Recruiting NCT06947941
A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KarXT, KarX-EC, KarXT + KarX-EC Arm Matching Placebo.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease, Psychosis. Basic parameters: 55 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada, Japan, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Psychosis Associated With Alzheimer's Disease
Overview
The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.
Interventions
- Drug KarXT
Specified dose on specified days - Drug KarX-EC
Specified dose on specified days - Drug KarXT + KarX-EC Arm Matching Placebo
Specified dose on specified days
Primary outcome measures
- Change From Baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) Score [Time frame: Up to approximately Week 14]
Secondary outcome measures (12)
- Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score [Time frame: Up to approximately Week 14]
- Change From Baseline in Neuropsychiatric Inventory-Clinician Rating Scale (NPI-C) Core Score [Time frame: Up to approximately Week 14]
- Change From Baseline in NPI-C: Agitation Score [Time frame: Up to approximately Week 14]
- Change From Baseline in NPI-C Core Score: Caregiver Distress Scale [Time frame: Up to approximately Week 14]
- Responder Rate [Time frame: Up to approximately Week 14]
- Change From Baseline in Cohen-Mansfield Agitation Inventory International Psychogeriatric Association (CMAI-IPA) Score [Time frame: Up to approximately Week 14]
- Change From Baseline in CMAI Total Score [Time frame: Up to approximately Week 14]
- Number of Participants With Adverse Events (AEs) [Time frame: Up to approximately Week 14]
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to approximately Week 14]
- Number of Participants With Serious Adverse Events (SAEs) [Time frame: Up to approximately Week 14]
- Number of Participants With TEAEs Leading to Discontinuation [Time frame: Up to approximately Week 14]
- Number of Participants With Spontaneously Reported Procholinergic Symptoms [Time frame: Up to approximately Week 14]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United Kingdom · 8 centers
- Local Institution - 0005 — Exeter
- Local Institution - 0023 — London
- Local Institution - 0015 — Oxford
- Local Institution - 0009 — Chertsey
- Local Institution - 0017 — Sheffield
- Local Institution - 0018 — Crowborough
- Local Institution - 0024 — London
- Local Institution - 0004 — Motherwell
United States · 6 centers
- Gilbert Neurology Partners/CCT Research — Gilbert
- Inland Psychiatric Medical Group. — Chino
- Local Institution - 0001 — Naples
- Local Institution - 1401 — Naples
- Local Institution - 0029 — Cleveland
- Insight Clinical Trials LLC - Independence — Independence
Canada · 3 centers
- Local Institution - 0054 — Toronto
- Local Institution - 0027 — Whitby
- Local Institution - 0025 — Montreal
Japan · 3 centers
- Local Institution - 0040 — Suita
- Local Institution - 0035 — Nankoku-shi
- Local Institution - 0034 — Osaka
Australia · 2 centers
- Local Institution - 0020 — Macquarie Park
- Local Institution - 0052 — Nedlands
Identifiers
NCT: NCT06947941 · CN012-0034 · 2025-521057-16 · U1111-1318-5718