D-serine for Parkinson's (D-SPARK, NCT07312110)
Slow Parkinson degeneration using Dserine
- Trial ID
- NCT07312110
- Official Title
- D-SPARK: A Randomized Double Blind Clinical Trial of D-Serine for Modifying Parkinson's Disease Progression
- Study Acronym
- D-SPARK
- Goal
- Slow Parkinson degeneration using Dserine
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Haukeland University Hospital
- Study Type
- INTERVENTIONAL
- Enrollment
- 100 participants
- Conditions
- Parkinson s Disease, Parkinson Disease (PD)
- Interventions
- D-serine, Placebo
Summary For Families
The goal is to find out whether D-serine can slow Parkinson's progression by boosting glutamate-driven synaptic function and helping protect neurons, not just treating symptoms. D-serine is a natural co-agonist at NMDA receptors, it enhances NMDA receptor signaling to support synaptic plasticity and neuronal health, and it will be tested against placebo while participants stay on stable Parkinson's meds. The trial seeks people 40 to 80 years old diagnosed within the last 5 years with DaTscan-confirmed PD and Hoehn and Yahr under 3, on stable symptomatic treatment; dementia, atypical parkinsonism, significant kidney disease, recent D-serine use, and other serious medical or psychiatric issues are exclusions.
Locations
- Nevro Arendal Soerlandsklinikken, Arendal, Agder, Norway
- Akershus University Hospital, Lørenskog, Akershus, Norway
- Vestre Viken Hospital, Drammen, Buskerud, Norway
- Molde Hospital, Molde, Møre og Romsdal, Norway
- Bodø Hospital (Nordland Hospital), Bodø, Nordland, Norway
- Oslo University Hospital, Oslo, Oslo, Norway
- Haugesund Hospital, Haugesund, Rogaland, Norway
- University Hospital of North Norway, Tromsø, Troms, Norway
- Haukeland University Hospital, Bergen, Vestland, Norway
- Førde Hospital, Førde, Vestland, Norway
- Østfold Hospital, Sarpsborg, Østfold fylke, Norway
Frequently Asked Questions
- What is this trial testing?
- This trial is studying D-serine. The goal is to find out whether D-serine can slow Parkinson's progression by boosting glutamate-driven synaptic function and helping protect neurons, not just treating symptoms. D-serine is a natural co-agonist at NMDA receptors, it enhances NMDA receptor signaling to support synaptic plasticity and neuronal health, and it will be tested against placebo while participants stay on stable Parkinson's meds. The trial seeks people 40 to 80 years old diagnosed within the last 5 years with DaTscan-confirmed PD and Hoehn and Yahr under 3, on stable symptomatic treatment; dementia, atypical parkinsonism, significant kidney disease, recent D-serine use, and other serious medical or psychiatric issues are exclusions.
- Who can participate?
- Participants must be between 40 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 11 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 2 years and 1 month.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is a crossover trial: instead of staying in one group, you move through a sequence of assignments, so you receive the active treatment during at least one period of the study. It also includes a placebo or sham phase, so you would be on that during another period. Ask the coordinator for the exact sequence and how long each phase lasts.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: PET scan (minimally invasive); Questionnaires & surveys (non-invasive); Thinking & memory tests (non-invasive). Confirm the full schedule with the study coordinator.
- Is there a medication washout in this trial?
- Yes — after the 58 week treatment period participants will stop the study drug and have a 12 week washout period.