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New treatment option for Parkinson s Disease
Official title D-SPARK: A Clinical Trial of D-Serine for Modifying Parkinson's Disease Progression
ClinicalTrials.gov ID: NCT07312110
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Arendal, Agder, Norway
- Lørenskog, Akershus, Norway
- Drammen, Buskerud, Norway
- Molde, Møre og Romsdal, Norway
- Bodø, Nordland, Norway
- Oslo, Oslo, Norway
- Haugesund, Rogaland, Norway
- Tromsø, Troms, Norway
- Bergen, Vestland, Norway
- Førde, Vestland, Norway
- Sarpsborg, Østfold fylke, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Arendal, Agder, Norway; Lørenskog, Akershus, Norway; Drammen, Buskerud, Norway; Molde, Møre og Romsdal, Norway; Bodø, Nordland, Norway; Oslo, Oslo, Norway and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.