Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type

Purpose

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.

Conditions

  • Agitation
  • Alzheimer's Type Dementia

Eligibility

Eligible Ages
Between 50 Years and 90 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double-Blind

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Low Dose Masupirdine Arm 		Tablet
  • Drug: Masupirdine 50 mg
    Tablet, Once Daily
    Other names:
    • SUVN-502
Experimental
High Dose Masupirdine Arm 		Tablet
  • Drug: Masupirdine 100 mg
    Tablet, Once Daily
    Other names:
    • SUVN-502
Placebo Comparator
Placebo 		Tablet
  • Drug: Placebo
    Matching Placebo Tablet, Once Daily

Recruiting Locations

Advanced Research Center, Inc.
Anaheim 5323810, California 5332921 92805-5854
Contact:
Clinical Research Site

ATP Clinical Research, Inc.
Costa Mesa 5339840, California 5332921 92626-4607
Contact:
Clinical Research Site

Leading Edge Research LA, LLC
Encino 5346649, California 5332921 91316
Contact:
Clinical Research Site

Neuro Pain Medical Center
Fresno 5350937, California 5332921 93710-5473
Contact:
Clinical Research Site

Neurology Center of North Orange County
Fullerton 5351247, California 5332921 92835-1040
Contact:
Clinical Research Site

Mary S Easton Center for Alzheimer's Research and Care UCLA
Los Angeles 5368361, California 5332921 90095
Contact:
Clinical Research Site

Ki Health Partners, LLC
Stamford 4843564, Connecticut 4831725 06905
Contact:
Clinical Research Site

ClinCloud, LLC
Maitland 4163220, Florida 4155751 32751
Contact:
Clinical Research Site

Allied Biomedical Research Institute
Miami 4164138, Florida 4155751 33125-2607
Contact:
Clinical Research Site

Central Miami Medical Institute
Miami 4164138, Florida 4155751 33125
Contact:
Clinical Research Site

CCM Clinical Research Group
Miami 4164138, Florida 4155751 33133
Contact:
Clinical Research Site

Miami Jewish Health
Miami 4164138, Florida 4155751 33137
Contact:
Clinical Research Site

Novel Clinical Research Center, LLC.
Miami 4164138, Florida 4155751 33143
Contact:
Clinical Research Site

Brainstorm Research
Miami 4164138, Florida 4155751 33176
Contact:
Clinical Research Site

Combined Research Orlando Phase I-IV
Orlando 4167147, Florida 4155751 32807
Contact:
Clinical Research Site

Quantum Laboratories Inc
Pompano Beach 4169014, Florida 4155751 33064
Contact:
Clinical Research Site

Re:Cognition Health
Chicago 4887398, Illinois 4896861 60611
Contact:
Clinical Research Site

Insight Hospital and Medical Center Chicago
Chicago 4887398, Illinois 4896861 60616
Contact:
Clinical Research Site

Ocean Medical Research
Toms River 4504476, New Jersey 5101760 08755
Contact:
Clinical Research Site

Dent Neurologic Institute
Amherst 5107129, New York 5128638 14226
Contact:
Clinical Research Site

Velocity Clinical Research, Syracuse
East Syracuse 5116079, New York 5128638 13057
Contact:
Clinical Research Site

Regional Neurological Associates
The Bronx 5110266, New York 5128638 10466
Contact:
Clinical Research Site

Velocity Clinical Research, Cleveland
Beachwood 5146711, Ohio 5165418 44122
Contact:
Clinical Research Site

Ralph H. Johnson VA Health Care System
Charleston 4574324, South Carolina 4597040 29401-1113
Contact:
Clinical Research Site

Midlands Neurology and Pain Associates
Columbia 4575352, South Carolina 4597040 29205
Contact:
Clinical Research Site

Gadolin Research
Beaumont 4672989, Texas 4736286 77702
Contact:
Clinical Research Site

Re:Cognition Health
Fort Worth 4691930, Texas 4736286 76104
Contact:
Clinical Research Site

Baylor College of Medicine
Houston 4699066, Texas 4736286 77030-4202
Contact:
Clinical Research Site

Clinical Trial Network
Houston 4699066, Texas 4736286 77074
Contact:
Clinical Research Site

More Details

NCT ID
NCT05397639
Status
Recruiting
Sponsor
Suven Life Sciences Limited

Study Contact

Study Contact
+9140 2319 3956
agitation@suven.com

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.

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center