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

Description

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.

Conditions

Agitation, Alzheimer's Type Dementia

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Agitation
Intervention / Treatment

-

Contacts and Locations

Anaheim

Advanced Research Center, Inc., Anaheim, California, United States, 92805-5854

Costa Mesa

ATP Clinical Research, Inc., Costa Mesa, California, United States, 92626-4607

Encino

Leading Edge Research LA, LLC, Encino, California, United States, 91316

Fresno

Neuro Pain Medical Center, Fresno, California, United States, 93710-5473

Fullerton

Neurology Center of North Orange County, Fullerton, California, United States, 92835-1040

Los Angeles

Mary S Easton Center for Alzheimer's Research and Care UCLA, Los Angeles, California, United States, 90095

Stamford

Ki Health Partners, LLC, Stamford, Connecticut, United States, 06905

Maitland

ClinCloud, LLC, Maitland, Florida, United States, 32751

Miami

Allied Biomedical Research Institute, Miami, Florida, United States, 33125-2607

Miami

Central Miami Medical Institute, Miami, Florida, United States, 33125

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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.

Ages Eligible for Study

50 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Suven Life Sciences Limited,

Study Record Dates

2025-01