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

Suven Life Sciences

Status and phase: Enrolling; Phase 3

Conditions: Agitation; Alzheimer's Type Dementia

Treatments: Drug: Masupirdine 100 mg; Drug: Masupirdine 50 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05397639

2021-003405-22 (EudraCT Number)

CTP3S1502HT6

Details and patient eligibility

About

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.

Full 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.

Enrollment: 375 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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375 participants in 3 patient groups, including a placebo group

Low Dose Masupirdine Arm

Experimental group

Description:

Tablet

Treatment:

Drug: Masupirdine 50 mg

High Dose Masupirdine Arm

Experimental group

Description:

Tablet

Treatment:

Drug: Masupirdine 100 mg

Placebo

Placebo Comparator group

Description:

Tablet

Treatment:

Drug: Placebo