A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)

Recruiting Phase 3 Interventional Study
Psychosis Associated With Alzheimer's Disease
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
55 – 90
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
500 (estimated)
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Industry
Who this trial is looking for

This trial is looking for men and women aged 55 to 90 who have Alzheimer's disease along with symptoms like hallucinations or delusions. They need to have a stable living situation and a trusted person who sees them regularly. However, people with certain other mental health conditions or serious medical issues will not be eligible to participate.

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About This Trial
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of …
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria: 1. Is a male or female aged 55 to 90 years, inclusive, at Screening. 2. Can understand the nature of the trial and protocol requirements and provide informed consent or assent before any study assessments are performed. 3. Meets clinical criteria for Possible AD or Probable …
Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286

Clinical.Trials@bms.com

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