Clinical trial NCT05397639: Masupirdine for the Treatment of Agitation in 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Agitation
Alzheimer's Type Dementia
Keywords: Masupirdine
SUVN-502
Phase 3
Agitation
Lead sponsor: Suven Life Sciences Limited
Sponsor class: INDUSTRY
First posted: 2022-05-31
Enrollment: 375
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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 outcomes:
measure: Cohen-Mansfield Agitation Inventory (CMAI)
timeFrame: From Baseline to Week 12 visit
Secondary outcomes:
measure: Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGI-C)
timeFrame: From Baseline to Week 12 visit
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Costa Mesa
country: United States
facility: ATP Clinical Research, Inc.
state: California
city: Encino
country: United States
facility: Leading Edge Research LA, LLC
state: California
city: Fresno
country: United States
facility: Neuro Pain Medical Center
state: California
city: Fullerton
country: United States
facility: Neurology Center of North Orange County
state: California
city: Los Angeles
country: United States
facility: Mary S Easton Center for Alzheimer's Research and Care UCLA
state: California
city: Stamford
country: United States
facility: Ki Health Partners, LLC
state: Connecticut
city: Maitland
country: United States
facility: ClinCloud, LLC
state: Florida
city: Miami
country: United States
facility: Allied Biomedical Research Institute
state: Florida
city: Miami
country: United States
facility: Central Miami Medical Institute
state: Florida
city: Miami
country: United States
facility: CCM Clinical Research Group
state: Florida
city: Miami
country: United States
facility: Miami Jewish Health
state: Florida
city: Miami
country: United States
facility: Novel Clinical Research Center, LLC.
state: Florida
city: Miami
country: United States
facility: Brainstorm Research
state: Florida
city: Orlando
country: United States
facility: Combined Research Orlando Phase I-IV
state: Florida
city: Pompano Beach
country: United States
facility: Quantum Laboratories Inc
state: Florida
city: Chicago
country: United States
facility: Re:Cognition Health
state: Illinois
city: Chicago
country: United States
facility: Insight Hospital and Medical Center Chicago
state: Illinois
city: Toms River
country: United States
facility: Ocean Medical Research
state: New Jersey
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
city: Bronx
country: United States
facility: Regional Neurological Associates
state: New York
city: East Syracuse
country: United States
facility: Velocity Clinical Research, Syracuse
state: New York
city: Beachwood
country: United States
facility: Velocity Clinical Research, Cleveland
state: Ohio
city: Charleston
country: United States
facility: Ralph H. Johnson VA Health Care System
state: South Carolina
city: Columbia
country: United States
facility: Midlands Neurology and Pain Associates
state: South Carolina
city: Beaumont
country: United States
facility: Gadolin Research
state: Texas
city: Fort Worth
country: United States
facility: Re:Cognition Health
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Rijeka
country: Croatia
facility: Clinical Hospital Center Rijeka
city: Zagreb
country: Croatia
facility: Polyclinic Neuron
city: Zagreb
country: Croatia
facility: University Hospital Center Zagreb
city: Zagreb
country: Croatia
facility: Klinika za psihijatriju Sveti Ivan
city: Zagreb
country: Croatia
facility: Klinika za psihijatriju Vrapce
city: Wrocław
country: Poland
facility: EMC Instytut Medyczny S.A.
state: Dolnoslaskie
city: Lublin
country: Poland
facility: Clinical Best Solutions - Lublin
state: Lubelskie
city: Łódź
country: Poland
facility: Medycyna Milorzab sp. z o.o.
state: Lódzkie
city: Łódź
country: Poland
facility: Osrodek Badan Klinicznych Appletreeclinics
state: Lódzkie
city: Warszawa
country: Poland
facility: FutureMeds Warszawa Centrum
state: Mazowieckie
city: Warszawa
country: Poland
facility: MTZ Clinical Research powered by Pratia
state: Mazowieckie
city: Warszawa
country: Poland
facility: Centrum Leczenia Zaburzen Pamieci Affidea
state: Mazowieckie
city: Katowice
country: Poland
facility: Centrum Medyczne Silmedic Sp z o o
state: Slaskie
city: Katowice
country: Poland
facility: EMC Silesia Sp. z o.o.
state: Slaskie
city: Katowice
country: Poland
facility: Neuro-Medic Janusz Zbrojkiewicz
state: Slaskie
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Dragisa Misovic Dedinje
city: Belgrade
country: Serbia
facility: Military Medical Academy, Clinic of Neurology
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia, Clinic for neurology
city: Kovin
country: Serbia
facility: Special Hospital for Psychiatric Diseases
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac, Clinic for Psychiatry
city: Niš
country: Serbia
facility: University Clinical Center Nis, Clinic for neurology
city: Novi Sad
country: Serbia
facility: Clinical Centre of Vojvodina, Clinic of Neurology
city: Vršac
country: Serbia
facility: Special Hospital for Psychiatric Diseases ''Dr Slavoljub Bakalovic''
Study officials:
References: