N-DOSE: A Dose Optimization Trial of Nicotinamide Riboside in Parkinson's Disease

Plain-language summary

This study investigates the most suitable dose of the supplement Nicotinamide Riboside in people with Parkinson's disease and uses a placebo for comparison. People aged 40 and older with a diagnosis of idiopathic Parkinson's disease who were suitable for certain examinations could take part. The study was carried out in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Haukeland University Hospital

Intervention

Nicotinamide Riboside, Placebo

Start date

1/23/2023

Estimated completion

4/22/2025

Countries

Norway

Related genes

Locations

• Bergen, Norway

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Dementia or other neurodegenerative disorder at baseline visit.
* Diagnosed with atypical parkinsonism (progressive supranuclear palsy (PSP), multiple system atrophy (MSA), corticobasal degeneration (CBD)) or vascular parkinsonism.
* Any psychiatric disorder that would interfere with compliance in the study.
* Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit.
* Use of high dose vitamin B3 supplementation within 30 days of enrollment.