A Phase 3, Randomized, Double-Blind, Placebo-Controlled Relapse Prevention Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Summary
This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease. The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason or relapse and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.
Eligibility
- Age range
- 55–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Is aged 55 to 90 years, inclusive, at Screening * Can understand the nature of the study and protocol requirements and provide a signed informed consent form before any study assessments are performed. If the subject is deemed not competent to provide consent, the following requirements for consent must be met. i) The subject's legally acceptable representative must provide informed consent; ii) The subject must provide informed consent. * Meets clinical criteria for possible or probable Alzheimer's Disease * Has a Magnetic Resonance Imaging (MRI) or Computed Tomograp…
Interventions
- DrugKarXT
KarXT 20 mg/2 mg TID KarXT 30 mg/3 mg TID KarXT 40 mg/4 mg TID KarXT 50 mg/5 mg TID KarXT 66.7/6.67 mg TID
- DrugPlacebo
Placebo Capsules
Locations (116)
- Local Institution - 1029Homewood, Alabama
- Local Institution - 1044Phoenix, Arizona
- Local Institution - 1033Encino, California
- Local Institution - 1031Irvine, California
- ATP Clinical Research-302 W La Veta AveOrange, California
- Local Institution - 1043Pasadena, California