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

Phase 3

Recruiting

• Conditions: Agitation; Alzheimer's Type Dementia
• Interventions: Drug: Masupirdine 50 mg; Drug: Placebo; Drug: Masupirdine 100 mg

• Registration Number: NCT05397639
• Lead Sponsor: Suven Life Sciences Limited

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.

Study Timeline

• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-05-25
• Study First Posted: 2022-05-31
• Study Start: 2022-11-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-20
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 375

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose Masupirdine Arm	Masupirdine 50 mg	Tablet
Placebo	Placebo	Tablet
High Dose Masupirdine Arm	Masupirdine 100 mg	Tablet

Primary Outcome Measures

Name	Time	Method
Cohen-Mansfield Agitation Inventory (CMAI)	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 Outcome Measures

Name	Time	Method
Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGI-C)	From Baseline to Week 12 visit	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.

Trial Locations

Locations (51)

Advanced Research Center, Inc.; 🇺🇸 Anaheim, California, United States

ATP Clinical Research, Inc.; 🇺🇸 Costa Mesa, California, United States

Leading Edge Research LA, LLC; 🇺🇸 Encino, California, United States

Neuro Pain Medical Center; 🇺🇸 Fresno, California, United States

Neurology Center of North Orange County; 🇺🇸 Fullerton, California, United States

Mary S Easton Center for Alzheimer's Research and Care UCLA; 🇺🇸 Los Angeles, California, United States

Ki Health Partners, LLC; 🇺🇸 Stamford, Connecticut, United States

ClinCloud, LLC; 🇺🇸 Maitland, Florida, United States

Allied Biomedical Research Institute; 🇺🇸 Miami, Florida, United States

Central Miami Medical Institute; 🇺🇸 Miami, Florida, United States

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