Psychosis in Alzheimer's Disease

(ADEPT-4 Trial)

Not currently recruiting at 214 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Karuna Therapeutics

Disqualifiers: Schizophrenia, Bipolar, Major depression, others

Compensation: Varies

Number of Visits: 8 in-clinic

Duration: 22 weeks

Trial Summary

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a study drug called KarXT for treating psychosis in people with Alzheimer's Disease. Participants will receive either investigational KarXT or a placebo (a pill with no active medicine) to compare results. The trial seeks adults diagnosed with Alzheimer's who have experienced psychotic symptoms for at least two months. These symptoms must not be caused by other conditions like schizophrenia.

Will the patient have to stop taking their current medications?

Some medications will need to be stopped, while others can be continued. Any changes to medication should be discussed with the trial coordinator or doctor.

Eligibility Criteria

Adults diagnosed with the Alzheimer's disease who are experiencing symptoms of psychosis may be eligible.

Inclusion Criteria

Has your loved one seen or heard things that others cannot see or hear (hallucinations)?

Exclusion Criteria

Has your loved one had a heart attack or serious cardiac event in the last 6 months?

Timeline

Screening

Participants are evaluated to confirm eligibility

Up to 4 weeks

Treatment

Participants receive the study treatment

14 weeks

Includes regular clinic visits and assessments

Follow-up

Participants are monitored for safety

4 weeks

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Collaborator

Headquarters

Princeton, NJ

Karuna, Inc., a Bristol Myers Squibb Company

Lead Sponsor

Headquarters

Boston, MA