RecruitingPhase 3NCT05397639
Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type
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
Sponsor
Suven Life Sciences Limited
Enrollment
375 participants
Start Date
Nov 1, 2022
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 50 YearsMax Age: 90 Years
Inclusion Criteria3
- 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 Criteria3
- 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.
Interventions
DRUGMasupirdine 50 mg
Tablet, Once Daily
DRUGMasupirdine 100 mg
Tablet, Once Daily
DRUGPlacebo
Matching Placebo Tablet, Once Daily
Locations(44)
View Full Details on ClinicalTrials.gov
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NCT05397639
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