Long-Term Safety Study of KarXT for Psychosis in Alzheimer's Disease
Tests KarXT, a long-term safety study in people with Alzheimer's-related psychosis.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Buenos Aires, Ciudad Autónoma de Buenos Aires, Córdoba, and Rosario, ArgentinaSee the 9 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 90 years old?
- Has a doctor told you that you have Alzheimer's disease?
- Do you have hallucinations or delusions caused by Alzheimer's disease?
Source: NCT05980949, who can take part
Where in Argentina
- Buenos AiresBuenos Aires, ArgentinaNot yet recruiting
- Buenos AiresBuenos Aires, ArgentinaNot yet recruiting
- Organización Médica de InvestigaciónBuenos Aires, ArgentinaTaking people
- Ciudad Autónoma de Buenos AiresCiudad Autónoma de Buenos Aires, ArgentinaNot yet recruiting
- Ciudad Autónoma de Buenos AiresCiudad Autónoma de Buenos Aires, ArgentinaNot yet recruiting
- Ciudad Autónoma de Buenos AiresCiudad Autónoma de Buenos Aires, ArgentinaNot yet recruiting
- CórdobaCórdoba, ArgentinaNot yet recruiting
- CórdobaCórdoba, ArgentinaNot yet recruiting
- RosarioRosario, ArgentinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- Trial code
- NCT05980949EU 2023-504151-27-00
- Record updated
- 16 October 2026
- Original description
This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.Read full original descriptionShow less
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 is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.
Inclusion: 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:; The subject's legally acceptable representative (LAR) must provide IC; 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: Subjects participating in another investigational drug or device study or planning on participating in another clinical study during the duration of KAR-033; 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; Other protocol-defined Inclusion/Exclusion criteria apply.