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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

Tracking Information
First Submitted Date  ICMJE December 7, 2018
First Posted Date  ICMJE January 25, 2019
Last Update Posted Date February 25, 2019
Estimated Study Start Date  ICMJE March 9, 2019
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03816020 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2019)
Motoric change of symptoms from NR use [ Time Frame: 4 weeks ]
Clinical changes measured by MDS-UPDRS from using NR
Original Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2019)
Motoric improvement from NR use [ Time Frame: 4 weeks ]
Clinical changes measured by MDS-UPDRS from using NR
Current Other Outcome Measures  ICMJE
 (submitted: January 21, 2019)
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.
Original Other Outcome Measures  ICMJE Same as current
 
Descriptive Information
Brief Title  ICMJE NAD-supplementation in Drug naïve Parkinson's Disease
Official Title  ICMJE NAD-PARK: A Double-blinded Randomized Pilot Trial of NAD-supplementation in Drug naïve Parkinson's Disease
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.
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.
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Parkinson Disease
  • Neurodegenerative Diseases
Intervention  ICMJE
  • Dietary Supplement: Nicotinamide Riboside
    Nicotinamide Riboside capsules 250mg x 2 BID
  • Other: Placebo
    Placebo capsules BID
Study Arms
  • Active Comparator: NR Group
    Participants receiving Nicotinamide Riboside capsules, 500mg BI`D for 30 days
    Intervention: Dietary Supplement: Nicotinamide Riboside
  • Placebo Comparator: Placebo Group
    Participant receiving Placebo BIDfor 30 days
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 21, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date October 1, 2019
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: Charalampos Tzoulis, PhD 55975045 ext +47 charalampos.tzoulis@helse-bergen.no
Contact: Brage Brakedal, MD 99777962 ext +47 bragebrakedal@gmail.com
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03816020
Other Study ID Numbers  ICMJE 2018/597
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Haukeland University Hospital
Study Sponsor  ICMJE Haukeland University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Haukeland University Hospital
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP