Actively Recruiting
D-SPARK: A Randomized Double Blind Clinical Trial of D-Serine for Modifying Parkinson's Disease Progression
Led by Haukeland University Hospital · Updated on 2026-06-04
100
Participants Needed
11
Research Sites
39 weeks
Total Duration
On this page
Sponsors
H
Haukeland University Hospital
Lead Sponsor
S
SPARK NS
Collaborating Sponsor
AI-Summary
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 Parkinson's 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 Parkinson's 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 Parkinson's treatment. This study may provide important insights into D-serine's potential effects on Parkinson's disease progression.
CONDITIONS
Brief Title
D-SPARK: A Clinical Trial of D-Serine for Modifying Parkinson's Disease Progression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Parkinson's disease within 5 years based on established clinical criteria
- Confirmed dopaminergic nigrostriatal denervation by DaTscan imaging
- Hoehn and Yahr score less than 3 at enrollment
- Stable optimal symptomatic Parkinson's treatment for at least 2 weeks
- Age between 40 and 80 years at enrollment
You will not qualify if you...
- Dementia or neurodegenerative disorder other than Parkinson's disease
- Atypical parkinsonism such as PSP, MSA, CBD, vascular or drug-induced parkinsonism
- Known monogenic cause of Parkinson's disease (except GBA1 variation)
- Psychiatric disorders interfering with study compliance
- Severe physical illness preventing participation
- Use of D-serine supplements within 90 days prior to enrollment
- Metabolic, neoplastic, or debilitating disorders at baseline
- Active or planned pregnancy during trial
- Cognitive impairment with MMSE score below 20
- Body weight less than 45 kg
- Urinary albumin/creatinine ratio 20 mg/mmol or higher
- Chronic kidney disease stage 3 or higher with eGFR below 60 mL/min/1.73m² at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial. Parkinson's disease treatment with dopaminergic drugs will be initiated or adjusted until an optimal, stable effect is established before proceeding.
Screening and enrollment visit
Duration - 58 weeks
Participants are randomized to receive either D-serine or placebo. Parkinson's disease medication is maintained at a stable dose for the first 32 weeks, then may be adjusted if needed. The study drug is taken for a total of 58 weeks.
Visits as scheduled throughout the 58 weeks of study drug administration
Duration - 12 weeks
After completing the treatment phase, participants stop taking the study drug and are followed for an additional 12 weeks to monitor outcomes.
Follow-up visit 12 weeks after stopping study drug
Trial Site Locations
Total: 11 locations
1
Nevro Arendal Soerlandsklinikken
Arendal, Agder, Norway, 4838
Actively Recruiting
2
Akershus University Hospital
Lørenskog, Akershus, Norway, 1478
Not Yet Recruiting
3
Vestre Viken Hospital
Drammen, Buskerud, Norway, 3004
Not Yet Recruiting
4
Molde Hospital
Molde, Møre og Romsdal, Norway, 6412
Not Yet Recruiting
5
Bodø Hospital (Nordland Hospital)
Bodø, Nordland, Norway, 8006
Not Yet Recruiting
6
Oslo University Hospital
Oslo, Oslo, Norway, 0450
Actively Recruiting
7
Haugesund Hospital
Haugesund, Rogaland, Norway, 5528
Not Yet Recruiting
8
University Hospital of North Norway
Tromsø, Troms, Norway, 9019
Not Yet Recruiting
9
Haukeland University Hospital
Bergen, Vestland, Norway, 5021
Actively Recruiting
10
Førde Hospital
Førde, Vestland, Norway, 6812
Not Yet Recruiting
11
Østfold Hospital
Sarpsborg, Østfold fylke, Norway, 1714
Not Yet Recruiting
Research Team
C
Charalampos Tzoulis, MD, PhD
H
Haakon Berven, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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