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

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.

Interventions

• Masupirdine 50 mg · DRUG

  Tablet, Once Daily

• Masupirdine 100 mg · DRUG

  Tablet, Once Daily

• Placebo · DRUG

  Matching Placebo Tablet, Once Daily

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (44)

• Advanced Research Center, Inc., Anaheim, California · RECRUITING
• ATP Clinical Research, Inc., Costa Mesa, California · RECRUITING
• Leading Edge Research LA, LLC, Encino, California · RECRUITING
• Neuro Pain Medical Center, Fresno, California · RECRUITING
• Neurology Center of North Orange County, Fullerton, California · RECRUITING
• Mary S Easton Center for Alzheimer's Research and Care UCLA, Los Angeles, California · RECRUITING
• Ki Health Partners, LLC, Stamford, Connecticut · RECRUITING
• Allied Biomedical Research Institute, Miami, Florida · RECRUITING
• Central Miami Medical Institute, Miami, Florida · RECRUITING
• CCM Clinical Research Group, Miami, Florida · RECRUITING
• Miami Jewish Health, Miami, Florida · RECRUITING
• Novel Clinical Research Center, LLC., Miami, Florida · RECRUITING
• Brainstorm Research, Miami, Florida · RECRUITING
• Combined Research Orlando Phase I-IV, Orlando, Florida · RECRUITING
• Quantum Laboratories Inc, Pompano Beach, Florida · RECRUITING
• Re:Cognition Health, Chicago, Illinois · RECRUITING
• Insight Hospital and Medical Center Chicago, Chicago, Illinois · RECRUITING
• Ocean Medical Research, Toms River, New Jersey · RECRUITING
• Dent Neurologic Institute, Amherst, New York · RECRUITING
• Velocity Clinical Research, Syracuse, East Syracuse, New York · RECRUITING
• Velocity Clinical Research, Cleveland, Beachwood, Ohio · RECRUITING
• Ralph H. Johnson VA Health Care System, Charleston, South Carolina · RECRUITING
• Midlands Neurology and Pain Associates, Columbia, South Carolina · RECRUITING
• Gadolin Research, Beaumont, Texas · RECRUITING
• Re:Cognition Health, Fort Worth, Texas · RECRUITING
• Baylor College of Medicine, Houston, Texas · RECRUITING
• Clinical Trial Network, Houston, Texas · RECRUITING
• Clinical Hospital Center Rijeka, Rijeka, Croatia · RECRUITING
• Polyclinic Neuron, Zagreb, Croatia · RECRUITING
• University Hospital Center Zagreb, Zagreb, Croatia · RECRUITING
• Klinika za psihijatriju Vrapce, Zagreb, Croatia · RECRUITING
• Medycyna Milorzab sp. z o.o., Lodz, Lódzkie, Poland · RECRUITING
• FutureMeds Warszawa Centrum, Warsaw, Masovian Voivodeship, Poland · RECRUITING
• MTZ Clinical Research powered by Pratia, Warsaw, Masovian Voivodeship, Poland · RECRUITING
• Centrum Leczenia Zaburzen Pamieci Affidea, Warsaw, Masovian Voivodeship, Poland · RECRUITING
• Centrum Medyczne Silmedic Sp z o o, Katowice, Silesian Voivodeship, Poland · RECRUITING
• EMC Silesia Sp. z o.o., Katowice, Silesian Voivodeship, Poland · RECRUITING
• Neuro-Medic Janusz Zbrojkiewicz, Katowice, Silesian Voivodeship, Poland · RECRUITING
• ClinHouse Centrum Medyczne, Zabrze, Poland · RECRUITING
• Clinical Hospital Center Dragisa Misovic Dedinje, Belgrade, Serbia · RECRUITING
• Special Hospital for Psychiatric Diseases, Kovin, Serbia · RECRUITING
• University Clinical Center Kragujevac, Clinic for Psychiatry, Kragujevac, Serbia · RECRUITING
• University Clinical Center Nis, Clinic for neurology, Niš, Serbia · RECRUITING
• Clinical Centre of Vojvodina, Clinic of Neurology, Novi Sad, Serbia · RECRUITING