Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type
Recruiting · NCT05397639 · Interventional (participants receive a specific treatment) · Lead sponsor: Suven Life Sciences Limited
View the official record on ClinicalTrials.gov →Interventions studied
Masupirdine 100 mgMasupirdine 50 mgPlacebo
What this trial is about
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.
Who can take part
Age range
50 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
44 locations listed across 9 US states.
- Advanced Research Center, Inc. - Anaheim, California, United States
- ATP Clinical Research, Inc. - Costa Mesa, California, United States
- Leading Edge Research LA, LLC - Encino, California, United States
- Neuro Pain Medical Center - Fresno, California, United States
- Neurology Center of North Orange County - Fullerton, California, United States
- Mary S Easton Center for Alzheimer's Research and Care UCLA - Los Angeles, California, United States
- Ki Health Partners, LLC - Stamford, Connecticut, United States
- Allied Biomedical Research Institute - Miami, Florida, United States
- Central Miami Medical Institute - Miami, Florida, United States
- CCM Clinical Research Group - Miami, Florida, United States
- Miami Jewish Health - Miami, Florida, United States
- Novel Clinical Research Center, LLC. - Miami, Florida, United States
- Brainstorm Research - Miami, Florida, United States
- Combined Research Orlando Phase I-IV - Orlando, Florida, United States
- Quantum Laboratories Inc - Pompano Beach, Florida, United States
- Re:Cognition Health - Chicago, Illinois, United States
- Insight Hospital and Medical Center Chicago - Chicago, Illinois, United States
- Ocean Medical Research - Toms River, New Jersey, United States
- Dent Neurologic Institute - Amherst, New York, United States
- Velocity Clinical Research, Syracuse - East Syracuse, New York, United States
- Velocity Clinical Research, Cleveland - Beachwood, Ohio, United States
- Ralph H. Johnson VA Health Care System - Charleston, South Carolina, United States
- Midlands Neurology and Pain Associates - Columbia, South Carolina, United States
- Gadolin Research - Beaumont, Texas, United States
- Re:Cognition Health - Fort Worth, Texas, United States
- Baylor College of Medicine - Houston, Texas, United States
- Clinical Trial Network - Houston, Texas, United States
- Clinical Hospital Center Dragisa Misovic Dedinje - 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
- Clinical Hospital Center Rijeka - Rijeka, Croatia
- ClinHouse Centrum Medyczne - Zabrze, Poland
- Polyclinic Neuron - Zagreb, Croatia
- University Hospital Center Zagreb - Zagreb, Croatia
- Klinika za psihijatriju Vrapce - Zagreb, Croatia
- Medycyna Milorzab sp. z o.o. - Lodz, Lódzkie, Poland
- FutureMeds Warszawa Centrum - Warsaw, Masovian Voivodeship, Poland
- MTZ Clinical Research powered by Pratia - Warsaw, Masovian Voivodeship, Poland
- Centrum Leczenia Zaburzen Pamieci Affidea - Warsaw, Masovian Voivodeship, Poland
- Centrum Medyczne Silmedic Sp z o o - Katowice, Silesian Voivodeship, Poland
- EMC Silesia Sp. z o.o. - Katowice, Silesian Voivodeship, Poland
- Neuro-Medic Janusz Zbrojkiewicz - Katowice, Silesian Voivodeship, Poland