NCT04640077CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 13 Jun 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 95 (actual)
- First submitted
- 9 Nov 2020
- Start date
- 23 Nov 2020
- Primary completion date
- 27 Feb 2024
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Alzheimer disease
- NCT number
- NCT04640077
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 95
- From 23 Nov 2020 to the primary completion date, 27 Feb 2024
- 27 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Poor venous access
- Contraindication to PET or MRI imaging
Who the study is looking for
- 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
Age in the registry: 60 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinique de la Mémoire de l'Outaouais Coordinator of this site? Confirm its status | Gatineau | Canada | Unknown status |
| Bruyère Research Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Diex Recherche Sherbrooke Inc. Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
| Toronto Memory Program Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Abington Neurological Associates, Ltd Coordinator of this site? Confirm its status | Abington | United States | Unknown status |
| Bradenton Research Center, Inc. Coordinator of this site? Confirm its status | Bradenton | United States | Unknown status |
| Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Neurology Diagnostics, Inc. Coordinator of this site? Confirm its status | Dayton | United States | Unknown status |
| The University of Kansas - Clinical Research Center Coordinator of this site? Confirm its status | Fairway | United States | Unknown status |
| Guilford Neurologic Research, PA Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Josephson Wallack Munshower Neurology, PC Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| UC Irvine-Institute for Memory Impairments and Neurological Disorders (UCI MIND) Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| Las Vegas Medical Research Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Merritt Island Medical Research, LLC Coordinator of this site? Confirm its status | Merritt Island | United States | Unknown status |
| Boston Center for Memory Coordinator of this site? Confirm its status | Newton | United States | Unknown status |
| Synexus Clinical Research US, Inc. Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Advanced Research Consultants Coordinator of this site? Confirm its status | Palm Beach Gardens | United States | Unknown status |
| Banner Alzheimer's Institute Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Progressive Medical Research Coordinator of this site? Confirm its status | Port Orange | United States | Unknown status |
| Rhode Island Hospital Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| National Clinical Research, Inc Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Intercoastal Medical Group - Hyde Park Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Stedman Clinical Trials Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Advanced Memory Research Institute of New Jersey Coordinator of this site? Confirm its status | Toms River | United States | Unknown status |
| Cotton O'Neil Clinical Research Center - Central Office Coordinator of this site? Confirm its status | Topeka | United States | Unknown status |
Related publications
- Infusion-related reactions in donanemab-treated participants with early symptomatic Alzheimer's disease.Alzheimers Dement (N Y) · 2026 · PMID 41804324
This page is information, not medical advice. Discuss any trial with your doctor.