NCT06126224 · Karuna Therapeutics, Inc., a Bristol Myers Squibb company
A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)
What this study is about
This is a Phase 3, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment, parallel group study to evaluate the safety and effectiveness of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.
View original scientific description
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.
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
- Is a male or female aged 55 to 90 years, inclusive, at Screening.
- Can understand the nature of the trial and protocol requirements and provide informed consent or assent before any study assessments are performed.
- Meets clinical criteria for Possible AD or Probable AD.
- Must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, e.g., major stroke, neoplasm, subdural hematoma. If not available, a non-contrast brain MRI or non-contrast head CT must be done during Screening.
- Living at the same home or residential assisted-living facility for a minimum of 6 weeks before Screening.
- Have an identified study partner who should have daily contact (approximately 10 hours a week or more).
- History of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months prior to Screening.
- CGI-S scale with a score ≥ 4 at Screening and Baseline.
- AD subjects are required to have NPI-C: Hallucinations and Delusions (H+D) score of ≥ 6 AND meet at least 1 of the following criteria at Screening and Baseline:
- Moderate to severe delusions, defined as NPI-C: Delusions domain score of ≥ 2 on 2 of the 8 items OR
- Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on 2 of the 7 items
- MMSE score of 8 to 22, inclusive, at Screening. Key
Exclusion criteria
- Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia.
- History of major depressive episode with psychotic features during the 12 months prior to Screening.
- History of bipolar disorder, schizophrenia, or schizoaffective disorder.
- Significant or severe medical conditions including pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, cardiovascular, or oncologic disease or any other condition 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.
- History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.
- Prior exposure to KarXT.
- History of hypersensitivity to KarXT excipients or trospium chloride.
- Experienced any significant adverse events (AEs) due to trospium.
- Participation in another clinical study in which the subject received an experimental or investigational drug within 3 months before Screening or has participated in more than 2 clinical studies in the 12 months prior to Screening.
- Other protocol-defined inclusion/exclusion criteria may apply.
Where
- Chandler, Arizona
- Phoenix, Arizona
- Anaheim, California
- Canoga Park, California
- Encino, California
- Lancaster, California
- Los Alamitos, California
- Sherman Oaks, California
- Walnut Creek, California
- Apopka, Florida
- Clermont, Florida
- Cutler Bay, Florida
And 34 more locations — see the full list below.
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 Jun 16, 2026 · Source of record for eligibility and locations