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

Agitation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05397639
• Other study ID #: CTP3S1502HT6
• Secondary ID: 2021-003405-22
• Status: Recruiting
• Phase: Phase 3
• Start date: November 1, 2022
• Est. completion date: January 2025

Study information

• Verified date: January 2024
• Source: Suven Life Sciences Limited
• Contact: Study Contact
• Phone: +9140 2319 3956
• Email: agitation[@]suven.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 375
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Agitation
• Alzheimer Disease
• Alzheimer's Type Dementia
• Dementia
• Psychomotor Agitation

Intervention

Drug:
• Masupirdine 50 mg
Tablet, Once Daily
• Masupirdine 100 mg
Tablet, Once Daily
• Placebo
Matching Placebo Tablet, Once Daily

Locations

Country	Name	City	State
Croatia	Clinical Hospital Center Rijeka	Rijeka
Croatia	Klinika za psihijatriju Sveti Ivan	Zagreb
Croatia	Klinika za psihijatriju Vrapce	Zagreb
Croatia	Polyclinic Neuron	Zagreb
Croatia	University Hospital Center Zagreb	Zagreb
Poland	Centrum Medyczne Silmedic Sp z o o	Katowice	Slaskie
Poland	Neuro-Medic Janusz Zbrojkiewicz	Katowice	Slaskie
Poland	Novo-Med Zielinski i wsp. Sp.J.	Katowice	Slaskie
Poland	Krakowska Akademia Neurologii Sp. z o.o.	Kraków	Malopolskie
Poland	Medycyna Milorzab sp. z o.o.	Lódz	Lódzkie
Poland	Osrodek Badan Klinicznych Appletreeclinics	Lódz	Lódzkie
Poland	Clinical Best Solutions - Lublin	Lublin	Lubelskie
Poland	FutureMeds Warszawa Centrum	Warszawa	Mazowieckie
Poland	EMC Instytut Medyczny S.A.	Wroclaw	Dolnoslaskie
Serbia	Clinical Hospital Center Dragisa Misovic Dedinje	Belgrade
Serbia	Military Medical Academy, Clinic of Neurology	Belgrade
Serbia	University Clinical Center of Serbia, Clinic for neurology	Belgrade
Serbia	Special Hospital for Psychiatric Diseases	Kovin
Serbia	University Clinical Center Kragujevac, Clinic for Psychiatry	Kragujevac
Serbia	University Clinical Center Nis, Clinic for neurology	Niš
Serbia	Clinical Centre of Vojvodina, Clinic of Neurology	Novi Sad
Serbia	Special Hospital for Psychiatric Diseases ''Dr Slavoljub Bakalovic''	Vršac
United States	Dent Neurologic Institute	Amherst	New York
United States	Advanced Research Center, Inc.	Anaheim	California
United States	Neuroscience Research Center, LLC	Canton	Ohio
United States	Ralph H. Johnson VA Health Care System	Charleston	South Carolina
United States	North Suffolk Neurology	Commack	New York
United States	ATP Clinical Research, Inc.	Costa Mesa	California
United States	Neuro Pain Medical Center	Fresno	California
United States	Neurology Center of North Orange County	Fullerton	California
United States	Baylor College of Medicine	Houston	Texas
United States	Clinical Trial Network	Houston	Texas
United States	Mary S Easton Center for Alzheimer's Research and Care UCLA	Los Angeles	California
United States	Allied Biomedical Research Institute	Miami	Florida
United States	Brainstorm Research	Miami	Florida
United States	CCM Clinical Research Group	Miami	Florida
United States	Central Miami Medical Institute	Miami	Florida
United States	Miami Jewish Health	Miami	Florida
United States	Novel Clinical Research Center, LLC.	Miami	Florida
United States	Mid Hudson Medical Research, PLLC	New Windsor	New York
United States	Combined Research Orlando Phase I-IV	Orlando	Florida
United States	Quantum Laboratories Inc	Pompano Beach	Florida
United States	Ki Health Partners, LLC	Stamford	Connecticut
United States	Richmond Behavioral Associates	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Suven Life Sciences Limited

Countries where clinical trial is conducted

United States,  Croatia,  Poland,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGI-C)	Change in mADCS-CGI-C. The mADCS-CGI-C is a modification of the ADCS-CGI-C instrument that focuses specifically on agitation. It is a 7-point Likert scale that ranges from marked improvement scored as 1 to marked worsening scored as 7. The range is from 1 to 7. Higher scores indicate worsening agitation.	From Baseline to Week 12 visit