D-SPARK A Phase 2 Randomized, Double-Blind, Placebo-Controlled Crossover Trial of D-Serine Supplementation to Slow Parkinsons Disease Progression in Adults Aged 40 to 80

What this Trial Is About

Researchers are evaluating whether D-serine, a co-agonist of the N-methyl-D-aspartate receptor NMDAR, can improve symptoms and slow progression in Parkinsons disease PD. This randomized, double-blind, placebo-controlled trial involves 100 participants diagnosed with PD within the past 5 years. The study aims to measure changes in clinical severity using the Movement Disorder Society Unified Parkinsons Disease Rating Scale MDS-UPDRS, along with dopaminergic brain activity and cognitive function. Participants will be randomly assigned to two groups that receive both D-serine and placebo during different study periods over 58 weeks. D-serine dosing starts with 2 capsules of 500 mg twice daily in the first week and increases to 4 capsules twice daily thereafter, while placebo capsules are given similarly. After the intervention phase, a 12-week washout period will follow where the study drug is stopped, with a final visit 12 weeks after discontinuation. During the study, participants will undergo clinical evaluations including rating scales and questionnaires, cognitive testing, blood sampling, and dopamine transporter imaging via SPECT scans. Researchers will closely monitor motor and non-motor symptoms, brain dopamine function, and cognitive changes. The trial includes a screening and treatment optimization phase before randomization to ensure stable Parkinsons treatment. This study may provide important insights into D-serines potential effects on Parkinsons disease progression.

D-SPARK: A Clinical Trial of D-Serine for Modifying Parkinson's Disease Progression