The trial is taking place at:
N

Neuro Pain Medical Center | Fresno, CA

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

S

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

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

Trial contacts and locations

45

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Central trial contact

Study Contact

Data sourced from clinicaltrials.gov

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