Actively Recruiting
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Masupirdine for Treating Agitation in Alzheimer's-Type Dementia
Led by Suven Life Sciences Limited · Updated on 2026-01-12
375
Participants Needed
44
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating masupirdine, an oral tablet taken once daily, for its potential to treat agitation in people with dementia of the Alzheimer's type. This phase 3, multicenter study is randomized, double-blind, and placebo-controlled, aiming to assess the drug's efficacy, safety, tolerability, and pharmacokinetics. About 375 participants aged 50 to 90 years will be enrolled worldwide. Participants will be randomly assigned to one of three groups: low dose masupirdine (50 mg), high dose masupirdine (100 mg), or a matching placebo. Treatment will last 12 weeks, with dosing from Day 1 through Day 85. Screening will take place within approximately 4 weeks before randomization to confirm eligibility based on cognitive and agitation criteria. During the study, participants will be monitored using assessments like the Cohen-Mansfield Agitation Inventory to measure agitation changes from baseline to Week 12. Additional evaluations include the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change. Researchers will track safety and tolerability throughout. The total involvement spans the screening and 12-week treatment period, with ongoing monitoring for effects and side effects.
CONDITIONS
Brief Title
Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of dementia of the Alzheimer's type according to National Institute on Aging-Alzheimer's Association criteria
- Confirmed agitation using IPA Consensus Provisional Definition of Agitation in Cognitive Disorders
- Mini-Mental State Examination (MMSE) score between 8 and 24 inclusive
- Age between 50 and 90 years
You will not qualify if you...
- Dementia primarily due to non-Alzheimer's causes such as vascular dementia, Parkinson's disease, Lewy body disease, or frontotemporal dementia
- Agitation symptoms caused by other factors like pain, psychiatric disorders, delirium from metabolic or systemic infections, or substance use
- Participant or caregiver deemed ineligible by investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants take study medication (Masupirdine or placebo) orally once daily for agitation associated with Alzheimer's-type dementia.
Daily medication intake with periodic visits as scheduled by the study
Trial Site Locations
Total: 44 locations
1
Advanced Research Center, Inc.
Anaheim, California, United States, 92805-5854
Actively Recruiting
2
ATP Clinical Research, Inc.
Costa Mesa, California, United States, 92626-4607
Actively Recruiting
3
Leading Edge Research LA, LLC
Encino, California, United States, 91316
Actively Recruiting
4
Neuro Pain Medical Center
Fresno, California, United States, 93710-5473
Actively Recruiting
5
Neurology Center of North Orange County
Fullerton, California, United States, 92835-1040
Actively Recruiting
6
Mary S Easton Center for Alzheimer's Research and Care UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
7
Ki Health Partners, LLC
Stamford, Connecticut, United States, 06905
Actively Recruiting
8
Allied Biomedical Research Institute
Miami, Florida, United States, 33125-2607
Actively Recruiting
9
Central Miami Medical Institute
Miami, Florida, United States, 33125
Actively Recruiting
10
CCM Clinical Research Group
Miami, Florida, United States, 33133
Actively Recruiting
11
Miami Jewish Health
Miami, Florida, United States, 33137
Actively Recruiting
12
Novel Clinical Research Center, LLC.
Miami, Florida, United States, 33143
Actively Recruiting
13
Brainstorm Research
Miami, Florida, United States, 33176
Actively Recruiting
14
Combined Research Orlando Phase I-IV
Orlando, Florida, United States, 32807
Actively Recruiting
15
Quantum Laboratories Inc
Pompano Beach, Florida, United States, 33064
Actively Recruiting
16
Re:Cognition Health
Chicago, Illinois, United States, 60611
Actively Recruiting
17
Insight Hospital and Medical Center Chicago
Chicago, Illinois, United States, 60616
Actively Recruiting
18
Ocean Medical Research
Toms River, New Jersey, United States, 08755
Actively Recruiting
19
Dent Neurologic Institute
Amherst, New York, United States, 14226
Actively Recruiting
20
Velocity Clinical Research, Syracuse
East Syracuse, New York, United States, 13057
Actively Recruiting
21
Velocity Clinical Research, Cleveland
Beachwood, Ohio, United States, 44122
Actively Recruiting
22
Ralph H. Johnson VA Health Care System
Charleston, South Carolina, United States, 29401-1113
Actively Recruiting
23
Midlands Neurology and Pain Associates
Columbia, South Carolina, United States, 29205
Actively Recruiting
24
Gadolin Research
Beaumont, Texas, United States, 77702
Actively Recruiting
25
Re:Cognition Health
Fort Worth, Texas, United States, 76104
Actively Recruiting
26
Baylor College of Medicine
Houston, Texas, United States, 77030-4202
Actively Recruiting
27
Clinical Trial Network
Houston, Texas, United States, 77074
Actively Recruiting
28
Clinical Hospital Center Rijeka
Rijeka, Croatia, 51000
Actively Recruiting
29
Polyclinic Neuron
Zagreb, Croatia, 10000
Actively Recruiting
30
University Hospital Center Zagreb
Zagreb, Croatia, 10000
Actively Recruiting
31
Klinika za psihijatriju Vrapce
Zagreb, Croatia, 10090
Actively Recruiting
32
Medycyna Milorzab sp. z o.o.
Lodz, Lódzkie, Poland, 90-227
Actively Recruiting
33
FutureMeds Warszawa Centrum
Warsaw, Masovian Voivodeship, Poland, 00-215
Actively Recruiting
34
MTZ Clinical Research powered by Pratia
Warsaw, Masovian Voivodeship, Poland, 02-172
Actively Recruiting
35
Centrum Leczenia Zaburzen Pamieci Affidea
Warsaw, Masovian Voivodeship, Poland, 04-148
Actively Recruiting
36
Centrum Medyczne Silmedic Sp z o o
Katowice, Silesian Voivodeship, Poland, 40-282
Actively Recruiting
37
EMC Silesia Sp. z o.o.
Katowice, Silesian Voivodeship, Poland, 40-353
Actively Recruiting
38
Neuro-Medic Janusz Zbrojkiewicz
Katowice, Silesian Voivodeship, Poland, 40-686
Actively Recruiting
39
ClinHouse Centrum Medyczne
Zabrze, Poland, 41-807
Actively Recruiting
40
Clinical Hospital Center Dragisa Misovic Dedinje
Belgrade, Serbia, 11000
Actively Recruiting
41
Special Hospital for Psychiatric Diseases
Kovin, Serbia, 26220
Actively Recruiting
42
University Clinical Center Kragujevac, Clinic for Psychiatry
Kragujevac, Serbia, 34000
Actively Recruiting
43
University Clinical Center Nis, Clinic for neurology
Niš, Serbia, 18000
Actively Recruiting
44
Clinical Centre of Vojvodina, Clinic of Neurology
Novi Sad, Serbia, 21000
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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