A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for the Treatment of Cognitive Impairment Associated with Mild to Moderate Alzheimer’s Disease (MINDSET 1)
Phase 3 – large-scale trial before approval
Conditions:
Mild to moderate Alzheimer’s Disease
Sponsor: Bristol-Myers Squibb Services Unlimited Company
trial.available_in:
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Overview
Trial status: Authorised
Change from baseline in ADCS-ADL at Week 24, Change from baseline in NPI total score at Week 24, Occurence of AEs and SAEs, AESIs, AEs leading to study intervention discontinuation, AEs leading to study discontinuation, and AEs leading to death through Week 24, Incidence and severity of clinically significant changes in vital signs, ECG, C-SSRS, weight, and safety laboratory tests through Week 24
Change from baseline in ADAS-Cog11 at Week 24, CIBIC+ at Week 24
Description
Change from baseline in ADCS-ADL at Week 24, Change from baseline in NPI total score at Week 24, Occurence of AEs and SAEs, AESIs, AEs leading to study intervention discontinuation, AEs leading to study discontinuation, and AEs leading to death through Week 24, Incidence and severity of clinically significant changes in vital signs, ECG, C-SSRS, weight, and safety laboratory tests through Week 24
Who can participate
Age group: 18-64 years, 65+ years
Gender: Female, Male
Target enrollment: 225 participants
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