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
Status: Recruiting
Location: See all (52) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 90
Healthy Volunteers: f
View:
• 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).
Locations
United States
California
Advanced Research Center, Inc.
RECRUITING
Anaheim
ATP Clinical Research, Inc.
RECRUITING
Costa Mesa
Leading Edge Research LA, LLC
RECRUITING
Encino
Neuro Pain Medical Center
RECRUITING
Fresno
Neurology Center of North Orange County
RECRUITING
Fullerton
Mary S Easton Center for Alzheimer's Research and Care UCLA
RECRUITING
Los Angeles
Connecticut
Ki Health Partners, LLC
RECRUITING
Stamford
Florida
ClinCloud, LLC
RECRUITING
Maitland
Allied Biomedical Research Institute
RECRUITING
Miami
Brainstorm Research
RECRUITING
Miami
CCM Clinical Research Group
RECRUITING
Miami
Central Miami Medical Institute
RECRUITING
Miami
Miami Jewish Health
RECRUITING
Miami
Novel Clinical Research Center, LLC.
RECRUITING
Miami
Combined Research Orlando Phase I-IV
RECRUITING
Orlando
Quantum Laboratories Inc
RECRUITING
Pompano Beach
Illinois
Insight Hospital and Medical Center Chicago
RECRUITING
Chicago
Re:Cognition Health
RECRUITING
Chicago
New Jersey
Ocean Medical Research
RECRUITING
Toms River
New York
Dent Neurologic Institute
RECRUITING
Amherst
Velocity Clinical Research, Syracuse
RECRUITING
East Syracuse
Regional Neurological Associates
RECRUITING
The Bronx
Ohio
Velocity Clinical Research, Cleveland
RECRUITING
Beachwood
South Carolina
Ralph H. Johnson VA Health Care System
RECRUITING
Charleston
Midlands Neurology and Pain Associates
RECRUITING
Columbia
Texas
Gadolin Research
RECRUITING
Beaumont
Re:Cognition Health
RECRUITING
Fort Worth
Baylor College of Medicine
RECRUITING
Houston
Clinical Trial Network
RECRUITING
Houston
Other Locations
Croatia
Clinical Hospital Center Rijeka
RECRUITING
Rijeka
Klinika za psihijatriju Sveti Ivan
RECRUITING
Zagreb
Klinika za psihijatriju Vrapce
RECRUITING
Zagreb
Polyclinic Neuron
RECRUITING
Zagreb
University Hospital Center Zagreb
RECRUITING
Zagreb
Poland
Centrum Medyczne Silmedic Sp z o o
RECRUITING
Katowice
EMC Silesia Sp. z o.o.
RECRUITING
Katowice
Neuro-Medic Janusz Zbrojkiewicz
RECRUITING
Katowice
Medycyna Milorzab sp. z o.o.
RECRUITING
Lodz
Osrodek Badan Klinicznych Appletreeclinics
RECRUITING
Lodz
Clinical Best Solutions - Lublin
RECRUITING
Lublin
Centrum Leczenia Zaburzen Pamieci Affidea
RECRUITING
Warsaw
FutureMeds Warszawa Centrum
RECRUITING
Warsaw
MTZ Clinical Research powered by Pratia
RECRUITING
Warsaw
EMC Instytut Medyczny S.A.
RECRUITING
Wroclaw
Serbia
Clinical Hospital Center Dragisa Misovic Dedinje
RECRUITING
Belgrade
Military Medical Academy, Clinic of Neurology
RECRUITING
Belgrade
University Clinical Center of Serbia, Clinic for neurology
RECRUITING
Belgrade
Special Hospital for Psychiatric Diseases
RECRUITING
Kovin
University Clinical Center Kragujevac, Clinic for Psychiatry
RECRUITING
Kragujevac
University Clinical Center Nis, Clinic for neurology
RECRUITING
Niš
Clinical Centre of Vojvodina, Clinic of Neurology
RECRUITING
Novi Sad
Special Hospital for Psychiatric Diseases ''Dr Slavoljub Bakalovic''
RECRUITING
Vršac
Contact Information
Primary
Study Contact
agitation@suven.com
+9140 2319 3956
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 375
Treatments
Experimental: Low Dose Masupirdine Arm
Tablet
Experimental: High Dose Masupirdine Arm
Tablet
Placebo_comparator: Placebo
Tablet
Authors
Related Therapeutic Areas
Sponsors
Leads: Suven Life Sciences Limited