NAD-supplementation in Drug naïve Parkinson's Disease (NAD-PARK)
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|ClinicalTrials.gov Identifier: NCT03816020|
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : May 6, 2019
- 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).
- Secondary objective: Determine whether high dose oral NR improves motor symptoms associated with PD.
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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|
|Actual Study Start Date :||March 9, 2019|
|Estimated Primary Completion Date :||October 1, 2019|
|Estimated Study Completion Date :||October 1, 2019|
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
Placebo capsules BID
- 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.
- Motoric change of symptoms from NR use [ Time Frame: 4 weeks ]Clinical changes measured by MDS-UPDRS from using NR
- 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.
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
|Contact: Charalampos Tzoulis, PhD||55975045 ext +firstname.lastname@example.org|
|Contact: Brage Brakedal, MD||99777962 ext +email@example.com|
|Haukeland University Hospital||Recruiting|
|Bergen, Hordaland, Norway, 5021|
|Contact: Charalampos Tzoulis, PhD 55975045 ext +47 firstname.lastname@example.org|
|Contact: Brage Brakedal, MD 99777962 ext +47 email@example.com|