RECRUITING

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

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Conditions

AgitationAlzheimer's Type DementiaMasupirdineSUVN-502Phase 3

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Masupirdine (SUVN-502) for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type

Quick Facts

Study Start:2022-11-01
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05397639

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has a diagnosis of dementia of the Alzheimer's type according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria.
  2. * Has confirmed agitation using the IPA Consensus Provisional Definition of Agitation in Cognitive Disorders.
  3. * Has a score between 8 and 24 (both inclusive) on Mini-Mental State Examination (MMSE).
  1. * Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, parkinson's disease, lewy body disease, frontotemporal dementia)
  2. * 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).
  3. * Participant (or caregiver) is deemed otherwise ineligible for participation in this study in the investigator's judgement.

Contacts and Locations

Study Contact

Study Contact
CONTACT
+9140 2319 3956
agitation@suven.com

Study Locations (Sites)

Advanced Research Center, Inc.
Anaheim, California, 92805-5854
United States
ATP Clinical Research, Inc.
Costa Mesa, California, 92626-4607
United States
Leading Edge Research LA, LLC
Encino, California, 91316
United States
Neuro Pain Medical Center
Fresno, California, 93710-5473
United States
Neurology Center of North Orange County
Fullerton, California, 92835-1040
United States
Mary S Easton Center for Alzheimer's Research and Care UCLA
Los Angeles, California, 90095
United States
Ki Health Partners, LLC
Stamford, Connecticut, 06905
United States
ClinCloud, LLC
Maitland, Florida, 32751
United States
Allied Biomedical Research Institute
Miami, Florida, 33125-2607
United States
Central Miami Medical Institute
Miami, Florida, 33125
United States
CCM Clinical Research Group
Miami, Florida, 33133
United States
Miami Jewish Health
Miami, Florida, 33137
United States
Novel Clinical Research Center, LLC.
Miami, Florida, 33143
United States
Brainstorm Research
Miami, Florida, 33176
United States
Combined Research Orlando Phase I-IV
Orlando, Florida, 32807
United States
Quantum Laboratories Inc
Pompano Beach, Florida, 33064
United States
Re:Cognition Health
Chicago, Illinois, 60611
United States
Insight Hospital and Medical Center Chicago
Chicago, Illinois, 60616
United States
Ocean Medical Research
Toms River, New Jersey, 08755
United States
Dent Neurologic Institute
Amherst, New York, 14226
United States
Regional Neurological Associates
Bronx, New York, 10466
United States
Velocity Clinical Research, Syracuse
East Syracuse, New York, 13057
United States
Velocity Clinical Research, Cleveland
Beachwood, Ohio, 44122
United States
Ralph H. Johnson VA Health Care System
Charleston, South Carolina, 29401-1113
United States
Midlands Neurology and Pain Associates
Columbia, South Carolina, 29205
United States
Gadolin Research
Beaumont, Texas, 77702
United States
Re:Cognition Health
Fort Worth, Texas, 76104
United States
Baylor College of Medicine
Houston, Texas, 77030-4202
United States
Clinical Trial Network
Houston, Texas, 77074
United States

Collaborators and Investigators

Sponsor: Suven Life Sciences Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-01
Study Completion Date2025-01

Study Record Updates

Study Start Date2022-11-01
Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

  • Masupirdine
  • SUVN-502
  • Phase 3
  • Agitation

Additional Relevant MeSH Terms

  • Agitation
  • Alzheimer's Type Dementia