Masupirdine treatment for agitation in Alzheimer's dementia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled study aims to evaluate the efficacy, safety, tolerability, and pharmacokinetics of masupirdine in treating agitation in individuals diagnosed with Alzheimer's type dementia. Approximately 375 participants will be enrolled across 50 centers worldwide, receiving either masupirdine or a placebo for 12 weeks. Participants will be screened for eligibility based on specific criteria, including confirmed agitation and cognitive assessment scores.

Why it matters

Who can join: the full rules

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's running

• Advanced Research Center, Inc.
  Anaheim, California, United States Recruiting
• ATP Clinical Research, Inc.
  Costa Mesa, California, United States Recruiting
• Leading Edge Research LA, LLC
  Encino, California, United States Recruiting
• Neuro Pain Medical Center
  Fresno, California, United States Recruiting
• Neurology Center of North Orange County
  Fullerton, California, United States Recruiting
• Mary S Easton Center for Alzheimer's Research and Care UCLA
  Los Angeles, California, United States Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: agitation@suven.com
• Phone: +9140 2319 3956

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.