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

Launched by SUVEN LIFE SCIENCES LIMITED · May 25, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called masupirdine to see if it can help reduce agitation in people with Alzheimer's disease. Agitation can include symptoms like restlessness, irritability, or aggression, which can be challenging for both patients and their families. The researchers want to find out if masupirdine is effective, safe, and well-tolerated compared to a placebo (a treatment that looks like the medication but has no active ingredients) in individuals diagnosed with Alzheimer's-related dementia.

To participate in this study, individuals must be diagnosed with Alzheimer's disease and show signs of agitation. They should have a Mini-Mental State Examination (MMSE) score between 8 and 24, which helps measure their cognitive abilities. However, those with other types of dementia or agitation caused by reasons unrelated to Alzheimer's are not eligible. Participants can expect to be part of a carefully monitored treatment process, and their health will be closely observed throughout the trial. This study is currently recruiting participants of all genders aged 18 to 100, aiming to improve the lives of those affected by Alzheimer's disease.

Gender

ALL

Eligibility 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.