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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated with Alzheimer’s Disease (ADEPT-2)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504416-16-00
Acronym
KAR-032
Enrollment
186
Registered
2024-02-21
Start date
2024-04-11
Completion date
Unknown
Last updated
2025-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychosis Associated with Alzheimer’s Disease

Brief summary

Change in NPI-C: H+D score

Detailed description

•Change in the CGI-S scale: CGI-S requires the assessor to consider aspects of the psychosis (hallucinations and delusions) prior to providing a global assessment of severity, •Change in the: - NPI-C Core score: hallucinations, delusions, agitation, and aggression domains - NPI-C: Agitation score - NPI-C Core score: Caregiver Distress scale (Hallucinations, Delusions, Agitation, and Aggression domains), •Responder rate defined as NPI-C: H+D score ≥ 40% improvement - Change in CMAI-IPA score - Change in CMAI Total score

Interventions

None listed

Sponsors

Karuna Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in NPI-C: H+D score

Secondary

MeasureTime frame
•Change in the CGI-S scale: CGI-S requires the assessor to consider aspects of the psychosis (hallucinations and delusions) prior to providing a global assessment of severity, •Change in the: - NPI-C Core score: hallucinations, delusions, agitation, and aggression domains - NPI-C: Agitation score - NPI-C Core score: Caregiver Distress scale (Hallucinations, Delusions, Agitation, and Aggression domains), •Responder rate defined as NPI-C: H+D score ≥ 40% improvement - Change in CMAI-IPA score - Change in CMAI Total score

Countries

Belgium, Greece, Hungary, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026