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

What Was Tested

In this phase 2 trial, researchers set out to test NAD+ for parkinson's disease.

It had three arms (groups): Placebo (placebo comparator), one (experimental) and one (experimental).

Placebo, no active ingredients. Administered in tablet form twice daily for the duration of the trial (12 weeks).

The registry classes the interventions as dietary supplement and other.

More on the Plan

Individuals with PD (n = 80) will be recruited starting November 2022.

Who Took Part

Enrollment: 81 actual participants took part.

It was open to people of any sex aged from 40 years up to 100 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got NAD+ and who got the comparison, which limits bias.

Groups ran in parallel: each of the parkinson's disease participants stayed in one arm throughout.

As a double-blind NAD+ study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2023-01-23 with completion listed for 2025-04-22.

It ran at 1 site in Norway.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Cerebral NAD levels measured by 31P-MRS (time frame: 12 weeks for primary analysis. 4, 8 and 12 weeks for secondary analysis).

It also tracked 1 secondary outcome, for example CSF NAD or other metabolite of the NAD metabolome, measured by LC-MS.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of NAD+ in 81 people with parkinson's disease.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, Parkinson's disease research.