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NCT Number: NCT05397639

Masupirdine for the Treatment of Agitation in 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.

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Key information

Conditions

Agitation Aberrant Motor Behavior in Dementia Alzheimer's Type Dementia Behavior Behavioral Symptoms Dyskinesias Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Hospital Center Rijeka, Rijeka, Croatia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Masupirdine 50 mg

Drug

Tablet, Once Daily

Other names: SUVN-502

Masupirdine 100 mg

Drug

Tablet, Once Daily

Other names: SUVN-502

Placebo

Drug

Matching Placebo Tablet, Once Daily

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

+9140 2319 3956

Sponsors and collaborators

Lead sponsor

Suven Life Sciences Limited

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 31, 2022
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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