NAD-supplementation in Drug naïve Parkinson's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Parkinson Disease, Neurodegenerative Diseases

Intervention / Treatment
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* Dietary Supplement: Nicotinamide Riboside
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NR Group<br>Participants receiving Nicotinamide Riboside capsules, 500mg BI'D for 30 days | Dietary Supplement: Nicotinamide Riboside<br>* Nicotinamide Riboside capsules 250mg x 2 BID<br>|
| Placebo Comparator: Placebo Group<br>Participant receiving Placebo BIDfor 30 days | Other: Placebo<br>* Placebo capsules BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PDRP changes from NR use | 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motoric change of symptoms from NR use | Clinical changes measured by MDS-UPDRS from using NR | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical pilot, Nicotamide Riboside, Parkinson's Disease