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RecruitingPhase 3

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)

Asset

Xanomeline / trospium

Listed sites

429

Recruiting sites

127

Enrollment

1,000

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Age 55-90

Primary endpoint

•Treatment-emergent adverse events (TEAEs)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Secondary ID2023-504151-27EU CTR
Org study IDCN012-0028
Secondary IDCN012-0028Bristol-Myers Squibb Protocol ID
Secondary IDKAR-033Karuna Pharmaceuticals Protocol ID
NCT IDNCT05980949

Timeline

Milestones

Study start2023-07-11actual
Study first posted2023-08-08actual
Last update posted2026-07-06actual
Primary completion2027-09-07estimated
Study completion2027-09-07estimated

Assets

Drug assets

Xanomeline / trospium

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Must have completed study KAR-031 (CN012-0026), KAR-032(CN012-0027), or CN012-0056. This Inclusion criterion is not applicable for Protocol Amendment 07 or later versions.
•Can understand the nature of the study and protocol requirements and provide a signed informed consent (IC) form before any study assessments are performed. If the subject is deemed not competent to provide IC, both the following requirements for consent must be met:

1. The subject's legally acceptable representative (LAR) must provide IC

2. The subject must provide informed assent

•Must have stable living environment. At entry into this study, or any time during the study, if a subject needs to relocate from home, a residential assisted-living facility, or other stable location to a nursing home facility, the Sponsor/Medical Monitor must approve the subject's participation in the study

Exclusion criteria

•Significant or severe medical conditions 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.
•Clinically significant abnormalities, including any finding(s) from the ECG, laboratory tests, physical examination, or vital signs, at the EOT visit of Study KAR-031 (Visit 19), Study KAR-032 (Visit 12), Study CN012-0056 (Visit 12) that the Investigator, in consultation with the Medical Monitor, are considered to jeopardize the safety of the subject.
•Subjects participating in another investigational drug or device study or planning on participating in another clinical study during the duration of KAR-033.
•Other protocol-defined Inclusion/Exclusion criteria apply.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
2
Safety / tolerability / PK
1

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Incidence of treatment-emergent adverse events (TEAEs)

Time frame:From initial dose through 14 days after the final dose (up to 54 weeks)

threshold achievement, event

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Incidence of serious TEAEs

Time frame:From initial dose through 14 days after the final dose (up to 54 weeks)

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Incidence of TEAEs leading to withdrawal

Time frame:From initial dose through 14 days after the final dose (up to 54 weeks)

threshold achievement, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.