•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The main goals of this study are to further determine whether the study drug donanemab is safe and effective in participants with Alzheimer's disease and to validate neuropsychological assessments administered over videoconferencing

Eligibility

Age

60 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participated in a double-blind treatment period of a sponsor-approved originating donanemab trial, for example the TRAILBLAZER-ALZ study.
•Have a study partner
•Stable symptomatic Alzheimer's Disease (AD) medications and other medication that may impact cognition for at least 30 days prior to randomization into Part A

Exclusion Criteria

•Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with outcome assessments or the analyses in this study.
•Have received treatment with a passive anti-amyloid immunotherapy after completion of originating donanemab study or received active immunization against Aβ in any other study.
•Poor venous access
•Contraindication to PET or MRI imaging

Locations (27)

Banner Alzheimer's Institute

Phoenix, Arizona, United States

UC Irvine-Institute for Memory Impairments and Neurological Disorders (UCI MIND)

Irvine, California, United States

Bradenton Research Center, Inc.

Bradenton, Florida, United States

Merritt Island Medical Research, LLC

Merritt Island, Florida, United States

Synexus Clinical Research US, Inc.

Orlando, Florida, United States

Advanced Research Consultants

Palm Beach Gardens, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

Intercoastal Medical Group - Hyde Park

Sarasota, Florida, United States

Stedman Clinical Trials

Tampa, Florida, United States

Indiana University

Indianapolis, Indiana, United States

Key Dates

Start Date

November 23, 2020

Primary Completion Date

February 27, 2024

Completion Date

February 27, 2024

Last Updated

June 13, 2025

Enrollment

ACTUAL participants

Conditions

Alzheimer DiseaseDementiaBrain DiseasesCentral Nervous System DiseasesCognitive Impairment

Interventions

No Intervention

OTHER

donanemab

DRUG

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

NCT07178210

Alzheimer DiseaseLymphatic Obstruction

View study

RECRUITINGEARLY_PHASE1

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

NCT04123314

Depressive SymptomsDepression+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)

Inclusion Criteria

Exclusion Criteria

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

[18F]F-DOPA Imaging in Patients With Autonomic Failure

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)

Testing the Pain Clinical Practice Guideline