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

a study on Agitation Alzheimer's Disease Dementia

Summary

Eligibility
for people ages 50-90 (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

Summary

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.

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

Details

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.

Keywords

Agitation, Alzheimer's Type Dementia, Masupirdine, SUVN-502, Phase 3, Dementia, Alzheimer Disease, Psychomotor Agitation, 1-((2-bromophenyl)sulfonyl)-5-methoxy-3-((4-methyl-1-piperazinyl)methyl)-1H-indole dimesylate monohydrate, Masupirdine 50 mg, Masupirdine 100 mg

Eligibility

You can join if…

Open to people ages 50-90

  • 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).

You CAN'T join if...

  • 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.

Locations

  • Mary S Easton Center for Alzheimer's Research and Care UCLA accepting new patients
    Los Angeles California 90095 United States
  • ATP Clinical Research, Inc. accepting new patients
    Costa Mesa California 92626-4607 United States
  • Neuro Pain Medical Center accepting new patients
    Fresno California 93710-5473 United States
  • Leading Edge Research LA, LLC accepting new patients
    Encino California 91316 United States
  • Advanced Research Center, Inc. accepting new patients
    Anaheim California 92805-5854 United States
  • Neurology Center of North Orange County accepting new patients
    Fullerton California 92835-1040 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Suven Life Sciences Limited
Links
The study drug, Masupirdine (SUVN-502), is being investigated for the treatment of agitation associated with dementia of the Alzheimer's type.
ID
NCT05397639
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 375 study participants
Last Updated