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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05397639
Recruitment Status : Recruiting
First Posted : May 31, 2022
Last Update Posted : March 16, 2023
Sponsor:
Information provided by (Responsible Party):
Suven Life Sciences Limited

Study Description
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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.

Condition or disease Intervention/treatment Phase
Agitation Alzheimer's Type Dementia Drug: Masupirdine 50 mg Drug: Masupirdine 100 mg Drug: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-Blind
Primary Purpose: Treatment
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
Actual Study Start Date : November 1, 2022
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Low Dose Masupirdine Arm
Tablet
 Drug: Masupirdine 50 mg
Tablet, Once Daily
Other Name: SUVN-502
Experimental: High Dose Masupirdine Arm
Tablet
 Drug: Masupirdine 100 mg
Tablet, Once Daily
Other Name: SUVN-502
Placebo Comparator: Placebo
Tablet
 Drug: Placebo
Matching Placebo Tablet, Once Daily


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05397639


Contacts
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Contact: Study Contact +9140 2319 3956 agitation@suven.com

Locations
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Sponsors and Collaborators
Suven Life Sciences Limited
More Information
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Responsible Party: Suven Life Sciences Limited
ClinicalTrials.gov Identifier: NCT05397639    
Other Study ID Numbers: CTP3S1502HT6
2021-003405-22 ( EudraCT Number )
First Posted: May 31, 2022    Key Record Dates
Last Update Posted: March 16, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suven Life Sciences Limited:
Masupirdine
SUVN-502
Phase 3
Agitation
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
 Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
1-((2-bromophenyl)sulfonyl)-5-methoxy-3-((4-methyl-1-piperazinyl)methyl)-1H-indole dimesylate monohydrate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs