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Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects with Psychosis Associated with Alzheimer’s Disease (ADEPT-3)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504151-27-00
Acronym
KAR-033
Enrollment
289
Registered
2024-02-05
Start date
2024-05-09
Completion date
Unknown
Last updated
2025-10-31

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

Incidence of TEAEs

Detailed description

Incidence of serious TEAEs Incidence of TEAEs leading to discontinuation of IMP

Interventions

DRUGKarXT

Sponsors

Karuna Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence of TEAEs

Secondary

MeasureTime frame
Incidence of serious TEAEs Incidence of TEAEs leading to discontinuation of IMP

Countries

Belgium, Bulgaria, Croatia, Czechia, France, Germany, Greece, Hungary, Italy, Poland, Portugal, Romania, Slovakia, Spain

Outcome results

None listed

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