NAD-PARK: NAD-supplementation in Drug naïve Parkinson's Disease

Sponsor

Haukeland University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03816020

Collaborator

(none)

Enrollment

Location

Arms

11.1

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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	N/A

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 Design

Study Type:

Interventional

Actual 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.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 :

Mar 9, 2019

Actual Primary Completion Date :

Feb 10, 2020

Actual Study Completion Date :

Feb 10, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

PDRP changes from NR use [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

Motoric change of symptoms from NR use [4 weeks]
Clinical changes measured by MDS-UPDRS from using NR

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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