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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

Eligibility

Eligible Ages
Between 50 Years and 90 Years
Eligible Genders
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, California 92805-5854
Contact:
Clinical Research Site

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

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

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

Neuroscience Research Center, LLC
Canton, Ohio 44718
Contact:
Clinical Research Site

Richmond Behavioral Associates
Staten Island, New York 10312-6501
Contact:
Clinical Research Site

Mid Hudson Medical Research, PLLC
New Windsor, New York 12553
Contact:
Clinical Research Site

North Suffolk Neurology
Commack, New York 11725-2808
Contact:
Clinical Research Site

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

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

Brainstorm Research
Miami, Florida 33176
Contact:
Clinical Research Site

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

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

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

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

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

Central Miami Medical Institute
Miami, Florida 33122-1335
Contact:
Clinical Research Site

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

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

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

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

Clinical Trial Network
Houston, Texas 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.