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

RECRUITINGPhase 3Sponsored by Suven Life Sciences Limited
Actively Recruiting
PhasePhase 3
SponsorSuven Life Sciences Limited
Started2022-11-01
Est. completion2026-12
Eligibility
Age50 Years – 90 Years
Healthy vol.Accepted
Locations27 sites
View on ClinicalTrials.gov →

NCT05397639

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.

Eligibility

Age: 50 Years – 90 YearsHealthy volunteers accepted
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.

Conditions3

AgitationAlzheimer's DiseaseAlzheimer's Type Dementia

Interventions2

Masupirdine 100 mgMasupirdine 50 mg

Locations27 sites

Advanced Research Center, Inc.
Anaheim, California, 92805-5854
Clinical Research Site
ATP Clinical Research, Inc.
Costa Mesa, California, 92626-4607
Clinical Research Site
Leading Edge Research LA, LLC
Encino, California, 91316
Clinical Research Site
Neuro Pain Medical Center
Fresno, California, 93710-5473
Clinical Research Site
Neurology Center of North Orange County
Fullerton, California, 92835-1040
Clinical Research Site

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