#1 Clinical Trials Search in Europe

Masupirdine

Clinical trials are investigating Masupirdine in people with agitation linked to dementia of the Alzheimer’s type. These studies look at whether Masupirdine can help reduce agitation and how well it works compared with placebo. They also measure treatment effects over time in adults who have this symptom pattern.

Table of Contents

Trial overview

The available clinical trial data show one interventional study of Masupirdine for people with agitation symptoms linked to dementia of the Alzheimer’s type.[1] This study is authorised and is designed to test whether Masupirdine can improve agitation compared with placebo.[1]

Who is being studied

The target population is patients with agitation with Dementia of the Alzheimer’s Type.[1] In simple terms, this means people who have both memory-related dementia and symptoms such as restlessness, physical aggression, motor overactivity, or verbal aggression.[1]

The trial record does not provide more detailed inclusion or exclusion rules, so the full participation criteria are not available from the source data.[1]

Treatments and comparison groups

This study compares two oral doses of Masupirdine, 50 mg and 100 mg, against placebo.[1] A placebo is a look-alike treatment with no active study drug, used so researchers can see whether the real treatment works better.[1]

The study uses an interventional design, which means researchers assign the treatment and then follow how patients respond.[1]

What the study measures

The main outcome is the change in the CMAI items score from the start of the study to Week 12.[1] CMAI is a rating tool used to measure agitation symptoms, including behaviors such as physical aggression, excessive motor activity, and verbal aggression.[1]

By measuring change over 12 weeks, the study aims to see whether Masupirdine reduces agitation symptoms more than placebo.[1]

Study design and phase

The study is a Phase 3 trial with an enrollment of 375 participants.[1] Phase 3 studies are later-stage trials that usually include more people and focus on whether a treatment works in a larger patient group.[1]

The trial status is listed as authorised, which means it has been approved to proceed in the source record.[1]

What the results may mean

If Masupirdine shows a better change in agitation scores than placebo, the study may support its use for agitation linked to Alzheimer’s-type dementia.[1] For patients and families, the key question is whether treatment can ease distressing behaviors and improve daily life over time.[1]

At this stage, the source data describe the study plan and goals, not final results.[1]

Aspect Details
Drug Name Masupirdine (SUVN-502)
Purpose Treatment of agitation in Alzheimer’s type dementia
Study Type Phase 3, double-blind, randomized, placebo-controlled
Duration 12 weeks
Dosages Tested 50 mg (low dose) and 100 mg (high dose)
Administration Oral tablet, once daily
Number of Participants Approximately 375
Study Centers Approximately 50 worldwide
Primary Outcome Measure Change in Cohen-Mansfield Agitation Inventory (CMAI) score
Secondary Outcome Measure Change in modified Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGI-C)

FAQ

  • What is being studied in Masupirdine trials? The trial is studying whether Masupirdine can reduce agitation in people with dementia of the Alzheimer's type. It compares two oral doses of Masupirdine with placebo.
  • Who can take part in the study? The study is for patients with agitation symptoms linked to dementia of the Alzheimer's type. The trial data do not list more detailed entry rules.
  • What phase is the Masupirdine study? The trial is a Phase 3 study. Phase 3 studies usually look at how well a treatment works in a larger group of people and continue to assess safety.
  • What outcome is the study measuring? The main outcome is the change in agitation scores from the start of the study to Week 12. It uses the CMAI items score aligned with agitation criteria.
  • Is Masupirdine compared with another treatment? Yes. The study compares Masupirdine 50 mg and 100 mg with placebo. Placebo is a look-alike treatment with no active study drug.

Ongoing Clinical Trials on Masupirdine

  • Study on Masupirdine for Treating Agitation in Alzheimer’s Dementia Patients

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Croatia Poland

Glossary

  • Agitation: A state of restlessness, distress, or increased movement and irritability. In this study, it refers to agitation linked to dementia.
  • Dementia of the Alzheimer's type: A brain disorder that causes memory loss and problems with thinking and daily function. The trial studies people who also have agitation.
  • Placebo: A look-alike treatment with no active study drug. It helps researchers compare whether the study drug works better than no active treatment.
  • Phase 3: A later stage of clinical research. These studies usually include more people and test how well a treatment works in real patient groups.
  • Interventional study: A study where researchers give a treatment and observe what happens. This is different from a study that only watches people without changing treatment.
  • Oral use: Taken by mouth.
  • CMAI: A rating scale used to measure agitation symptoms. It helps track changes in behaviors such as physical aggression, motor activity, and verbal aggression.
  • Baseline: The starting point before treatment begins. Researchers compare later results with the baseline to see if symptoms changed.
  • Week 12: The point 12 weeks after treatment starts. In this study, it is when the main result is measured.
  • Enrollment: The number of people planned or included in a study.

References