NCT05980949 · Karuna Therapeutics
Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT and KarXT + KarX-EC in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)
What this study is about
This is a Phase 3 global, conducted at multiple hospitals, 52-week, where both patients and doctors know the treatment given extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027, CN012-0056 or CN012-0034.
View original scientific description
This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027, CN012-0056 or CN012-0034. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study, 14-week CN012-0056 or 14 week CN012-0034 study will be eligible to enroll in CN012-0028.
Interventions
DRUG
KarXT
KarXT 20/2 mg TID (total daily dose \[TDD\] 60/6 mg) KarXT 30/3 mg TID (TDD 90/9 mg) KarXT 40/4 mg TID (TDD 120/12 mg) KarXT 50/5 mg TID (TDD 150/15 mg) KarXT 66.7/6.67 mg TID (TDD 200/20 mg)
Primary outcome measures
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: From initial dose through 14 days after the final dose (up to 54 weeks)
The number and percentage of participants with TEAEs will be determined
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Must have completed study CN012-0026, CN012-0027, CN012-0034 or CN012-0056.
- Subject was aged 55 to 90 years, inclusive, at the time of enrollment into the parent CN012-0026, CN012-0027, CN012-0034 or CN012-0056 study.
- Can understand the nature of the study and protocol requirements and provide a signed informed consent or, if deemed not competent to provide informed consent, the subject's legally acceptable representative must provide informed consent, and the subject must provide informed assent before any study assessments are performed.
- At entry into this study, or any time during the study, if a subject needs to relocate from home or residential assisted-living facility to a nursing home facility, the Sponsor/Medical Monitor must approve the subject's participation in the study.
- Have an identified or proxy caregiver (spends approximately 10 hours/week with the subject).
Exclusion criteria
- Significant or severe medical conditions that, in the opin
Where
- Homewood, Alabama
- Chandler, Arizona
- Gilbert, Arizona
- Phoenix, Arizona
- Scottsdale, Arizona
- Anaheim, California
- Chino, California
- Costa Mesa, California
- Encino, California
- Irvine, California
- Lancaster, California
- Long Beach, California
And 83 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations