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

January 16, 2024 updated by: Suven Life Sciences Limited

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study medication will be administered orally once-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.

Study Type

Interventional

Enrollment (Estimated)

375

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Croatia
      • Rijeka, Croatia, 51000
        • Recruiting
        • Clinical Hospital Center Rijeka
        • Contact:
          • Clinical Research Site
      • Zagreb, Croatia, 10000
        • Recruiting
        • Polyclinic Neuron
        • Contact:
          • Clinical Research Site
      • Zagreb, Croatia, 10000
        • Recruiting
        • University Hospital Center Zagreb
        • Contact:
          • Clinical Research Site
      • Zagreb, Croatia, 10090
        • Recruiting
        • Klinika za psihijatriju Sveti Ivan
        • Contact:
          • Clinical Research Site
      • Zagreb, Croatia, 10090
        • Recruiting
        • Klinika za psihijatriju Vrapce
        • Contact:
          • Clinical Research Site
  • Poland
    • Dolnoslaskie
      • Wrocław, Dolnoslaskie, Poland, 50-220
        • Recruiting
        • EMC Instytut Medyczny S.A.
        • Contact:
          • Clinical Research Site
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-078
        • Recruiting
        • Clinical Best Solutions - Lublin
        • Contact:
          • Clinical Research Site
    • Lódzkie
      • Łódź, Lódzkie, Poland, 90-349
        • Recruiting
        • Osrodek Badan Klinicznych Appletreeclinics
        • Contact:
          • Clinical Research Site
      • Łódź, Lódzkie, Poland, 93-118
        • Recruiting
        • Medycyna Milorzab sp. z o.o.
        • Contact:
          • Clinical Research Site
    • Malopolskie
      • Kraków, Malopolskie, Poland, 31-505
        • Recruiting
        • Krakowska Akademia Neurologii Sp. z o.o.
        • Contact:
          • Clinical Research Site
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 00-215
        • Recruiting
        • FutureMeds Warszawa Centrum
        • Contact:
          • Clinical Research Site
    • Slaskie
      • Katowice, Slaskie, Poland, 40-282
        • Recruiting
        • Centrum Medyczne Silmedic Sp z o o
        • Contact:
          • Clinical Research Site
      • Katowice, Slaskie, Poland, 40-650
        • Recruiting
        • Novo-Med Zielinski i wsp. Sp.J.
        • Contact:
          • Clinical Research Site
      • Katowice, Slaskie, Poland, 40-686
        • Recruiting
        • Neuro-Medic Janusz Zbrojkiewicz
        • Contact:
          • Clinical Research Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinical Hospital Center Dragisa Misovic Dedinje
        • Contact:
          • Clinical Research Site
      • Belgrade, Serbia, 11000
        • Recruiting
        • University Clinical Center of Serbia, Clinic for Neurology
        • Contact:
          • Clinical Research Site
      • Belgrade, Serbia, 11000
        • Recruiting
        • Military Medical Academy, Clinic of Neurology
        • Contact:
          • Clinical Research Site
      • Kovin, Serbia, 26220
        • Recruiting
        • Special Hospital for Psychiatric Diseases
        • Contact:
          • Clinical Research Site
      • Kragujevac, Serbia, 34000
        • Recruiting
        • University Clinical Center Kragujevac, Clinic for Psychiatry
        • Contact:
          • Clinical Research Site
      • Niš, Serbia, 18000
        • Recruiting
        • University Clinical Center Nis, Clinic for neurology
        • Contact:
          • Clinical Research Site
      • Novi Sad, Serbia, 21000
        • Recruiting
        • Clinical Centre of Vojvodina, Clinic of Neurology
        • Contact:
          • Clinical Research Site
      • Vršac, Serbia, 26300
        • Recruiting
        • Special Hospital for Psychiatric Diseases ''Dr Slavoljub Bakalovic''
        • Contact:
          • Clinical Research Site
  • United States
    • California
      • Anaheim, California, United States, 92805-5854
        • Recruiting
        • Advanced Research Center, Inc.
        • Contact:
          • Clinical Research Site
      • Costa Mesa, California, United States, 92626-4607
        • Recruiting
        • ATP Clinical Research, Inc.
        • Contact:
          • Clinical Research Site
      • Fresno, California, United States, 93710-5473
        • Recruiting
        • Neuro Pain Medical Center
        • Contact:
          • Clinical Research Site
      • Fullerton, California, United States, 92835-1040
        • Recruiting
        • Neurology Center of North Orange County
        • Contact:
          • Clinical Research Site
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Mary S Easton Center for Alzheimer's Research and Care UCLA
        • Contact:
          • Clinical Research Site
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Recruiting
        • Ki Health Partners, LLC
        • Contact:
          • Clinical Research Site
    • Florida
      • Miami, Florida, United States, 33122-1335
        • Recruiting
        • Central Miami Medical Institute
        • Contact:
          • Clinical Research Site
      • Miami, Florida, United States, 33125-2607
        • Recruiting
        • Allied Biomedical Research Institute
        • Contact:
          • Clinical Research Site
      • Miami, Florida, United States, 33133
        • Recruiting
        • CCM Clinical Research Group
        • Contact:
          • Clinical Research Site
      • Miami, Florida, United States, 33143
        • Recruiting
        • Novel Clinical Research Center, LLC.
        • Contact:
          • Clinical Research Site
      • Miami, Florida, United States, 33176
        • Recruiting
        • Brainstorm Research
        • Contact:
          • Clinical Research Site
      • Miami, Florida, United States, 33137
        • Recruiting
        • Miami Jewish Health
        • Contact:
          • Clinical Research Site
      • Orlando, Florida, United States, 32807
        • Recruiting
        • Combined Research Orlando Phase I-IV
        • Contact:
          • Clinical Research Site
      • Pompano Beach, Florida, United States, 33064
        • Recruiting
        • Quantum Laboratories Inc
        • Contact:
          • Clinical Research Site
    • New York
      • Amherst, New York, United States, 14226
        • Recruiting
        • Dent Neurologic Institute
        • Contact:
          • Clinical Research Site
      • Commack, New York, United States, 11725-2808
        • Recruiting
        • North Suffolk Neurology
        • Contact:
          • Clinical Research Site
      • New Windsor, New York, United States, 12553
        • Recruiting
        • Mid Hudson Medical Research, PLLC
        • Contact:
          • Clinical Research Site
      • Staten Island, New York, United States, 10312-6501
        • Recruiting
        • Richmond Behavioral Associates
        • Contact:
          • Clinical Research Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • NeuroScience Research Center, LLC
        • Contact:
          • Clinical Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29401-1113
        • Recruiting
        • Ralph H. Johnson VA Health Care System
        • Contact:
          • Clinical Research Site
    • Texas
      • Houston, Texas, United States, 77074
        • Recruiting
        • Clinical Trial Network
        • Contact:
          • Clinical Research Site
      • Houston, Texas, United States, 77030-4202
        • Recruiting
        • Baylor College of Medicine
        • Contact:
          • Clinical Research Site

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.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Dose Masupirdine Arm
Tablet
Drug: Masupirdine 50 mg
Tablet, Once Daily
Other Names:
  • SUVN-502
Experimental: High Dose Masupirdine Arm
Tablet
Drug: Masupirdine 100 mg
Tablet, Once Daily
Other Names:
  • SUVN-502
Placebo Comparator: Placebo
Tablet
Drug: Placebo
Matching Placebo Tablet, Once Daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohen-Mansfield Agitation Inventory (CMAI)
Time Frame: From Baseline to Week 12 visit
Change in CMAI items score aligning to the International Psychogeriatric Association (IPA) agitation criteria domains (physical aggression, excessive motor activity, and verbal aggression). CMAI is a validated 29-item questionnaire to assess agitation. Each item is rated on a 7-point scale ranging from 1 "Never" to 7 "Several times per hour". Higher scores indicate worsening agitation.
From Baseline to Week 12 visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGI-C)
Time Frame: From Baseline to Week 12 visit
Change in mADCS-CGI-C. The mADCS-CGI-C is a modification of the ADCS-CGI-C instrument that focuses specifically on agitation. It is a 7-point Likert scale that ranges from marked improvement scored as 1 to marked worsening scored as 7. The range is from 1 to 7. Higher scores indicate worsening agitation.
From Baseline to Week 12 visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

May 25, 2022

First Submitted That Met QC Criteria

May 25, 2022

First Posted (Actual)

May 31, 2022

Study Record Updates

Last Update Posted (Estimated)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP3S1502HT6
  • 2021-003405-22 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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