Information about the drug that will be tested in the study
Is the drug already on the market for another medical condition?
Will all participants receive the same drug?
- An oral tablet of masupirdine (50 mg) daily
- An oral tablet of nasupirdine (100 mg) daily
- An oral tablet of placebo daily (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect).
Neither the participant nor their doctor will know if the person is receiving the investigational drug or the placebo.
Information about participating in the trial
What are the researchers trying to find out?
The purpose of the study is to evaluate the efficacy and safety of masupirdine for the treatment of agitation in people with dementia of the Alzheimer’s type.
How long will the treatment last?
What will your involvement entail?
During the study, participants will be asked to complete tests to assess agitation (these tests are called CMAI and mADCS-CGI-C).
Further information on the number of visits and on the list of study assessments can be obtained from the study team.
Who can participate in this study?
Who can participate in the study?
To take part in the study, participants must notably:
- Be 50 to 90 years old
- Have a diagnosis of dementia of the Alzheimer's type according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria
- Have confirmed agitation according to the IPA Consensus Provisional Definition of Agitation in Cognitive Disorders
- Have a score between 8 and 24 in the MMSE questionnaire (a test about your memory).
The above list is not exhaustive.
Who cannot participate in the study?
Exclusion criteria include:
- Any diagnosis of dementia other than related to Alzheimer's disease such as vascular dementia, frontotemporal dementia, Parkinson's disease, Dementia with Lewy Bodies
- A disease or medical condition that may interfere with the study assessments and will make the participant unsuitable for participation in or completion of the trial procedures (i.e. delirium, psychosis, psychiatric disorder, systemic infection).
The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.
Information for your doctor
Study contact information
Link to full text
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on November 2023.
This document has been reviewed by a member of the European Working Group of People with Dementia.
The pharmaceutical company running this trial has reviewed this document.