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KarXT for Psychosis in Alzheimer's Disease (ADEPT-4 Trial)

Phase 3
Recruiting
Research Sponsored by Karuna Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1)
Be older than 18 years old
Must not have
History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder
Patients will not be able to participate if they have psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

This trial aims to test the safety and effectiveness of KarXT in adults with Alzheimer's Disease who also have psychosis.

Who is the study for?
This trial is for adults with mild to severe Alzheimer's Disease who also have moderate to severe psychosis related to their condition. Specific eligibility details are not provided, but typically participants must meet certain health criteria and not be on conflicting medications.
What is being tested?
The study is testing KarXT against a placebo to see if it's safe and effective in treating psychosis symptoms in Alzheimer's patients. Participants will randomly receive either the actual medication or a placebo for comparison.
What are the potential side effects?
While specific side effects of KarXT are not listed here, common ones may include dizziness, nausea, sleep disturbances, or changes in appetite. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 55 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had a major depressive episode with psychosis or been diagnosed with bipolar, schizophrenia, or schizoaffective disorder in the last year.
Select...
My dementia is not due to schizophrenia or similar conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Group II: KarXTExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Karuna TherapeuticsLead Sponsor
16 Previous Clinical Trials
3,628 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,582 Previous Clinical Trials
3,388,195 Total Patients Enrolled
~271 spots leftby Oct 2026
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