A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Masupirdine (SUVN-502) for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type
Overview
- Phase
- Phase 3
- Intervention
- Masupirdine 50 mg
- Conditions
- Agitation
- Sponsor
- Suven Life Sciences Limited
- Enrollment
- 375
- Locations
- 60
- Primary Endpoint
- Cohen-Mansfield Agitation Inventory (CMAI)
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Has a diagnosis of dementia of the Alzheimer's type according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria.
- •Has confirmed agitation using the IPA Consensus Provisional Definition of Agitation in Cognitive Disorders.
- •Has a score between 8 and 24 (both inclusive) on Mini-Mental State Examination (MMSE).
Exclusion Criteria
- •Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, parkinson's disease, lewy body disease, frontotemporal dementia)
- •Has symptoms of agitation that are not secondary to Alzheimer's disease (eg, pain, other psychiatric disorder, or delirium due to a metabolic disorder, systemic infection, or substance-induced).
- •Participant (or caregiver) is deemed otherwise ineligible for participation in this study in the investigator's judgement.
Arms & Interventions
Low Dose Masupirdine Arm
Tablet
Intervention: Masupirdine 50 mg
High Dose Masupirdine Arm
Tablet
Intervention: Masupirdine 100 mg
Placebo
Tablet
Intervention: Placebo
Outcomes
Primary Outcomes
Cohen-Mansfield Agitation Inventory (CMAI)
Time Frame: From Baseline to Week 12 visit
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.
Secondary Outcomes
- Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGI-C)(From Baseline to Week 12 visit)