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

NCT ID: NCT04640077

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-23
• Study Completion Date: 2024-02-27

Brief 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

Conditions

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Cognitive Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A: Validation of Remote Scale Assessments

Participants from the originating trials did not receive any drug in Part A. Participants were randomized 1:1 into two groups to have their cognitive and functional scales assessed.

Group 1: Cognitive/functional scale assessment at the study site (on-site), followed by an at-home assessment (VTC; video teleconference), or Group 2: Cognitive/functional scale assessment at home (VTC), followed by assessment on-site.

Total time in Part A was up to 24 weeks.

Group Type: OTHER

No Intervention

Intervention Type: OTHER

No intervention

Part B: Donanemab

Participants who had received placebo in the originating trials received 700 milligrams (mg) donanemab administered intravenously (IV) every 4 weeks (Q4W) for 3 doses, then 1400 mg donanemab administered IV Q4W for up to 48 weeks.

Group Type: EXPERIMENTAL

donanemab

Intervention Type: DRUG

Administered IV

Interventions

No Intervention

No intervention

Intervention Type: OTHER

donanemab

Administered IV

Intervention Type: DRUG

Other Intervention Names

LY3002813

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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

Josephson Wallack Munshower Neurology, PC

Indianapolis, Indiana, United States

The University of Kansas - Clinical Research Center

Fairway, Kansas, United States

Cotton O'Neil Clinical Research Center - Central Office

Topeka, Kansas, United States

Boston Center for Memory

Newton, Massachusetts, United States

Washington University

St Louis, Missouri, United States

Las Vegas Medical Research

Las Vegas, Nevada, United States

Advanced Memory Research Institute of New Jersey

Toms River, New Jersey, United States

Guilford Neurologic Research, PA

Greensboro, North Carolina, United States

Ohio State University

Columbus, Ohio, United States

Neurology Diagnostics, Inc.

Dayton, Ohio, United States

Abington Neurological Associates, Ltd.

Abington, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

National Clinical Research, Inc

Richmond, Virginia, United States

Bruyère Research Institute

Ottawa, Ontario, Canada

Toronto Memory Program

Toronto, Ontario, Canada

Clinique de la Mémoire de l'Outaouais

Gatineau, Quebec, Canada

Diex Recherche Sherbrooke Inc.

Sherbrooke, Quebec, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trials.lillytrialguide.com/en-US/trial/7tATxSc3LHXNDE2nVmdIY

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

Other Identifiers

I5T-MC-AACH

Identifier Type: OTHER

Identifier Source: secondary_id

17447

Identifier Type: -

Identifier Source: org_study_id