NCT05589766CompletedPhase 2
N-DOSE: A Dose Optimization Trial of Nicotinamide Riboside in Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 8 Jul 2025
Brief summary (registry, in English)
N-DOSE is a double-blinded placebo-controlled randomized trial aiming to determine the optimal biological dose (OBD) of nicotinamide riboside (NR), in individuals with Parkinson's disease (PD). The investigators recently reported the NADPARK study (ClinicalTrials.gov: NCT03816020), a phase I randomized, double-blinded trial, assessing the tolerability, cerebral bioavailability and molecular effects of NR therapy, 1000mg daily, in PD. The NADPARK study showed that NR 1000mg daily was well tolerated and led to a significant, but variable, increase in cerebral NAD (nicotinamide adenine dinucleotide) levels (measured by 31phosphorous magnetic resonance spectroscopy, 31P-MRS) and related metabolites in the cerebrospinal fluid (CSF). NR recipients showing increased brain NAD levels exhibited altered cerebral metabolism, measured by 18fluoro-deoxyglucose positron emission tomography (FDG-PET), and this was associated with mild clinical improvement. The results of the NADPARK trial nominate NR as a potential neuroprotective therapy for PD, warranting further investigation in larger trials. The investigators recently conducted the NR-SAFE safety trial comparing 3000mg NR to placebo in 20 participants with PD over 4 weeks (NCT: NCT05344404) which showed no moderate or severe adverse events, and no signs of acute toxicity. Due to the variability in response to NR in the NADPARK trial, the N-DOSE study will investigate the response to escalating doses of NR from 1000 mg to 3000 mg over 12 weeks, in order to ascertain if NR dose escalation beyond 1000 mg per day is biologically meaningful in Parkinson's disease.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 81 (actual)
- First submitted
- 13 Oct 2022
- Start date
- 23 Jan 2023
- Primary completion date
- 22 Apr 2025
- Lead sponsor
- Haukeland University Hospital
- Diseases
- Parkinson disease
- NCT number
- NCT05589766
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 81
- From 23 Jan 2023 to the primary completion date, 22 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Dementia or other neurodegenerative disorder at baseline visit.
- Any psychiatric disorder that would interfere with compliance in the study.
- Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit.
Other
- Diagnosed with atypical parkinsonism (progressive supranuclear palsy (PSP), multiple system atrophy (MSA), corticobasal degeneration (CBD)) or vascular parkinsonism.
- Use of high dose vitamin B3 supplementation within 30 days of enrollment.
Who the study is looking for
- Clinically established diagnosis of idiopathic PD according to the MDS criteria.
- 123I-Ioflupane dopamine transporter imaging (DAT-scan) confirming nigrostriatal degeneration.
- Hoehn and Yahr score \< 4 at enrolment.
- Age ≥ 40 years at the time of enrollment.
- Able to undergo lumbar punction.
- Able to undergo MRI.
Age in the registry: 40 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Haukeland University Hospital Coordinator of this site? Confirm its status | Bergen | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.