KarXT for Psychosis Associated With Alzheimer's Disease
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)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
55 – 90
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,000 (estimated)
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Industry
Who this trial is looking for
This trial is looking for people who have completed previous studies on KarXT for Alzheimer's-related psychosis. Participants will take KarXT for a year to help researchers understand its long-term safety and tolerability.
Are You a Good Fit for This Trial?
You may be able to join if
I have completed a previous study on KarXT.
I can understand the study and give my consent.
I have a stable living environment.
You may not be able to join if
I have significant medical conditions that my doctor thinks could affect my safety.
I have serious health issues found in tests at my last study visit.
I am taking part in another clinical study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 sa…
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.
Trial Locations
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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 …
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.
Contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
First line of the email MUST contain NCT # and Site #.
CONTACT
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