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NCT03887455 · ClinicalTrials.gov registry record · Phase 3
A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease
A Phase 3 study of Early Alzheimer's Disease, sponsored by Eisai.
- Active
- Registry status
- Phase 3
- Development phase
- 1,906
- Enrollment target
- 20
- Study locations
NCT03887455: Active Phase 3 study of Early Alzheimer's Disease, sponsored by Eisai.
NCT03887455 is a Phase 3 study of Early Alzheimer's Disease that is active but no longer recruiting, run by Eisai. The registered enrollment target is 1,906 participants, above the 830-participant average among 7 other Early Alzheimer's Disease trials with a reported enrollment target (130% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03887455, a Phase 3 study of Early Alzheimer's Disease, is active but no longer recruiting, sponsored by Eisai.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,906 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of lecanemab in participants with EAD in the Extension Phase and whether the long-term effects of lecanemab as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase. Extension Phase Part B will continue dosing with lecanemab in countries where lecanemab may not be commercially available.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lecanemab IV
- DRUG Lecanemab SC
Study Locations (20)
California
- Neurology Center of North Orange County - Fullerton
- Irvine Clinical Research - Irvine
- University of California - Los Angeles - Los Angeles
- Pacific Neuroscience Medical Group - Oxnard
- Stanford University Medical Center - Palo Alto
- Pacific Research Network, Inc - San Diego
- Sharp Mesa Vista Hospital - San Diego
- UCSF Memory and Aging Center - San Francisco
- Apex Research Institute - Santa Ana
- St Joseph Heritage Healthcare - Santa Rosa
- North Bay Neuroscience Research Institute - Sebastopol
Connecticut
- Associated Neurologists of Southern Connecticut - Fairfield
- Institute for Neurodegenerative Disorders - New Haven
- Yale University School Of Medicine - New Haven
- Research Center for Clinical Studies, Inc. - Norwalk
Arizona
- Banner Alzheimer's Institute- Clinical Trials Department - Phoenix
- Banner Sun Health Research - Sun City
- Neurological Associates of Tucson dba Center for Neurosciences - Tucson
Colorado
- ImmunoE Research Center - Centennial
- Mile High Research Center - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,906 participants |
| Start Date | 2019-03-27 |
| Est. Completion | 2029-06-30 |
| Phase | Phase 3 |
What the registry record for NCT03887455 still lists
NCT03887455 is an interventional study that assigns participants to a tested intervention. Its 1,906 participants enrollment target places it among the larger protocols in the corpus, above the 830-participant average among 7 other Early Alzheimer's Disease trials with a reported enrollment target (130% higher).
The record links to 1 condition, with Early Alzheimer's Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03887455 names 20 study sites across 4 states, led by California, Connecticut, Arizona.
Frequently Asked Questions
What is clinical trial NCT03887455 about?
NCT03887455 is a clinical study titled "A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease". This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the...
What is the current status of trial NCT03887455?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,906 participants. The study started on 2019-03-27. Estimated completion is 2029-06-30.
What conditions does trial NCT03887455 study?
This clinical trial studies the following conditions: Early Alzheimer's Disease.
What interventions are being tested in trial NCT03887455?
The interventions under investigation include: Placebo (DRUG), Lecanemab IV (DRUG), Lecanemab SC (DRUG).
Who is sponsoring clinical trial NCT03887455?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03887455 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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