A Randomized, Double-Blind, Placebo controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of JNJ-63733657, an anti-tau Monoclonal Antibody, in Participants with Early Alzheimer's Disease
What is the purpose of this trial?
Alzheimer's disease (AD) is a fatal neurodegenerative disease that is manifested by progressive cognitive deficits including memory loss followed by loss of independent function as well as neuropsychiatric symptoms such as apathy, depression, anxiety, agitation and psychosis. JNJ-63733657 is a humanized monoclonal anti-tau antibody which binds to phosphorylated tau (P-tau). The study will evaluate whether JNJ-63733657 can slow clinical (cognitive and functional) decline in participants with Early AD with evidence of elevated brain tau (T+) and assess its safety and tolerability. The study consists of: screening period (13 weeks), double-blind treatment period (up to 232 weeks), and a follow-up period (13 weeks). Safety and tolerability assessments will include adverse events (AEs), vital signs, electrocardiogram (ECG), early discontinuations, physical and neurological examinations, safety laboratory evaluations, suicidality risks (Columbia Suicide Severity Rating Scale [CSSRS]) and brain MRI will be performed during the study. The maximum treatment duration is up to 232 weeks (4.5 years).
- Ages55 years - 80 years
- Trial withJanssen Research & Development, LLC
- Start Date09/20/2021
- End Date01/08/2025
- Last Updated11/03/2021
- Study HIC#2000029685