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Clinical Trial ● Currently Recruiting Phase III NCT06947941

A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer’s Disease (ADEPT-5)

A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer’s Disease (ADEPT-5) — Recruiting • Phase III • Neurology…

📅 21 Apr 2026 ⏱ 2 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase III
NCT ID
NCT06947941
Sponsor
Bristol-Myers Squibb
Start
2026-03-25
ClinicaliQ Trial Snapshot
  • A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer’s Disease (ADEPT-5) — Recruiting • Phase III • Neurology • NCT06947941.
  • Treatment being tested: KarXT + KarX-EC combination therapy, a novel muscarinic M1/M4 receptor agonist approach, being evaluated specifically for psychosis symptoms in Alzheimer's disease patients.
  • Patient eligibility overview: Study recruits individuals with Alzheimer's disease who are experiencing psychotic symptoms (such as hallucinations or delusions), meeting diagnostic criteria for both conditions.
Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.

Eligibility Snapshot
  • : * 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).

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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