Status:
RECRUITING
Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type
Lead Sponsor:
Suven Life Sciences Limited
Conditions:
Agitation
Alzheimer's Type Dementia
Eligibility:
All Genders
50-90 years
Phase:
PHASE3
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...
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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT05397639
Start Date
November 1 2022
End Date
December 1 2025
Last Update
May 20 2025
Active Locations (52)
Enter a location and click search to find clinical trials sorted by distance.
1
Advanced Research Center, Inc.
Anaheim, California, United States, 92805-5854
2
ATP Clinical Research, Inc.
Costa Mesa, California, United States, 92626-4607
3
Leading Edge Research LA, LLC
Encino, California, United States, 91316
4
Neuro Pain Medical Center
Fresno, California, United States, 93710-5473