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

NCT04640077 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 17447I5T-MC-AACH
• Study Type: interventional
• Target: 95
• Locations: 2 countries
• Sites: 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

Outcome Measures

Primary Outcomes (3)

• Part A: Intraclass Correlation Between On-Site and Video Teleconference (VTC) Assessments

  Part A didn't involve any drug and drug related efficacy analyses. Participants in Part A were divided into 2 groups, and they completed the same set of clinical assessments. Participants in Part A Group 1 completed the clinical assessments at a clinic site first (on-site) followed by at home assessments (VTC). Participants in Part A Group 2 completed the assessments at home first, followed by on-site assessment. The goal of Part A was to evaluate the comparability of remote and on-site clinical assessments. The intra-class correlation coefficient (ICC), a measure of agreement for continuous outcome measures, was used to determine agreement between remote and onsite assessments for each outcome measure. Outcome measure tested were the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog13), Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL), Mini Mental State Examination (MMSE), and Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB).

  Baseline to 4 Weeks

• Part B: Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Percentage of participants with TEAEs and SAEs were reported here. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.

  Baseline Up To 96 Weeks

• Part B: Number of Participants With Suicidality Based on Columbia-Suicide Severity Rating Scale (C-SSRS)

  Number of Participants with Suicidality Based on C-SSRS was reported.

  Baseline, Week 72

Secondary Outcomes (9)

• Part B: Change From Baseline on the Mini Mental State Examination (MMSE) Score

  Baseline, Week 72

• Part B: Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score

  Baseline, Week 72

• Part B: Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)

  Baseline, Week 72

• Part B: Change From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL)

  Baseline, Week 72

• Part B: Change From Baseline on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)

  Baseline, Week 72

Study Arms (2)

Part A: Validation of Remote Scale Assessments

OTHER

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.

Other: No Intervention

Part B: Donanemab

EXPERIMENTAL

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.

Drug: donanemab

Interventions

No Intervention OTHER

No intervention

Part A: Validation of Remote Scale Assessments

donanemab DRUG

Administered IV

Also known as: LY3002813

Part B: Donanemab

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (27)

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

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

Irvine, California, 92697, United States

Location

Bradenton Research Center, Inc.

Bradenton, Florida, 34205, United States

Location

Merritt Island Medical Research, LLC

Merritt Island, Florida, 32952, United States

Location

Synexus Clinical Research US, Inc.

Orlando, Florida, 32806, United States

Location

Advanced Research Consultants

Palm Beach Gardens, Florida, 33410, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Intercoastal Medical Group - Hyde Park

Sarasota, Florida, 34239, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Josephson Wallack Munshower Neurology, PC

Indianapolis, Indiana, 46256, United States

Location

The University of Kansas - Clinical Research Center

Fairway, Kansas, 66205, United States

Location

Cotton O'Neil Clinical Research Center - Central Office

Topeka, Kansas, 66606, United States

Location

Boston Center for Memory

Newton, Massachusetts, 02459, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Las Vegas Medical Research

Las Vegas, Nevada, 89113, United States

Location

Advanced Memory Research Institute of New Jersey

Toms River, New Jersey, 08755, United States

Location

Guilford Neurologic Research, PA

Greensboro, North Carolina, 27405, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Neurology Diagnostics, Inc.

Dayton, Ohio, 45459, United States

Location

Abington Neurological Associates, Ltd.

Abington, Pennsylvania, 19001, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

National Clinical Research, Inc

Richmond, Virginia, 23294, United States

Location

Bruyère Research Institute

Ottawa, Ontario, K1N 5C8, Canada

Location

Toronto Memory Program

Toronto, Ontario, M3B 2S7, Canada

Location

Clinique de la Mémoire de l'Outaouais

Gatineau, Quebec, J8T 8J1, Canada

Location

Diex Recherche Sherbrooke Inc.

Sherbrooke, Quebec, J1L 0H8, Canada

Location

Related Links

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

MeSH Terms

Conditions

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

Interventions

donanemab

Condition Hierarchy (Ancestors)

Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 23, 2020
• Study Start: November 23, 2020
• Primary Completion: February 27, 2024
• Study Completion: February 27, 2024
• Last Updated: June 13, 2025
• Results First Posted: June 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

US (23); CA (4)