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A Randomized Controlled Trial of Nicotinamide Riboside Supplementation in Early Parkinson's Disease

Plain-language guide to NCT03568968: phase 3 randomized trial of NAD+, parkinson's disease, 410 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03568968
Phase
phase 3
Status
completed
Start
2020-05-06
Completion (planned or actual)
2025-06-17
Participants
410 (actual)
Design
randomized, double-blind, treatment
Conditions studied
Parkinson Disease
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around NAD+ for parkinson's disease.

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

Placebo capsules, no active ingredients.

The registry classes the interventions as dietary supplement and other.

More on the Plan

Eligible participants must have been diagnosed with PD within 2 years of study enrollment and meet the trial's inclusion criteria.

The PD-treatment regimen will be frozen at baseline and remain stable throughout the duration of the study.

Both the participants and the investigators will be blinded.

The trial duration will be 52 weeks, during which participants will be assessed at baseline, 13, 26, 39 and 52 weeks.

Who Took Part

Enrollment: 410 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: Have a clinical diagnosis of idiopathic PD according to the MDS clinical diagnostic criteria for Parkinson's disease. \[¹²³I\]FP-CIT single photon emission CT (DaTscan) confirming nigrostriatal degeneration. Diagnosed with PD within 2 years from enrolment. Hoehn and Yahr score \< 3 at enrolment. Optimal symptomatic therapy, not requiring adjustments, for at least 1 month.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: dementia or other neurodegenerative disorder at baseline visit; diagnosed with atypical parkinsonism or vascular parkinsonism; any psychiatric disorder that would interfere with compliance in the study.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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

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

Blinding on both sides kept the parkinson's disease participants and researchers unaware of who received NAD+.

Those kept unaware of assignments: participant and investigator.

It started in 2020-05-06 with completion listed for 2025-06-17.

It ran at 11 sites in Norway (11).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Disease severity assessed by the total MDS-UPDRS (Movement Disorder Society Unified Parkinson's Disease rating Scale): sum of subsections I, II, and III (time frame: From baseline to the end of treatment at 52 weeks).

It also tracked 8 secondary outcomes, for example Severity of motor symptoms in PD, Severity of dopaminergic nigrostriatal denervation, assessed by [¹²³I]FP-CIT single photon emission CT (DaTscan), Severiy of non-motor symptoms in daily living in PD, Severity of motor aspects of experiences of daily living in PD, Severity of non-motor symptoms of PD assessed by the Non-Motor Symptoms Assessment Scale and Change in the clinical severity of cognitive decline assessed by the Montreal Cognitive Assessment (MoCA) scale.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of NAD+ in 410 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.

Our Notes on the Compound

NAD+: The coenzyme that accepts electrons at complex I.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.