Status:
ACTIVE_NOT_RECRUITING
A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)
Lead Sponsor:
Karuna Therapeutics
Conditions:
Psychosis Associated With Alzheimer's Disease
Eligibility:
All Genders
55-90 years
Phase:
PHASE3
Brief Summary
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild...
Eligibility Criteria
Inclusion
- Key
- Is a male or female aged 55 to 90 years, inclusive, at Screening.
- Can understand the nature of the trial and protocol requirements and provide informed consent or assent before any study assessments are performed.
- Meets clinical criteria for Possible AD or Probable AD.
- Living at the same home or residential assisted-living facility for a minimum of 6 weeks before Screening.
- Have an identified study partner who should have daily contact (approximately 10 hours a week or more).
- History of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months prior to Screening.
- CGI-S scale with a score ≥ 4 at Screening and Baseline.
- AD subjects are required to have NPI-C: Hallucinations and Delusions (H+D) score of ≥ 6 AND meet at least 1 of the following criteria at Screening and Baseline:
- Moderate to severe delusions, defined as NPI-C: Delusions domain score of ≥ 2 on 2 of the 8 items OR
- Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on 2 of the 7 items
- MMSE score of 8 to 22, inclusive, at Screening.
- Key
Exclusion
- Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia.
- History of major depressive episode with psychotic features during the 12 months prior to Screening.
- History of bipolar disorder, schizophrenia, or schizoaffective disorder.
- Significant or severe medical conditions including pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, cardiovascular, or oncologic disease or any other condition that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results.
- History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.
- Prior exposure to KarXT.
- History of hypersensitivity to KarXT excipients or trospium chloride.
- Experienced any significant adverse events (AEs) due to trospium.
- Participation in another clinical study in which the subject received an experimental or investigational drug within 3 months before Screening or has participated in more than 2 clinical studies in the 12 months prior to Screening.
Key Trial Info
Start Date :
August 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06126224
Start Date
August 28 2023
End Date
July 31 2025
Last Update
March 25 2025
Active Locations (119)
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1
Local Institution - 1116
Chandler, Arizona, United States, 85286
2
Local Institution - 1044
Phoenix, Arizona, United States, 85012-2836
3
Local Institution - 1104
Anaheim, California, United States, 92805-5854
4
Local Institution - 1119
Canoga Park, California, United States, 91303-1844