Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type
- Conditions
- AgitationAlzheimer's Type Dementia
- Interventions
- Drug: Masupirdine 50 mgDrug: PlaceboDrug: Masupirdine 100 mg
- Registration Number
- NCT05397639
- Lead Sponsor
- Suven Life Sciences Limited
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 375
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low Dose Masupirdine Arm Masupirdine 50 mg Tablet Placebo Placebo Tablet High Dose Masupirdine Arm Masupirdine 100 mg Tablet
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGI-C) From Baseline to Week 12 visit 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.
Trial Locations
- Locations (51)
Centrum Medyczne Silmedic Sp z o o
๐ต๐ฑKatowice, Slaskie, Poland
Neuro-Medic Janusz Zbrojkiewicz
๐ต๐ฑKatowice, Slaskie, Poland
Ocean Medical Research
๐บ๐ธToms River, New Jersey, United States
Military Medical Academy, Clinic of Neurology
๐ท๐ธBelgrade, Serbia
Clinical Hospital Center Rijeka
๐ญ๐ทRijeka, Croatia
Clinical Hospital Center Dragisa Misovic Dedinje
๐ท๐ธBelgrade, Serbia
Special Hospital for Psychiatric Diseases ''Dr Slavoljub Bakalovic''
๐ท๐ธVrลกac, Serbia
Novel Clinical Research Center, LLC.
๐บ๐ธMiami, Florida, United States
Brainstorm Research
๐บ๐ธMiami, Florida, United States
University Clinical Center of Serbia, Clinic for neurology
๐ท๐ธBelgrade, Serbia
Advanced Research Center, Inc.
๐บ๐ธAnaheim, California, United States
Neurology Center of North Orange County
๐บ๐ธFullerton, California, United States
ATP Clinical Research, Inc.
๐บ๐ธCosta Mesa, California, United States
Leading Edge Research LA, LLC
๐บ๐ธEncino, California, United States
Neuro Pain Medical Center
๐บ๐ธFresno, California, United States
Mary S Easton Center for Alzheimer's Research and Care UCLA
๐บ๐ธLos Angeles, California, United States
Ki Health Partners, LLC
๐บ๐ธStamford, Connecticut, United States
ClinCloud, LLC
๐บ๐ธMaitland, Florida, United States
Allied Biomedical Research Institute
๐บ๐ธMiami, Florida, United States
Central Miami Medical Institute
๐บ๐ธMiami, Florida, United States
CCM Clinical Research Group
๐บ๐ธMiami, Florida, United States
Miami Jewish Health
๐บ๐ธMiami, Florida, United States
Quantum Laboratories Inc
๐บ๐ธPompano Beach, Florida, United States
Re:Cognition Health
๐บ๐ธFort Worth, Texas, United States
Insight Hospital and Medical Center Chicago
๐บ๐ธChicago, Illinois, United States
Dent Neurologic Institute
๐บ๐ธAmherst, New York, United States
Velocity Clinical Research, Syracuse
๐บ๐ธEast Syracuse, New York, United States
Velocity Clinical Research, Cleveland
๐บ๐ธBeachwood, Ohio, United States
Baylor College of Medicine
๐บ๐ธHouston, Texas, United States
Midlands Neurology and Pain Associates
๐บ๐ธColumbia, South Carolina, United States
Gadolin Research
๐บ๐ธBeaumont, Texas, United States
Clinical Trial Network
๐บ๐ธHouston, Texas, United States
Polyclinic Neuron
๐ญ๐ทZagreb, Croatia
Klinika za psihijatriju Sveti Ivan
๐ญ๐ทZagreb, Croatia
University Hospital Center Zagreb
๐ญ๐ทZagreb, Croatia
Klinika za psihijatriju Vrapce
๐ญ๐ทZagreb, Croatia
EMC Instytut Medyczny S.A.
๐ต๐ฑWrocลaw, Dolnoslaskie, Poland
Clinical Best Solutions - Lublin
๐ต๐ฑLublin, Lubelskie, Poland
Medycyna Milorzab sp. z o.o.
๐ต๐ฑลรณdลบ, Lรณdzkie, Poland
FutureMeds Warszawa Centrum
๐ต๐ฑWarszawa, Mazowieckie, Poland
Osrodek Badan Klinicznych Appletreeclinics
๐ต๐ฑลรณdลบ, Lรณdzkie, Poland
MTZ Clinical Research powered by Pratia
๐ต๐ฑWarszawa, Mazowieckie, Poland
EMC Silesia Sp. z o.o.
๐ต๐ฑKatowice, Slaskie, Poland
Centrum Leczenia Zaburzen Pamieci Affidea
๐ต๐ฑWarszawa, Mazowieckie, Poland
Special Hospital for Psychiatric Diseases
๐ท๐ธKovin, Serbia
University Clinical Center Kragujevac, Clinic for Psychiatry
๐ท๐ธKragujevac, Serbia
University Clinical Center Nis, Clinic for neurology
๐ท๐ธNiลก, Serbia
Clinical Centre of Vojvodina, Clinic of Neurology
๐ท๐ธNovi Sad, Serbia
Regional Neurological Associates
๐บ๐ธBronx, New York, United States
Combined Research Orlando Phase I-IV
๐บ๐ธOrlando, Florida, United States
Ralph H. Johnson VA Health Care System
๐บ๐ธCharleston, South Carolina, United States