Clinical trial NCT03816020: NAD-supplementation in Drug naïve Parkinson's Disease
Official title: NAD-PARK: A Double-blinded Randomized Pilot Trial of NAD-supplementation in Drug naïve Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Neurodegenerative Diseases
Keywords: clinical pilot, Nicotamide Riboside, Parkinson's Disease
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: PDRP changes from NR use
timeFrame: 4 weeks
Secondary outcomes:
measure: Motoric change of symptoms from NR use
timeFrame: 4 weeks
Other outcomes:
measure: Determine whether high dose oral NR rectifies NAD metabolism in body fluids and muscle tissue.
timeFrame: 4 weeks
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
state: Hordaland
Study officials:
affiliation: Nevro-Sysmed
name: Charalampos Tzoulis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brakedal B, Dolle C, Riemer F, Ma Y, Nido GS, Skeie GO, Craven AR, Schwarzlmuller T, Brekke N, Diab J, Sverkeli L, Skjeie V, Varhaug K, Tysnes OB, Peng S, Haugarvoll K, Ziegler M, Gruner R, Eidelberg D, Tzoulis C. The NADPARK study: A randomized phase I trial of nicotinamide riboside supplementation in Parkinson's disease. Cell Metab. 2022 Mar 1;34(3):396-407.e6. doi: 10.1016/j.cmet.2022.02.001.