Status:
Not Yet Recruiting
Clinicaltrials.gov identifier:
Sponsor:
Oslo University Hospital
Enrollment:
120
Study Design:
The study is a double-blind, placebo-controlled, randomised 1:1, crossover, delayed start design, run in a single centre. Treatment in the first stage lasts for 2 years. This is followed by an open second stage where all participants will be on semaglutide, with treatment lasting for a further 2 years.
Rationale:
The primary outcome measure is motor function as measured by MDS-UPDRS part 3 in the OFF state at baseline and 48 months. There are no official secondary outcomes specified, although the text describes further parameters that will be assessed: a. Motor function measured by levodopa equivalent dose (LED); b. Nigrostriatal degeneration measured by changes in DATscan; c. Cognitive function measured by MME and MOCA; d. Quality of life measured by EQFDQ and PDQ; e. Non-motor symptoms measured by NMSS; f. Inflammatory markers measured in blood and CSF. Each of the above will be measured at baseline, 12, 24, 36 and 48 months. In addition, the blood and CSF samples will be used to assess the permeability of the blood brain barrier to semaglutide.
Comments:
The target population for this trial is patients newly diagnosed with PD, confirmed by DaTscan. Enrolment must happen within a year of diagnosis. The eligible age range is 40-75, narrower than many other PD trials. Ozempic is available in 2 doses, 0.5mg and 1.0mg; the Oslo PD study will test the higher dose.
Given the comparatively slow degeneration rate in PD, the treatment periods of 2 years each are a positive feature of this study. Assuming no other confounding factors, the first 2-year block should reach enough decline in the placebo group to enable a meaningful comparison with the active drug.
Semaglutide is the first GLP-1 agonist to be taken orally. This could be a strong competitive edge if the efficacy of GLP-1 agonists in PD should prove to be a class effect with similar outcomes.
