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NCT04640077 · ClinicalTrials.gov registry record · Phase 2
A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)
A Phase 2 study of Alzheimer Disease and Dementia, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 95
- Enrollment target
- 20
- Study locations
NCT04640077: Completed Phase 2 study of Alzheimer Disease and Dementia, sponsored by Eli Lilly and Company.
NCT04640077 is a Phase 2 study of Alzheimer Disease and Dementia that has completed, run by Eli Lilly and Company. The registered enrollment target is 95 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04640077, a Phase 2 study of Alzheimer Disease and Dementia, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 95 participants
- Enrollment target
- 20
- Study locations
Study 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
Primary Outcome
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
Conditions Studied
Interventions
- OTHER No Intervention
- DRUG donanemab
Study Locations (20)
Florida
- Bradenton Research Center, Inc. - Bradenton
- Merritt Island Medical Research, LLC - Merritt Island
- Synexus Clinical Research US, Inc. - Orlando
- Advanced Research Consultants - Palm Beach Gardens
- Progressive Medical Research - Port Orange
- Intercoastal Medical Group - Hyde Park - Sarasota
- Stedman Clinical Trials - Tampa
Indiana
- Indiana University - Indianapolis
- Josephson Wallack Munshower Neurology, PC - Indianapolis
Kansas
- The University of Kansas - Clinical Research Center - Fairway
- Cotton O'Neil Clinical Research Center - Central Office - Topeka
Ohio
- Ohio State University - Columbus
- Neurology Diagnostics, Inc. - Dayton
Arizona
- Banner Alzheimer's Institute - Phoenix
California
- UC Irvine-Institute for Memory Impairments and Neurological Disorders (UCI MIND) - Irvine
Massachusetts
- Boston Center for Memory - Newton
Missouri
- Washington University - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2020-11-23 |
| Est. Completion | 2024-02-27 |
| Phase | Phase 2 |
What the finished NCT04640077 record still lists
NCT04640077 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (97% lower).
The record links to 5 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which No Intervention is the first listed.
NCT04640077 names 20 study sites across 11 states, led by Florida, Indiana, Kansas.
Frequently Asked Questions
What is clinical trial NCT04640077 about?
NCT04640077 is a clinical study titled "A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)". 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
What is the current status of trial NCT04640077?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2020-11-23. Estimated completion is 2024-02-27.
What conditions does trial NCT04640077 study?
This clinical trial studies the following conditions: Alzheimer Disease, Dementia, Cognitive Impairment, Central Nervous System Diseases, Brain Diseases.
What interventions are being tested in trial NCT04640077?
The interventions under investigation include: No Intervention (OTHER), donanemab (DRUG).
Who is sponsoring clinical trial NCT04640077?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04640077 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04640077's enrollment target sits among peer trials
95 157th of 306 higher than 149 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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