CN012-0025: A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated with Alzheimer’s Disease (ADAGIO-3)
Phase 3 – large-scale trial before approval
Conditions:
Agitation Associated with Alzheimer’s Disease
Sponsor: Bristol-Myers Squibb Services Unlimited Company
trial.available_in:
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Overview
Trial status: Authorised
Reported adverse events (AEs), TEAEs, serious AEs, and TEAEs leading to study withdrawal and deaths, AEs of special interest, Assessment of abnormal involuntary movements or restlessness, Body weight, Blood pressure and heart rate, Laboratory evaluations, Suicidal ideation, Assessment of cognition, Assessment of urinary retention.
Incidence of any Treatment-Emergent Adverse Events (TEAEs).
Description
Reported adverse events (AEs), TEAEs, serious AEs, and TEAEs leading to study withdrawal and deaths, AEs of special interest, Assessment of abnormal involuntary movements or restlessness, Body weight, Blood pressure and heart rate, Laboratory evaluations, Suicidal ideation, Assessment of cognition, Assessment of urinary retention.
Who can participate
Age group: 65+ years, 18-64 years
Gender: Female, Male
Target enrollment: 193 participants
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