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

RecruitingPhase 2Ages 40 Years - 80 YearsAllHaukeland University Hospital
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In plain words

What the trial is, and whether it could suit you

This clinical study, designed as a randomized, double-blind, placebo-controlled trial, aims to investigate if modulation of the N-methyl-D-aspartate receptor (NMDAR) via its co-agonist D-serine has therapeutic benefits in Parkinson's disease (PD). All patients will receive both placebo and D-serine over different time periods during the study. Preclinical studies have shown that blocking glycine transporters, which elevates endogenous glycine levels, can restore NMDAR function and improve motor deficits in PD models. A clinical trial demonstrated that oral D-serine (30 mg/kg/day for 6 weeks) significantly reduced extrapyramidal and abnormal involuntary movements in PD patients compared to placebo, with improvements observed in both motor and non-motor symptoms. D-serine supplementation has shown an acceptable safety profile with doses up to 120 mg/kg showing no significant adverse effec

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * A clinical diagnosis of PD\* according to the clinically established MDS clinical diagnostic criteria for Parkinson's disease within 5 years. * \[¹²³I\]FP-CIT single photon emission CT (DaTscan) confirming dopaminergic nigrostriatal denervation. * Hoehn and Yahr score \< 3 at enrollment. * Optimal symptomatic PD treatment, not requiring adjustments, for at least 2 weeks. * Age ≥40 and ≤ 80 years at time of enrollment. Exclusion Criteria: * Dementia or neurodegenerative disorder other than PD at baseline visit. * Atypical parkinsonism (PSP, MSA, CBD vascular parkinsonism, or drug induced parkinsonism). * Any known monogenic cause of PD (GBA1 variation is accepted). * Any psychiatric disorder that would interfere with compliance in the study. * Any severe somatic illness that would make the individual unable to comply and participate in the study. * Use of D-serine supplementation within 90 days of enrolment. * Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit. * Active of planned pregnancy during trial period. * Cognitive impairment as measured by the Mini Mental Status Exam MMSE) \< 20. * Weight \< 45 kg. * Urinary albumin/creatinine ratio ≥ 20 mg/mmol at time of enrollment. * Participants will be excluded if they have CKD stage 3 or higher, defined as: * Estimated golumerular filtration rate (eGFR) \< 60 mL/min/1.73min\^2 at screening, calculated using the CKD-EPI 2021 creatinine equation.
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What it tests

  • D-serine
  • Placebo
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Where

11 sites
Nevro Arendal Soerlandsklinikken
Arendal, Norway
Akershus University Hospital
Lørenskog, Norway
Vestre Viken Hospital
Drammen, Norway
Molde Hospital
Molde, Norway
Bodø Hospital (Nordland Hospital)
Bodø, Norway
Oslo University Hospital
Oslo, Norway
Haugesund Hospital
Haugesund, Norway
University Hospital of North Norway
Tromsø, Norway

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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