Status:
Recruiting
Sponsor:
Stockholm Health Care Services
Enrollment:
60
Study Design:
The study is single-centre, double-blind, parallel group, randomised and placebo-controlled. The exenatide and placebo groups will receive treatment for 18 months, with the final evaluation occurring 3 months afterwards.
Rationale:
The primary outcome measure is FDG-PET analysis at baseline, 9 and 21 months. Secondary outcomes are: a. MDS-UPDRS part 3 in OFF-medication state, and accelerometer-based parameters of physical activity at baseline, 9, 18 and 21 months; b. MDS-UPDRS parts 1, 2, 3, and 4 in the ON-medication state, Hoehn and Yahr stage, levodopa equivalent daily dose, CSF and plasma parameters at baseline, 3, 6, 9, 12, 15, 18, and 21 months; c. PDQ-39, NMSQuest, ESS, MADRS at baseline, 6, 12, 19 months; d. MoCA at baseline, 9, and 21 months; e. B-SIT at baseline, 9, and 18 months.
Comments:
The target patient population for this study is those PwP in the early stages of PD, as defined by a Hoehn and Yahr score of 2 in the ON state, currently on levodopa therapy. A 3-month washout period at the end of the treatment phase is intended to minimise any symptomatic relief potentially provided by exenatide.
This study will provide analysis of changes in brain metabolism that will provide further insight to the mechanism of action of GLP-1 agonists in PD progression. In addition, it will produce further data on the clinical effect of exenatide in PD.
