Neurodegenerative Diseases, Parkinson Disease
Conditions
Keywords
clinical pilot, Nicotamide Riboside, 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.
Interventions
DIETARY_SUPPLEMENTNicotinamide Riboside
Nicotinamide Riboside capsules 250mg x 2 BID
OTHERPlacebo
Placebo capsules BID
Sponsors
Haukeland University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
All participants and investigators will be masked.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Motoric change of symptoms from NR use | 4 weeks | Clinical changes measured by MDS-UPDRS from using NR |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Norway
Outcome results
None listed