A Study of KarXT for Psychosis Associated With Alzheimer's Disease (ADEPT-1)
This study is testing a drug called KarXT to see if it can help prevent psychosis (a mental health condition where a person loses touch with reality) in people with Alzheimer's disease. Researchers want to know if KarXT works better than a placebo (an inactive pill that looks like the study drug) and if it is safe. We are looking for 410 participants between 55 and 90 years old. The main goal is to see if KarXT can prevent psychosis from returning over 38 weeks. The study is currently recruiting participants.
- Study design
- This is a Phase 3, randomized, double-blind study involving 410 participants. This means participants will be randomly assigned to receive either KarXT or a placebo, and neither you nor your doctors will know which you are receiving.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will follow participants for 38 weeks to see if psychosis returns.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05511363
A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)
Recruiting
PHASE3Ages 55–90InterventionalTreatmentKaruna Therapeutics, Inc., a Bristol Myers Squibb company
~410 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:KarXTPlacebo
At a glance
Recruiting sites
36 of 129 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time from randomization to relapse
Measured over Week 38
Conditions
Where it's being run
129 sites across 45 statesFlorida31
Serbia10
New York8
Spain7
California6
City of Zagreb6
Bulgaria5
Czechia5
Study leadership
- Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Is aged 55 to 90 years, inclusive, at Screening
Can understand the nature of the study and protocol requirements and provide a signed informed consent form before any study assessments are performed. If the subject is deemed not competent to provide consent, the following requirements for consent must be met.
Meets clinical criteria for possible or probable Alzheimer's Disease
Has 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. If not available, a non-contrast brain MRI or non-contrast head CT must be done during screening.
Living at the same location for a minimum of 4 weeks before Screening, with the intention of living at the same location throughout the study.
Capable of self-locomotion (alone or with the aid of an assistive device) and have an identified caregiver or study partner who, in the investigator's judgment, has frequent and sufficient contact with the participant (ie, ≥ approximately 7 hours per week) on a regular basis to reliably provide accurate information regarding the participant's cognitive, behavioral, and functional status, and is willing to:
History of psychotic symptoms (meeting International Psychogeriatric Association \[IPA\] criteria) for at least 2 months prior to Screening.
Clinical Global Impressions-Severity (CGI-S) scale with a score ≥4 (moderate) at Screening and Baseline. CGI-S requires the assessor to consider aspects of the psychosis prior to providing a global assessment of severity. These aspects include hallucinations and delusions.
Subjects are required to meet at least one of the following criteria at Screening and Baseline:
Mini-Mental State Examination (MMSE) score of 6 to 24, inclusive, at Screening
If the subject is taking a cholinesterase inhibitor and/or memantine, they must have been on a stable dose for 6 weeks prior to Screening and be willing to maintain a stable dose for the duration of the study.
Participant is willing and able to attend the study visit for the study duration, follow instructions, and comply with the protocol requirements
BMI must be within 16 to 40 kg/m2 and participants with a BMI of 16 to \<18 kg/m2 must have a body weight ≥40 kg.
A female (as assigned at birth) is eligible to participate if she is not pregnant or breastfeeding. Individual of childbearing potential (IOCBP) must be able and willing to use at least 1 highly effective method of contraception during the study and for at least 1 menstrual cycle (e.g., 30 days) after the last dose of IMP.
Exclusion
Psychotic symptoms that are primarily attributable to a condition other than the Alzheimer's Disease causing dementia
History of major depressive episode with psychotic features during the 12 months prior to Screening
History of a diagnosis 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
Significant or severe renal impairment based on a screening cutoff for Estimated Glomerular Filtration Rate (eGFR) of \<50 mL/min
History of ischemic stroke within 12 months prior to Screening or any evidence of hemorrhagic stroke
History of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, unstable thyroid function, or unexplained syncope
Any of the following:
Myocardial infarction within the 6 months prior to Screening
Personal or family history of symptoms of long QT syndrome as evaluated by the investigator
Human immunodeficiency virus, cirrhosis, biliary duct abnormalities, active biliary disease, hepatobiliary carcinoma, and/or active hepatic viral infections as indicated by medical history or liver function tests results
History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the investigator
Participants with any of the following:
History of obstructive gastrointestinal disorder, gastric retention, irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months
Risk of suicidal behavior during the study as determined by clinical assessment and/ or C-SSRS
Clinically significant abnormal finding on the physical examination, electrocardiogram, or clinical laboratory results at Screening
Urine toxicology screen is positive substances other than cannabis or benzodiazepines (both cannabis and short-or medium-acting benzodiazepines are allowed in limited quantities during the study) unless approval has been given by the Medical Monitor
Currently receiving monoamine oxidase inhibitors, anticonvulsants (e.g., lamotrigine, divalproex), mood stabilizers (eg, lithium) tricyclic antidepressants (e.g., imipramine, desipramine), or any other psychoactive medications except for as-needed anxiolytics (e.g., lorazepam) and unable to complete the washout:
If, in the opinion of the Investigator and/or Sponsor/Medical Monitor, subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the Investigator and/or Sponsor/ Medical Monitor, may compromise the safety of the subject or affect his/her ability to adhere to the protocol visit schedule or fulfill visit requirements
Positive test for coronavirus (COVID-19) within 2 weeks before or at Screening; antigen or PCR local testing can be done at the discretion of the Investigator
Unable to taper and discontinue a concomitant medication that would preclude participation in the study
Prior exposure to KarXT
Experienced any significant adverse events due to trospium, including a known hypersensitivity 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 past year
What this trial measures
- Time from randomization to relapseWeek 38