CCM Clinical Research Group | Miami, FL
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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.
Enrollment
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Inclusion and exclusion criteria
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.
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:
Primary purpose
Allocation
Interventional model
Masking
400 participants in 2 patient groups, including a placebo group
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Central trial contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; First line of the email MUST contain the NCT# and Site #.
Data sourced from clinicaltrials.gov
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