A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease
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.
Key Inclusion Criteria:
Is a male or female aged 55 to 90 years, inclusive, at Screening.
Can understand the nature of the trial and protocol requirements and provide informed consent or assent before any study assessments are performed.
Meets clinical criteria for Possible AD or Probable AD.
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.
Living at the same home or residential assisted-living facility for a minimum of 6 weeks before Screening.
Have an identified study partner who should have daily contact (approximately 10 hours a week or more).
History of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months prior to Screening.
CGI-S scale with a score ≥ 4 at Screening and Baseline.
AD subjects are required to have NPI-C: Hallucinations and Delusions (H+D) score of ≥ 6 AND meet at least 1 of the following criteria at Screening and Baseline:
MMSE score of 8 to 22, inclusive, at Screening.
Key Exclusion Criteria:
Clinical.Trials@bms.com855-907-3286
Chaidari, Athens, Attica 124 62, Greece
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