What is KarXT studying for psychosis associated with Alzheimer's disease?

KarXT is being studied along with KarX-EC to evaluate their safety and effectiveness in treating psychosis symptoms, such as hallucinations and delusions, in people with Alzheimer's disease. This research helps understand if these drugs can manage these challenging symptoms. The study is sponsored by Bristol-Myers Squibb.

Who may be eligible for this Alzheimer's disease clinical trial?

Adults aged 55 to 90 years diagnosed with Alzheimer's disease and experiencing psychotic symptoms for at least 2 months may be eligible. Participants must have had a recent brain scan to rule out other causes of dementia. The trial accepts all genders and excludes those with psychosis from other conditions. Please review eligibility criteria for more details.

Is there any cost to participate in this Alzheimer's disease clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. Personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 3

Age: 55Years - 90Years

All Genders

ID06947941

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of KarXT KarX-EC for Psychosis Associated with Alzheimers Disease

Led by Bristol-Myers Squibb · Updated on 2026-06-02

325

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the combination of KarXT and KarX-EC as a treatment for psychosis linked to Alzheimers disease in adults aged 55 to 90. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the safety and effectiveness of these drugs in managing symptoms such as hallucinations and delusions related to this condition. Participants will be assigned to receive either the KarXT plus KarX-EC treatment or a matching placebo, with specified doses given on certain days over approximately 14 weeks. The study will monitor changes in neuropsychiatric symptoms, agitation, and caregiver distress, along with safety measures including adverse events and laboratory tests. During the trial, participants will undergo various evaluations such as neuropsychiatric inventories, clinical global impressions, cognitive assessments, and safety monitoring through lab tests, vital signs, and symptom tracking. The primary outcome focuses on changes in hallucinations and delusions up to week 14, with ongoing review of additional cognitive and safety outcomes throughout the study period.

CONDITIONS

Brief Title

A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)

Who Can Participate

Age: 55Years - 90Years

All Genders

Eligibility Criteria

You may qualify if you...

Participants must be 55 to 90 years old at screening.
Diagnosed with Alzheimer's disease according to the 2024 revised criteria.
Have a brain MRI or CT scan from within the past 5 years to exclude other CNS diseases.
History of psychotic symptoms meeting specific criteria for at least 2 months before screening.

You will not qualify if you...

Psychotic symptoms primarily caused by conditions other than Alzheimer's disease, such as schizophrenia or mood disorders.
History of major depressive episode with psychotic features in the past 12 months.
History of bipolar disorder, schizophrenia, or schizoaffective disorder.
Certain safety concerns including specific abnormal laboratory tests.
Other protocol-defined inclusion/exclusion criteria.

Research Team

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com

First line of the email MUST contain NCT # and Site #.

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