This study will be conducted to evaluate the efficacy, safety, tolerability, and pharmacokinetics of masupirdine compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.
This is a multicenter, randomized, double-blind, placebo-controlled study, consisting of 12 weeks of treatment. Approximately 375 participants will be enrolled at approximately 50 centers worldwide. Study medication will be administered orally once-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
375
Cohen-Mansfield Agitation Inventory (CMAI)
Change in CMAI items score aligning to the International Psychogeriatric Association (IPA) agitation criteria domains (physical aggression, excessive motor activity, and verbal aggression). CMAI is a validated 29-item questionnaire to assess agitation. Each item is rated on a 7-point scale ranging from 1 "Never" to 7 "Several times per hour". Higher scores indicate worsening agitation.
Time frame: From Baseline to Week 12 visit
Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGI-C)
Change in mADCS-CGI-C. The mADCS-CGI-C is a modification of the ADCS-CGI-C instrument that focuses specifically on agitation. It is a 7-point Likert scale that ranges from marked improvement scored as 1 to marked worsening scored as 7. The range is from 1 to 7. Higher scores indicate worsening agitation.
Time frame: From Baseline to Week 12 visit
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