Effects of Exenatide on Motor Function and the Brain

Status: 
Recruiting
Clinicaltrials.gov identifier: 
NCT03659682
Sponsor: 
University of Florida
Enrollment: 
15
Study Design: 
This is a single center, open-label, single group assignment study. All participants will receive the intervention of exenatide 2mg, administered as a weekly subcutaneous injection for the 1-year duration of the study. Eligible participants are aged 40 to 77 with a diagnosis of PD within 5 years of screening and Hoehn and Yahr stage less than or equal to 2. Main exclusion criteria include individuals with previous exposure to exenatide, diagnosis of Diabetes, renal failure, “psychiatric disorders” or dementia defined as MoCA < 23. Because of the MRI imaging obtained during the study, individuals with any implantable electrical device or metallic hardware, or with significant claustrophobia, are excluded.
Rationale: 
This study’s Primary Outcome Measures are changes in four functional and structural MRI brain imaging metrics from baseline to the study end at 1 year. The four metrics being measured include: 1) free-water accumulation in the substantia nigra, 2) blood oxygen level-dependent (BOLD) signal in the posterior putamen, 3) BOLD signal in the primary motor cortex (M1), 4) BOLD signal in the supplemental motor area (SMA). Additional measures include questionnaires regarding quality of life and depression, motor and strength function tests and cognitive tests.
Comments: 
This study is unique in that it is a single-center open-label study of exenatide with only one treatment arm and no placebo arm. The lack of a placebo group for comparison of MRI metric changes from baseline to 1-year may limit the study’s ability to formulate conclusions of exenatide’s effect on brain structure and function, though it is unclear if the study team plans to compare the treatment group to pre-existing control MRIs. The small sample size also has the potential to be a constraint in finding significance of the study’s outcomes. The fact that this study’s primary outcome is change in MRI imaging measures sets it apart from concurrent GLP-1 agonist trials.