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

Agitation Alzheimer's Type Dementia

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

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called masupirdine to see if it can reduce agitation — restlessness, irritability, and combative behavior — in people living with Alzheimer's disease. **You may be eligible if...** - You have been diagnosed with Alzheimer's-type dementia - You have significant agitation symptoms confirmed by a standardized assessment - You have a caregiver who can participate in the study with you - You are living in the community (not a full-time care facility) **You may NOT be eligible if...** - You have another type of dementia (such as Lewy body dementia or frontotemporal dementia) - You have been recently hospitalized for psychiatric reasons - You are taking certain other psychiatric medications that could interfere with the study drug - You have significant heart problems or a recent stroke Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMasupirdine 50 mg

Tablet, Once Daily

DRUGMasupirdine 100 mg

Tablet, Once Daily

DRUGPlacebo

Matching Placebo Tablet, Once Daily

Locations(44)

Advanced Research Center, Inc.

Anaheim, California, United States

ATP Clinical Research, Inc.

Costa Mesa, California, United States

Leading Edge Research LA, LLC

Encino, California, United States

Neuro Pain Medical Center

Fresno, California, United States

Neurology Center of North Orange County

Fullerton, California, United States

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

Los Angeles, California, United States

Ki Health Partners, LLC

Stamford, Connecticut, United States

Allied Biomedical Research Institute

Miami, Florida, United States

Central Miami Medical Institute

Miami, Florida, United States

CCM Clinical Research Group

Miami, Florida, United States

Miami Jewish Health

Miami, Florida, United States

Novel Clinical Research Center, LLC.

Miami, Florida, United States

Brainstorm Research

Miami, Florida, United States

Combined Research Orlando Phase I-IV

Orlando, Florida, United States

Quantum Laboratories Inc

Pompano Beach, Florida, United States

Re:Cognition Health

Chicago, Illinois, United States

Insight Hospital and Medical Center Chicago

Chicago, Illinois, United States

Ocean Medical Research

Toms River, New Jersey, United States

Dent Neurologic Institute

Amherst, New York, United States

Velocity Clinical Research, Syracuse

East Syracuse, New York, United States

Velocity Clinical Research, Cleveland

Beachwood, Ohio, United States

Ralph H. Johnson VA Health Care System

Charleston, South Carolina, United States

Midlands Neurology and Pain Associates

Columbia, South Carolina, United States

Gadolin Research

Beaumont, Texas, United States

Re:Cognition Health

Fort Worth, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Clinical Trial Network

Houston, Texas, United States

Clinical Hospital Center Rijeka

Rijeka, Croatia

Polyclinic Neuron

Zagreb, Croatia

University Hospital Center Zagreb

Zagreb, Croatia

Klinika za psihijatriju Vrapce

Zagreb, Croatia

Medycyna Milorzab sp. z o.o.

Lodz, Lódzkie, Poland

FutureMeds Warszawa Centrum

Warsaw, Masovian Voivodeship, Poland

MTZ Clinical Research powered by Pratia

Warsaw, Masovian Voivodeship, Poland

Centrum Leczenia Zaburzen Pamieci Affidea

Warsaw, Masovian Voivodeship, Poland

Centrum Medyczne Silmedic Sp z o o

Katowice, Silesian Voivodeship, Poland

EMC Silesia Sp. z o.o.

Katowice, Silesian Voivodeship, Poland

Neuro-Medic Janusz Zbrojkiewicz

Katowice, Silesian Voivodeship, Poland

ClinHouse Centrum Medyczne

Zabrze, Poland

Clinical Hospital Center Dragisa Misovic Dedinje

Belgrade, Serbia

Special Hospital for Psychiatric Diseases

Kovin, Serbia

University Clinical Center Kragujevac, Clinic for Psychiatry

Kragujevac, Serbia

University Clinical Center Nis, Clinic for neurology

Niš, Serbia

Clinical Centre of Vojvodina, Clinic of Neurology

Novi Sad, Serbia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05397639

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