NCT05980949 · Phase 3 · RECRUITING
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)
This trial is testing whether KarXT, a drug targeting certain brain receptors, is safe to take for up to a year in people who already have Alzheimer's-related psychosis. It is a Phase 3 open-label extension, meaning everyone gets the active drug and the main question is long-term safety and tolerability, not whether it works better than a placebo. Only people who completed one of three specific earlier KarXT studies can join.
Eligibility criteria
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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-07-06