D-SPARK: D‑Serine to modify Parkinson's progression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

D‑SPARK is a randomized, double‑blind, placebo‑controlled Phase 2 trial in which participants receive both oral D‑serine and placebo during different parts of a 58‑week intervention period followed by a 12‑week washout. The protocol includes an initial screening and optimization of dopaminergic therapy to a stable dose before randomization, with medication adjustments allowed after 32 weeks on study drug. Efficacy signals will be compared between D‑serine and placebo treatment periods, and safety will be monitored throughout. The trial requires DaTscan confirmation of nigrostriatal denervation and enrolls people with early PD (Hoehn and Yahr <3).

Why it matters

Who can join: the full rules

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.

Where it's running

• Nevro Arendal Soerlandsklinikken
  Arendal, Agder, Norway Recruiting
• Oslo University Hospital
  Oslo, Oslo, Norway Recruiting
• Haukeland University Hospital
  Bergen, Vestland, Norway Recruiting
• Akershus University Hospital
  Lørenskog, Akershus, Norway Not yet recruiting
• Vestre Viken Hospital
  Drammen, Buskerud, Norway Not yet recruiting
• Molde Hospital
  Molde, Møre og Romsdal, Norway Not yet recruiting

Study contacts

• Study coordinator: Charalampos Tzoulis, MD, PhD
• Email: charalampos.tzoulis@helse-bergen.no
• Phone: 55975061

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.