ClinicaliQ Trial Snapshot
- A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer’s Disease (ADEPT-2) — Recruiting • Phase III • Respiratory / COPD / Asthma • NCT06126224.
- Treatment being tested: KarXT, a novel muscarinic M1/M4 receptor agonist, is being evaluated for treating psychosis (including hallucinations, delusions, and agitation) in patients with Alzheimer's disease, representing a potentially new pharmacological approach to a common and challenging AD complication.
- Patient eligibility overview: The trial enrolls adults aged 55–90 years with confirmed mild to severe Alzheimer's disease who are experiencing active psychotic symptoms, providing a representative sample across the AD disease spectrum.
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
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.
Eligibility Snapshot
- Key Inclusion Criteria: 1. Is a male or female aged 55 to 90 years, inclusive, at Screening. 2. Can understand the nature of the trial and protocol requirements and provide informed consent or assent before any study assessments are performed. 3. Meets clinical criteria for Possible AD or Probable AD. 4. 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, e.g., major stroke, neoplasm, subdural hematoma. If not available, a non-contrast brain MRI or non-contrast head CT must be done during Screening. 5. Living at the same home or residential assisted-living facility for a minimum of 6 weeks before Screening. 6. Have an identified study partner who should have daily contact (approximately 10 hours a week or more). 7. History of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months prior to Screening. 8. CGI-S scale with a score ≥ 4 at Screening and Baseline. 9. AD subjects are required to have NPI-C: Hallucinations and Delusions (H+D) score…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.