Clinical Trials in the UK / NCT06947941
Recruiting
Phase 3
A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)
NCT06947941 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Alzheimer DiseasePsychosis
Investigational drug(s) / intervention(s)
KarXT: Specified dose on specified days
KarX-EC: Specified dose on specified days
KarXT + KarX-EC Arm Matching Placebo: Specified dose on specified days
Study summary
The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.
Eligibility
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.
Primary outcome measure(s)
- Change From Baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) Score — Up to approximately Week 14
Trial sites (22)
| Facility | City | Region | Status |
|---|---|---|---|
| Gilbert Neurology Partners/CCT Research | Gilbert | Arizona | Recruiting |
| Inland Psychiatric Medical Group. | Chino | California | Recruiting |
| Local Institution - 0001 | Naples | Florida | Withdrawn |
| Local Institution - 1401 | Naples | Florida | Not Yet Recruiting |
| Local Institution - 0029 | Cleveland | Ohio | Not Yet Recruiting |
| Insight Clinical Trials LLC - Independence | Independence | Ohio | Recruiting |
| Local Institution - 0020 | Macquarie Park | New South Wales | Not Yet Recruiting |
| Local Institution - 0052 | Nedlands | Western Australia | Not Yet Recruiting |
| Local Institution - 0054 | Toronto | Ontario | Not Yet Recruiting |
| Local Institution - 0027 | Whitby | Ontario | Not Yet Recruiting |
| Local Institution - 0025 | Montreal | Quebec | Not Yet Recruiting |
| Local Institution - 0040 | Suita | Osaka | Not Yet Recruiting |
| Local Institution - 0035 | Nankoku-shi | Japan | Not Yet Recruiting |
| Local Institution - 0034 | Osaka | Japan | Not Yet Recruiting |
| Local Institution - 0005 | Exeter | Devon | Not Yet Recruiting |
| Local Institution - 0023 | London | England | Not Yet Recruiting |
| Local Institution - 0015 | Oxford | Oxfordshire | Withdrawn |
| Local Institution - 0009 | Chertsey | Surrey | Not Yet Recruiting |
| Local Institution - 0017 | Sheffield | Yorkshire and the Humber | Not Yet Recruiting |
| Local Institution - 0018 | Crowborough | United Kingdom | Withdrawn |
| Local Institution - 0024 | London | United Kingdom | Not Yet Recruiting |
| Local Institution - 0004 | Motherwell | United Kingdom | Not Yet Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06947941 on ClinicalTrials.gov ↗ ← All trials in the UK