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OpenTrials
Completed

NCT Number: NCT03816020

NAD-supplementation in Drug naïve Parkinson's Disease

1. Primary objective: Determine if NR has an impact on the neurometabolic profile of patients with PD as measured by [18F]Fluorodeoxyglucose (FDG)-positron emission tomography (FDG-PET). 2. Secondary objective: Determine whether high dose oral NR improves motor symptoms associated with PD. 3. Tertiary objectives: determine whether high dose oral NR rectifies NAD metabolism and increases NAD levels in body fluids and muscle tissue.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital

Bergen, Hordaland, 5021, Norway

About this study

Individuals with PD (n=30) will be recruited starting 14/02/2019 from the department of Neurology, Haukeland University Hospital. Only newly diagnosed and drug naïve PD patients are eligible for inclusion. After initial assessment at baseline, the participants will be randomly assigned (1:1) to one of two study groups (n = 15 per group): Nicotamide Riboside (NR) 500 mg x 2/day, or placebo. Participants and investigators will be masked to treatment group. Participants and investigators will be blinded (double blinded). The study will have a 4 week exposure period, during which patients will self-administer NR 500 mg x 2/day, or placebo per os. Patients will not be using any dopaminergic treatment during the study period. During baseline and 4 week follow-up, MDS-UPDRS will be performed as clinical measure. We will also collect blood, cerebral spinal fluid and muscle biopsy from all subjects at baseline and 4 week follow-up. Imaging will be performed using MRI, DAT Scan and FDG-PET at baseline and 4 week follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newly diagnosed with PD
  • Drug naïve with respect to dopaminergic treatment
  • Have a clinical diagnosis of idiopathic PD according to the MDS clinical diagnostic criteria for PD

Exclusion criteria

  • [¹²³I]FP-CIT single photon emission CT (DaTscan) does not show nigrostriatal degeneration.
  • Magnetic resonance imaging (MRI) suggestive of atypical parkinsonsism.
  • Dementia or other neurological disorder at baseline visit
  • Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit

Treatment and study plan

Nicotinamide riboside

Dietary Supplement

Nicotinamide Riboside capsules 250mg x 2 BID

Placebo

Other

Placebo capsules BID

Primary outcomes

  1. PDRP changes from NR use

    Time frame: 4 weeks

    The primary outcome will be the between-group difference in Parkinson's disease related pattern (PDRP) measured by FDG-PET comparing baseline and 3-4 week follow-up measurement.

Secondary outcomes

  1. Motoric change of symptoms from NR use

    Time frame: 4 weeks

    Clinical changes measured by MDS-UPDRS from using NR

Other outcomes

  1. Determine whether high dose oral NR rectifies NAD metabolism in body fluids and muscle tissue.

    Time frame: 4 weeks

    To measure NAD a liquid chromatography/tandem mass spectrometry will be use (abrv platform for method is LC-MS/MS.) We are interested in change of value of NAD. There is to our knowledge no measured NAD levels of PD patients. See PMID: 29184669 for the same method that we will use.

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

NAD-PARK: A Double-blinded Randomized Pilot Trial of NAD-supplementation in Drug naïve Parkinson's Disease

Acronym: NAD-PARK

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 25, 2019
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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