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

NCT05397639 · tracked via the Priya Life Science USA tracker

Sponsor

Suven Life Sciences Limited

Phase

Phase 3

Started

2022-11-01

Last updated

2026-09-15

Condition(s) studied

AgitationAlzheimer's Type Dementia

Investigational drug(s) / intervention(s)

Masupirdine 50 mgMasupirdine 100 mgPlacebo

Masupirdine 50 mg: Tablet, Once Daily

Masupirdine 100 mg: Tablet, Once Daily

Placebo: Matching Placebo Tablet, Once Daily

Study 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

Sex

ALL

Min age

50 Years

Max age

90 Years

Healthy volunteers

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.

Primary outcome measure(s)

Cohen-Mansfield Agitation Inventory (CMAI) — From Baseline to Week 12 visit
Change in CMAI items score aligning to the International Psychogeriatric Association (IPA) agitation criteria domains (physical aggression, excessive motor activity, and verbal aggression). CMAI is a validated 29-item questionnaire to assess agitation. Each item is rated on a 7-point scale ranging from 1 "Never" to 7 "Several times per hour". Higher scores indicate worsening agitation.

Trial sites (44)

Facility	City	Region
Advanced Research Center, Inc.	Anaheim	California
ATP Clinical Research, Inc.	Costa Mesa	California
Leading Edge Research LA, LLC	Encino	California
Neuro Pain Medical Center	Fresno	California
Neurology Center of North Orange County	Fullerton	California
Mary S Easton Center for Alzheimer's Research and Care UCLA	Los Angeles	California
Ki Health Partners, LLC	Stamford	Connecticut
Allied Biomedical Research Institute	Miami	Florida
Central Miami Medical Institute	Miami	Florida
CCM Clinical Research Group	Miami	Florida
Miami Jewish Health	Miami	Florida
Novel Clinical Research Center, LLC.	Miami	Florida
Brainstorm Research	Miami	Florida
Combined Research Orlando Phase I-IV	Orlando	Florida
Quantum Laboratories Inc	Pompano Beach	Florida
Re:Cognition Health	Chicago	Illinois
Insight Hospital and Medical Center Chicago	Chicago	Illinois
Ocean Medical Research	Toms River	New Jersey
Dent Neurologic Institute	Amherst	New York
Velocity Clinical Research, Syracuse	East Syracuse	New York
Velocity Clinical Research, Cleveland	Beachwood	Ohio
Ralph H. Johnson VA Health Care System	Charleston	South Carolina
Midlands Neurology and Pain Associates	Columbia	South Carolina
Gadolin Research	Beaumont	Texas
Re:Cognition Health	Fort Worth	Texas
Baylor College of Medicine	Houston	Texas
Clinical Trial Network	Houston	Texas
Clinical Hospital Center Rijeka	Rijeka	Croatia
Polyclinic Neuron	Zagreb	Croatia
University Hospital Center Zagreb	Zagreb	Croatia
Klinika za psihijatriju Vrapce	Zagreb	Croatia
Medycyna Milorzab sp. z o.o.	Lodz	Lódzkie
FutureMeds Warszawa Centrum	Warsaw	Masovian Voivodeship
MTZ Clinical Research powered by Pratia	Warsaw	Masovian Voivodeship
Centrum Leczenia Zaburzen Pamieci Affidea	Warsaw	Masovian Voivodeship
Centrum Medyczne Silmedic Sp z o o	Katowice	Silesian Voivodeship
EMC Silesia Sp. z o.o.	Katowice	Silesian Voivodeship
Neuro-Medic Janusz Zbrojkiewicz	Katowice	Silesian Voivodeship
ClinHouse Centrum Medyczne	Zabrze	Poland
Clinical Hospital Center Dragisa Misovic Dedinje	Belgrade	Serbia

+ 4 more sites — see the full list on the official registry below.

More Suven Life Sciences Limited trials in the USA

A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE) Recruiting

Other trials for the same condition

Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type Recruiting

Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease Recruiting

A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05397639 on ClinicalTrials.gov ↗ ← All trials in the USA