Open Actively Recruiting

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

About

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
50 Years
Maximum Age
90 Years

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.

Join this Trial

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Study Stats
Protocol No.
22-001237
Category
Neurology
Contact
LAUREN GARCIA
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05397639
For detailed technical eligibility, visit ClinicalTrials.gov.