Frontotemporal dementia (FTD)comprises a varied group of brain abnormalities characterised by prominent changes in social behavior and personality caused by degeneration of the front part of the brain. Currently there are no FDA-approved therapies for behavioral variant FTD (bvFTD), nor are there any specific treatments that can halt or alter the course of disease progression. 

Study design

This is a multicentre study evaluating the effect of oral semaglutide in bvFTD. Oral semaglutide is a tablet approved for the treatment of diabetes. The aim of the study is to evaluate whether semaglutide could be used as a treatment for bvFTD, by assessing the influence of semaglutide on brain volume (measured by a scan called MRI), memory and understanding, and blood markers in FTD patients. 

Primary objective

To evaluate the change in MRI brain volume in patients receiving semaglutide versus a dummy drug (called a placebo) for 12 months 

Secondary objectives

1 – To evaluate the change in FTD clinical dementia rating and other cognitive function tests in treatment group compared with placebo groups 

2 – To evaluate blood markers in patients with bvFTD receiving oral semaglutide daily compared to placebo for 12 months. 

3 – To assess the safety and tolerability of oral semaglutide in subjects with bvFTD 

Methods

 bvFTD patients will be recruited into this study from specialist centres in the US, Canada, Europe and Australia. Patients will have an initial telephone screen, and eligible patients who agree to participate will then be invited to the research site. After obtaining written Informed Consent, all subjects will have detailed memory tests, physical and neurological examination and an MRI scan. Groups of subjects will receive oral semaglutide or placebo for 12 months. MRI scans and all other measures will be repeated after 12 months. We aim to have 126 patients who completes all the assessments.