Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Agitation, Alzheimer's Type Dementia

Intervention / Treatment
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* Drug: Masupirdine 50 mg
* Drug: Masupirdine 100 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Dose Masupirdine Arm<br>Tablet | Drug: Masupirdine 50 mg<br>* Tablet, Once Daily<br>* Other names: SUVN-502;|
| Experimental: High Dose Masupirdine Arm<br>Tablet | Drug: Masupirdine 100 mg<br>* Tablet, Once Daily<br>* Other names: SUVN-502;|
| Placebo Comparator: Placebo<br>Tablet | Drug: Placebo<br>* Matching Placebo Tablet, Once Daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From Baseline to Week 12 visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From Baseline to Week 12 visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Masupirdine, SUVN-502, Phase 3, Agitation