In short
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.
Key points
- Clinical trials of Masupirdine are studying agitation in people with dementia of the Alzheimer's type. The main study is a Phase 3 trial with 375 planned participants. It compares two oral doses of Masupirdine, 50 mg and 100 mg, with placebo. The main goal is to see whether agitation scores improve by Week 12. The study measures change in CMAI items score linked to agitation behaviors such as physical aggression, excessive motor activity, and verbal aggression.
At a glance
- 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)
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. This study is authorised and is designed to test whether Masupirdine can improve agitation compared with placebo.
Who is being studied
The target population is patients with agitation with Dementia of the Alzheimer's Type. In simple terms, this means people who have both memory-related dementia and symptoms such as restlessness, physical aggression, motor overactivity, or verbal aggression.
The trial record does not provide more detailed inclusion or exclusion rules, so the full participation criteria are not available from the source data.
Treatments and comparison groups
This study compares two oral doses of Masupirdine, 50 mg and 100 mg, against placebo. A placebo is a look-alike treatment with no active study drug, used so researchers can see whether the real treatment works better.
The study uses an interventional design, which means researchers assign the treatment and then follow how patients respond.
What the study measures
The main outcome is the change in the CMAI items score from the start of the study to Week 12. CMAI is a rating tool used to measure agitation symptoms, including behaviors such as physical aggression, excessive motor activity, and verbal aggression.
By measuring change over 12 weeks, the study aims to see whether Masupirdine reduces agitation symptoms more than placebo.
Study design and phase
The study is a Phase 3 trial with an enrollment of 375 participants. Phase 3 studies are later-stage trials that usually include more people and focus on whether a treatment works in a larger patient group.
The trial status is listed as authorised, which means it has been approved to proceed in the source record.
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. For patients and families, the key question is whether treatment can ease distressing behaviors and improve daily life over time.
At this stage, the source data describe the study plan and goals, not final results.