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Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type
NCT05397639 · Suven Life Sciences Limited
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
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
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.
Study design
Enrollment target: 375 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2022-11-01
Estimated completion: 2026-12
Last updated: 2026-09-15
Interventions
Drug: Masupirdine 50 mgDrug: Masupirdine 100 mgDrug: Placebo
Primary outcomes
- • Cohen-Mansfield Agitation Inventory (CMAI) (From Baseline to Week 12 visit)
Sponsor
Suven Life Sciences Limited · industry
All 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