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NAD-supplementation in Drug naïve Parkinson's Disease (NAD-PARK)

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ClinicalTrials.gov Identifier: NCT03816020
Recruitment Status : Not yet recruiting
First Posted : January 25, 2019
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

Brief Summary:
  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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Neurodegenerative Diseases Dietary Supplement: Nicotinamide Riboside Other: Placebo Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: After initial assessment at baseline, the participants will be randomly assigned (1:1) to one of two study groups (n = 15 per group): NR 500 mg x 2/day, or placebo. Participants and investigators will be masked to treatment group.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: All participants and investigators will be masked.
Primary Purpose: Basic Science
Official Title: NAD-PARK: A Double-blinded Randomized Pilot Trial of NAD-supplementation in Drug naïve Parkinson's Disease
Estimated Study Start Date : March 9, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: NR Group
Participants receiving Nicotinamide Riboside capsules, 500mg BI`D for 30 days
Dietary Supplement: Nicotinamide Riboside
Nicotinamide Riboside capsules 250mg x 2 BID

Placebo Comparator: Placebo Group
Participant receiving Placebo BIDfor 30 days
Other: Placebo
Placebo capsules BID




Primary Outcome Measures :
  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 Outcome Measures :
  1. Motoric change of symptoms from NR use [ Time Frame: 4 weeks ]
    Clinical changes measured by MDS-UPDRS from using NR


Other Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03816020


Contacts
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Contact: Charalampos Tzoulis, PhD 55975045 ext +47 charalampos.tzoulis@helse-bergen.no
Contact: Brage Brakedal, MD 99777962 ext +47 bragebrakedal@gmail.com

Locations
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Norway
Haukeland University Hospital Not yet recruiting
Bergen, Hordaland, Norway, 5021
Contact: Charalampos Tzoulis, PhD    55975045 ext +47    charalampos.tzoulis@helse-bergen.no   
Contact: Brage Brakedal, MD    99777962 ext +47    bragebrakedal@gmail.com   
Sponsors and Collaborators
Haukeland University Hospital

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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT03816020     History of Changes
Other Study ID Numbers: 2018/597
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haukeland University Hospital:
clinical pilot, Nicotamide Riboside, Parkinson's Disease

Additional relevant MeSH terms:
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Parkinson Disease
Neurodegenerative Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents