NAD-supplementation in Drug naïve Parkinson's Disease

Parkinson Disease Clinical Trial

— NAD-PARK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03816020
• Other study ID #: 2018/597
• Status: Completed
• Phase: N/A
• Start date: March 9, 2019
• Est. completion date: February 10, 2020

Study information

• Verified date: February 2020
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 10, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurodegenerative Diseases
• Parkinson Disease

Intervention

Dietary Supplement:
• Nicotinamide Riboside
Nicotinamide Riboside capsules 250mg x 2 BID

Other:
• Placebo
Placebo capsules BID

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen	Hordaland

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Determine whether high dose oral NR rectifies NAD metabolism in body fluids and muscle tissue.	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.	4 weeks
Primary	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	Motoric change of symptoms from NR use	Clinical changes measured by MDS-UPDRS from using NR	4 weeks