KarXT for Alzheimer's-Associated Psychosis
(ADEPT-1 Trial)
Trial Summary
Do I need to stop my current medications to join the trial?
The trial requires that if you are taking a cholinesterase inhibitor or memantine, you must have been on a stable dose for 6 weeks before joining and continue that dose during the study. Some other medications, like certain antidepressants, need to be stable for at least 8 weeks before joining. You may need to stop or adjust other medications, so it's best to discuss with the trial team.
How is the drug KarXT different from other drugs for Alzheimer's-associated psychosis?
KarXT is unique because it combines two components, xanomeline and trospium chloride, which work together to target symptoms of Alzheimer's-associated psychosis. Unlike other treatments, it uses a novel mechanism by combining a muscarinic receptor agonist (xanomeline) with a peripheral muscarinic receptor antagonist (trospium chloride) to potentially reduce side effects while treating psychosis.12345
What is the purpose of this trial?
This trial is testing KarXT, a medication, to see if it can prevent psychotic symptoms from returning in people with Alzheimer's Disease. It works by balancing brain chemicals that cause hallucinations and delusions. KarXT has shown positive results in reducing symptoms of schizophrenia.
Research Team
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Eligibility Criteria
This trial is for people aged 55-90 with Alzheimer's-related psychosis, able to move independently (with or without aid), and have a caregiver. They must not be pregnant, agree to use contraception if applicable, and have been on stable doses of certain medications for six weeks. Exclusions include recent major depression with psychosis, stroke history within the last year, COVID-19 infection within two weeks before screening, or prior KarXT exposure.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either KarXT or placebo in a double-blind manner to evaluate relapse prevention in psychosis associated with Alzheimer's Disease
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- KarXT
- Placebo
KarXT is already approved in United States for the following indications:
- Schizophrenia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Karuna Therapeutics
Lead Sponsor