A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alz… (NCT06126224) | Clinical Trial Compass
RecruitingPhase 3
A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)
United States, Belgium, Canada500 participantsStarted 2023-08-28
Plain-language summary
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
Age range
55 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score
Timeframe: Baseline and end of Treatment (up to 14 Weeks)
Trial details
NCT IDNCT06126224
SponsorKaruna Therapeutics, Inc., a Bristol Myers Squibb company
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2026-12-09
Contact for this trial
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
. 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.
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.