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

Part of paid clinical trials in Anaheim, California.

Sponsor
Suven Life Sciences Limited
Study ID
NCT05397639
Phase
PHASE3
Status
Recruiting
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Conditions

  • Agitation
  • Alzheimer's Type Dementia

Eligibility Criteria

Sex
ALL
Age
50 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Masupirdine 50 mg — DRUG
    Tablet, Once Daily
  • Masupirdine 100 mg — DRUG
    Tablet, Once Daily
  • Placebo — DRUG
    Matching Placebo Tablet, Once Daily

Study Details

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.

Key Dates

Start date
Nov 1, 2022
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
375 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low Dose Masupirdine Arm
    Tablet
  • Experimental: High Dose Masupirdine Arm
    Tablet
  • Placebo Comparator: Placebo
    Tablet

Primary Outcome Measure

Cohen-Mansfield Agitation Inventory (CMAI) [ Time Frame: From Baseline to Week 12 visit ]

Central Contacts

Locations (27)

FacilityCityStateZIPSite coordinators
Advanced Research Center, Inc.AnaheimCalifornia92805-5854
Clinical Research Site
ATP Clinical Research, Inc.Costa MesaCalifornia92626-4607
Clinical Research Site
Leading Edge Research LA, LLCEncinoCalifornia91316
Clinical Research Site
Neuro Pain Medical CenterFresnoCalifornia93710-5473
Clinical Research Site
Neurology Center of North Orange CountyFullertonCalifornia92835-1040
Clinical Research Site
Mary S Easton Center for Alzheimer's Research and Care UCLALos AngelesCalifornia90095
Clinical Research Site
Ki Health Partners, LLCStamfordConnecticut06905
Clinical Research Site
Allied Biomedical Research InstituteMiamiFlorida33125-2607
Clinical Research Site
Brainstorm ResearchMiamiFlorida33176
Clinical Research Site
CCM Clinical Research GroupMiamiFlorida33133
Clinical Research Site
Central Miami Medical InstituteMiamiFlorida33125
Clinical Research Site
Miami Jewish HealthMiamiFlorida33137
Clinical Research Site
Novel Clinical Research Center, LLC.MiamiFlorida33143
Clinical Research Site
Combined Research Orlando Phase I-IVOrlandoFlorida32807
Clinical Research Site
Quantum Laboratories IncPompano BeachFlorida33064
Clinical Research Site
Insight Hospital and Medical Center ChicagoChicagoIllinois60616
Clinical Research Site
Re:Cognition HealthChicagoIllinois60611
Clinical Research Site
Ocean Medical ResearchToms RiverNew Jersey08755
Clinical Research Site
Dent Neurologic InstituteAmherstNew York14226
Clinical Research Site
Velocity Clinical Research, SyracuseEast SyracuseNew York13057
Clinical Research Site
Velocity Clinical Research, ClevelandBeachwoodOhio44122
Clinical Research Site
Ralph H. Johnson VA Health Care SystemCharlestonSouth Carolina29401-1113
Clinical Research Site
Midlands Neurology and Pain AssociatesColumbiaSouth Carolina29205
Clinical Research Site
Gadolin ResearchBeaumontTexas77702
Clinical Research Site
Re:Cognition HealthFort WorthTexas76104
Clinical Research Site
Baylor College of MedicineHoustonTexas77030-4202
Clinical Research Site
Clinical Trial NetworkHoustonTexas77074
Clinical Research Site

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