NR-SAFE: Safety of High-dose Nicotinamide Riboside (NR) in Parkinson's Disease

What Was Tested

This registered not phased trial tested NAD+ for parkinson's disease.

It had two arms (groups): Nicotinamide Riboside (experimental) and Placebo (placebo comparator).

Placebo, no active ingredients. Administered in tablet form twice daily for the duration of the trial (4 weeks).

The registry classes the interventions as dietary supplement.

More on the Plan

Individuals with PD (n = 20) will be recruited starting April 2022.

Both the participants and the investigators will be blinded.

Procedures: After the baseline visit, participants will be reassessed in person on day 5, 7, 14, 21 and 28 by one of the neurologists involved in the study and by telephone on day 3 and 35 by the study nurse.

Participants will be screened for any adverse effects on each of these consultations.

Who Took Part

Enrollment: 20 actual participants took part.

It was open to people of any sex aged from 35 years with no upper age limit.

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

Examples of who could join: Age equal to or greater than 35 years and lower than 100 years at time of enrollment. Clinical diagnosis of idiopathic PD according to the MDS criteria. Hoehn and Yahr score \< 4 at enrolment.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: dementia or other neurodegenerative disorder at baseline visit; 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.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this NAD+ study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The NAD+ group and the comparison group ran side by side rather than switching.

Neither the parkinson's disease participants nor the staff measuring them knew who was on NAD+, so expectations could not easily colour the readings.

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

It started in 2022-04-29 with completion listed for 2022-07-01.

It ran at 1 site in Norway.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Incidence of treatment-associated moderate and severe adverse events (AEs) (time frame: 4 weeks).

It also tracked 3 secondary outcomes, for example Incidence of treatment-associated mild adverse events (AEs) and Between-group (NR vs placebo) difference in change of clinical severity of PD, measured by UPDRS.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of NAD+ in 20 people with parkinson's disease.

Its size is small, so on its own it can only give an early look.

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.