RightFit
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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the long-term safety of KarXT and how well people can tolerate it over 52 weeks. It is for people with Alzheimer's disease and psychosis, which can mean seeing or hearing things that are not there or believing things that are not true.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Must have finished study KAR-031 (CN012-0026), KAR-032 (CN012-0027), or CN012-0056. This rule does not apply under study plan update 07 or later.
  • Must understand the study and sign a consent form before any study tests. If you cannot give consent, your legal representative must give consent, and you must agree to take part.
  • Must have a stable place to live. If you need to move to a nursing home when joining or during the study, the sponsor or study medical monitor must approve your participation.

Who can't join

  • A serious health problem that the study doctor thinks could make the study unsafe, keep you from following or finishing it, or affect the results.
  • Test results at the final visit of a prior study that the study doctor and medical monitor think could make participation unsafe. These include heart tracing (ECG), lab tests, a physical exam, or vital signs such as blood pressure.
  • Taking part in another study of an experimental drug or device, or planning to join another clinical study during this study.
  • Other rules in the study plan also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (148)

AL

AZ

CA

CO

CT

FL

GA

IL

LA

MA

MI

MO

MS

NC

NJ

NY

OH

OK

RI

SC

TN

TX

VA

WA