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A RANDOMIZED DOUBLE BLIND CLINICAL TRIAL OF D-SERINE FOR MODIFYING PARKINSON’S DISEASE PROGRESSION
Recruiting: yes
Ethics approval body/ID: 929216
Type of study: phase II, randomized, double-blind clinical trial
Single/multi-center: multi-center
Participating countries: Norway
RATIONAL/HYPOTHESIS
D-Serine (DSR) is a naturally occurring amino acid that acts as a co-agonist at the N-methyl-D-aspartate receptor (NMDAR), a major glutamate receptor subtype, involved in synaptic plasticity. Growing evidence suggests that DSR may offer therapeutic benefits in neurodegenerative diseases. Previous studies indicate that D-serine is safe, well-tolerated, and a promising potential neuroprotective and disease-modifying treatment for Parkinson’s disease (PD). D-SPARK aims to assess whether orally administered D-Serine at a dose of 4000 mg per day (2x 2000 mg to ensure a stable bioavailability dosage throughout the day) can slow the neurodegenerative processes and lead to improvement in symptoms of people with PD.
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 enrolment.
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.
Cognitive impairment as measured by the Mini Mental Status Exam (MMSE) < 20
Weight < 45 kg
Renal dysfunction, defined as undergoing renal dialysis or having a measured or estimated glomerular filtration rate (eGFR) < 60 ml/min
OBJECTIVE
Evaluate the effect of orally administered D-serine, 2 g twice per day, versus placebo on overall symptom severity in PD.
