A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)
Bristol-Myers Squibb · NCT06947941
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 55–90 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 325
- US sites recruiting
- 3
- Study start
- March 25, 2026
- Record last updated
- June 30, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.
Being studied: KarXT; KarX-EC; KarXT + KarX-EC Arm Matching Placebo
Conditions: Alzheimer Disease; Psychosis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Participants must be 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
- Participants must be diagnosed with Alzheimer's disease in accordance with the 2024 revised criteria for diagnosis and staging of Alzheimer's Disease: Alzheimer's Association Workgroup.
- Participants 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, eg, major stroke, neoplasm, subdural hematoma.
- Participants must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation).
Exclusion Criteria
- Participants must not have psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features.
- Participants must not have history of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.
- Participants must not have certain safety concerns, including certain laboratory test irregularities.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Recruiting US locations
Gilbert Neurology Partners/CCT Research
Gilbert, AZ 85297
Site contact: Jonathan Hodgson, Site 0042 · 602-761-9631
Inland Psychiatric Medical Group.
Chino, CA 91710
Site contact: Nandita Puchakayala, Site 0031 · 909-488-9116
Insight Clinical Trials LLC - Independence
Independence, OH 44131
Site contact: Mark Stillman, Site 0043 · 216-444-8897
Study contacts (from the official record)
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com · 855-907-3286 · Clinical.Trials@bms.com
- First line of the email MUST contain NCT # and Site #.
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