A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)

Recruiting Phase 3 Interventional Study
Alzheimer Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. 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
406 (estimated)
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Industry
Who this trial is looking for

This trial is looking for adults aged 55 to 90 who have been diagnosed with Alzheimer's disease and have experienced troubling symptoms like hallucinations or delusions for at least two months. However, if someone has severe mental health issues like schizophrenia or major depression with psychosis, they won’t be eligible to join. They also need to have had a brain scan in the last five years to ensure there aren’t other serious conditions affecting their symptoms.

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About This Trial

The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.

Trial Locations
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Eligibility Criteria
Inclusion Criteria * Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1). * Patients who are diagnosed with AD based on the 2024 revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup. * Patient must have a magnetic resonance imaging (M…
Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286

Clinical.Trials@bms.com

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