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A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects 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 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.
All administrations of study drug will be administered in the clinic or in the home; However, home administrations of intravenous (IV) study drug will be allowed per sponsor approval according to country and local guidelines during the COVID-19 pandemic and following its resolution, where permitted.
Age
50 - 90 years
Sex
ALL
Healthy Volunteers
No
Banner Alzheimer's Institute- Clinical Trials Department
Phoenix, Arizona, United States
Banner Sun Health Research
Sun City, Arizona, United States
Neurological Associates of Tucson dba Center for Neurosciences
Tucson, Arizona, United States
Neurology Center of North Orange County
Fullerton, California, United States
Irvine Clinical Research
Irvine, California, United States
University of California - Los Angeles
Los Angeles, California, United States
Pacific Neuroscience Medical Group
Oxnard, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Pacific Research Network, Inc
San Diego, California, United States
Sharp Mesa Vista Hospital
San Diego, California, United States
Start Date
March 27, 2019
Primary Completion Date
June 30, 2029
Completion Date
June 30, 2029
Last Updated
October 14, 2025
1,906
ACTUAL participants
Lecanemab IV
DRUG
Placebo
DRUG
Lecanemab SC
DRUG
Lead Sponsor
Eisai Inc.
Collaborators
NCT07033494
NCT04599764
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04693520