Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type
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
Interventions
Masupirdine 50 mg
Masupirdine 100 mg
Placebo
Conditions
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