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NCT05397639PHASE3Recruiting

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

Suven Life Sciences Limited

Start Date

11/1/2022

Completion Date

12/1/2026

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.

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.

Eligibility Criteria

Age Range: 50 years to 90 years

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.

Interventions

DRUG

Masupirdine 50 mg

DRUG

Masupirdine 100 mg

DRUG

Placebo

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Conditions

AgitationAlzheimer's Type Dementia

Locations

Advanced Research Center, Inc.

Anaheim, California 92805-5854

United States

ATP Clinical Research, Inc.

Costa Mesa, California 92626-4607

United States

Leading Edge Research LA, LLC

Encino, California 91316

United States

Neuro Pain Medical Center

Fresno, California 93710-5473

United States

Neurology Center of North Orange County

Fullerton, California 92835-1040

United States

Mary S Easton Center for Alzheimer's Research and Care UCLA

Los Angeles, California 90095

United States

Ki Health Partners, LLC

Stamford, Connecticut 06905

United States

Allied Biomedical Research Institute

Miami, Florida 33125-2607

United States

Central Miami Medical Institute

Miami, Florida 33125

United States

CCM Clinical Research Group

Miami, Florida 33133

United States

Miami Jewish Health

Miami, Florida 33137

United States

Novel Clinical Research Center, LLC.

Miami, Florida 33143

United States

Brainstorm Research

Miami, Florida 33176

United States

Combined Research Orlando Phase I-IV

Orlando, Florida 32807

United States

Quantum Laboratories Inc

Pompano Beach, Florida 33064

United States

Re:Cognition Health

Chicago, Illinois 60611

United States

Insight Hospital and Medical Center Chicago

Chicago, Illinois 60616

United States

Ocean Medical Research

Toms River, New Jersey 08755

United States

Dent Neurologic Institute

Amherst, New York 14226

United States

Velocity Clinical Research, Syracuse

East Syracuse, New York 13057

United States

Velocity Clinical Research, Cleveland

Beachwood, Ohio 44122

United States

Ralph H. Johnson VA Health Care System

Charleston, South Carolina 29401-1113

United States

Midlands Neurology and Pain Associates

Columbia, South Carolina 29205

United States

Gadolin Research

Beaumont, Texas 77702

United States

Re:Cognition Health

Fort Worth, Texas 76104

United States

Baylor College of Medicine

Houston, Texas 77030-4202

United States

Clinical Trial Network

Houston, Texas 77074

United States

Clinical Hospital Center Rijeka

Rijeka, 51000

Croatia

Polyclinic Neuron

Zagreb, 10000

Croatia

University Hospital Center Zagreb

Zagreb, 10000

Croatia

Klinika za psihijatriju Vrapce

Zagreb, 10090

Croatia

Medycyna Milorzab sp. z o.o.

Lodz, Lódzkie 90-227

Poland

FutureMeds Warszawa Centrum

Warsaw, Masovian Voivodeship 00-215

Poland

MTZ Clinical Research powered by Pratia

Warsaw, Masovian Voivodeship 02-172

Poland

Centrum Leczenia Zaburzen Pamieci Affidea

Warsaw, Masovian Voivodeship 04-148

Poland

Centrum Medyczne Silmedic Sp z o o

Katowice, Silesian Voivodeship 40-282

Poland

EMC Silesia Sp. z o.o.

Katowice, Silesian Voivodeship 40-353

Poland

Neuro-Medic Janusz Zbrojkiewicz

Katowice, Silesian Voivodeship 40-686

Poland

ClinHouse Centrum Medyczne

Zabrze, 41-807

Poland

Clinical Hospital Center Dragisa Misovic Dedinje

Belgrade, 11000

Serbia

Special Hospital for Psychiatric Diseases

Kovin, 26220

Serbia

University Clinical Center Kragujevac, Clinic for Psychiatry

Kragujevac, 34000

Serbia

University Clinical Center Nis, Clinic for neurology

Niš, 18000

Serbia

Clinical Centre of Vojvodina, Clinic of Neurology

Novi Sad, 21000

Serbia