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

NCT05397639 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CTP3S1502HT62021-003405-22
• Study Type: interventional
• Target: 375
• Locations: 4 countries
• Sites: 44

Brief 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.

Conditions

Agitation; Alzheimer's Type Dementia

Keywords

Masupirdine; SUVN-502; Phase 3; Agitation

Outcome Measures

Primary Outcomes (1)

• Cohen-Mansfield Agitation Inventory (CMAI)

  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.

  From Baseline to Week 12 visit

Secondary Outcomes (1)

• Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGI-C)

  From Baseline to Week 12 visit

Study Arms (3)

Low Dose Masupirdine Arm

EXPERIMENTAL

Tablet

Drug: Masupirdine 50 mg

High Dose Masupirdine Arm

EXPERIMENTAL

Tablet

Drug: Masupirdine 100 mg

Placebo

PLACEBO COMPARATOR

Tablet

Drug: Placebo

Interventions

Masupirdine 50 mg DRUG

Tablet, Once Daily

Also known as: SUVN-502

Low Dose Masupirdine Arm

Masupirdine 100 mg DRUG

Tablet, Once Daily

Also known as: SUVN-502

High Dose Masupirdine Arm

Placebo DRUG

Matching Placebo Tablet, Once Daily

Placebo

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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.

Sponsors & Collaborators

• Suven Life Sciences Limited: lead

Study Sites (44)

Advanced Research Center, Inc.

Anaheim, California, 92805-5854, United States

RECRUITING

ATP Clinical Research, Inc.

Costa Mesa, California, 92626-4607, United States

RECRUITING

Leading Edge Research LA, LLC

Encino, California, 91316, United States

RECRUITING

Neuro Pain Medical Center

Fresno, California, 93710-5473, United States

RECRUITING

Neurology Center of North Orange County

Fullerton, California, 92835-1040, United States

RECRUITING

Mary S Easton Center for Alzheimer's Research and Care UCLA

Los Angeles, California, 90095, United States

RECRUITING

Ki Health Partners, LLC

Stamford, Connecticut, 06905, United States

RECRUITING

Allied Biomedical Research Institute

Miami, Florida, 33125-2607, United States

RECRUITING

Central Miami Medical Institute

Miami, Florida, 33125, United States

RECRUITING

CCM Clinical Research Group

Miami, Florida, 33133, United States

RECRUITING

Miami Jewish Health

Miami, Florida, 33137, United States

RECRUITING

Novel Clinical Research Center, LLC.

Miami, Florida, 33143, United States

RECRUITING

Brainstorm Research

Miami, Florida, 33176, United States

RECRUITING

Combined Research Orlando Phase I-IV

Orlando, Florida, 32807, United States

RECRUITING

Quantum Laboratories Inc

Pompano Beach, Florida, 33064, United States

RECRUITING

Re:Cognition Health

Chicago, Illinois, 60611, United States

RECRUITING

Insight Hospital and Medical Center Chicago

Chicago, Illinois, 60616, United States

RECRUITING

Ocean Medical Research

Toms River, New Jersey, 08755, United States

RECRUITING

Dent Neurologic Institute

Amherst, New York, 14226, United States

RECRUITING

Velocity Clinical Research, Syracuse

East Syracuse, New York, 13057, United States

RECRUITING

Velocity Clinical Research, Cleveland

Beachwood, Ohio, 44122, United States

RECRUITING

Ralph H. Johnson VA Health Care System

Charleston, South Carolina, 29401-1113, United States

RECRUITING

Midlands Neurology and Pain Associates

Columbia, South Carolina, 29205, United States

RECRUITING

Gadolin Research

Beaumont, Texas, 77702, United States

RECRUITING

Re:Cognition Health

Fort Worth, Texas, 76104, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030-4202, United States

RECRUITING

Clinical Trial Network

Houston, Texas, 77074, United States

RECRUITING

Clinical Hospital Center Rijeka

Rijeka, 51000, Croatia

RECRUITING

Polyclinic Neuron

Zagreb, 10000, Croatia

RECRUITING

University Hospital Center Zagreb

Zagreb, 10000, Croatia

RECRUITING

Klinika za psihijatriju Vrapce

Zagreb, 10090, Croatia

RECRUITING

Medycyna Milorzab sp. z o.o.

Lodz, Lódzkie, 90-227, Poland

RECRUITING

FutureMeds Warszawa Centrum

Warsaw, Masovian Voivodeship, 00-215, Poland

RECRUITING

MTZ Clinical Research powered by Pratia

Warsaw, Masovian Voivodeship, 02-172, Poland

RECRUITING

Centrum Leczenia Zaburzen Pamieci Affidea

Warsaw, Masovian Voivodeship, 04-148, Poland

RECRUITING

Centrum Medyczne Silmedic Sp z o o

Katowice, Silesian Voivodeship, 40-282, Poland

RECRUITING

EMC Silesia Sp. z o.o.

Katowice, Silesian Voivodeship, 40-353, Poland

RECRUITING

Neuro-Medic Janusz Zbrojkiewicz

Katowice, Silesian Voivodeship, 40-686, Poland

RECRUITING

ClinHouse Centrum Medyczne

Zabrze, 41-807, Poland

RECRUITING

Clinical Hospital Center Dragisa Misovic Dedinje

Belgrade, 11000, Serbia

RECRUITING

Special Hospital for Psychiatric Diseases

Kovin, 26220, Serbia

RECRUITING

University Clinical Center Kragujevac, Clinic for Psychiatry

Kragujevac, 34000, Serbia

RECRUITING

University Clinical Center Nis, Clinic for neurology

Niš, 18000, Serbia

RECRUITING

Clinical Centre of Vojvodina, Clinic of Neurology

Novi Sad, 21000, Serbia

RECRUITING

Related Links

• The study drug, Masupirdine (SUVN-502), is being investigated for the treatment of agitation associated with dementia of the Alzheimer's type.

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

1-((2-bromophenyl)sulfonyl)-5-methoxy-3-((4-methyl-1-piperazinyl)methyl)-1H-indole dimesylate monohydrate

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Central Study Contacts

Study Contact

CONTACT

+9140 2319 3956; agitation@suven.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: May 31, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (5); CR (4); PL (8); US (27)