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

Sponsor

Suven Life Sciences Limited (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05397639

Collaborator

(none)

375

Enrollment

Locations

Arms

Anticipated Duration (Months)

187.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Agitation Alzheimer's Type Dementia	Drug: Masupirdine 50 mg Drug: Masupirdine 100 mg Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

375 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Double-Blind

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low Dose Masupirdine Arm Tablet	Drug: Masupirdine 50 mg Tablet, Once Daily Other Names: SUVN-502
Experimental: High Dose Masupirdine Arm Tablet	Drug: Masupirdine 100 mg Tablet, Once Daily Other Names: SUVN-502
Placebo Comparator: Placebo Tablet	Drug: Placebo Matching Placebo Tablet, Once Daily

Arm

Intervention/Treatment

Experimental: Low Dose Masupirdine Arm

Tablet

Drug: Masupirdine 50 mg

Tablet, Once Daily

Other Names:

SUVN-502

Experimental: High Dose Masupirdine Arm

Tablet

Drug: Masupirdine 100 mg

Tablet, Once Daily

Other Names:

SUVN-502

Placebo Comparator: Placebo

Tablet

Drug: Placebo

Matching Placebo Tablet, Once Daily

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.