NAD-supplementation in Drug naïve Parkinson's Disease

NCT03816020 | Completed DMC

• 1 other identifier: 2018/597
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Secondary objective: Determine whether high dose oral NR improves motor symptoms associated with PD.
3. 3.Tertiary objectives: determine whether high dose oral NR rectifies NAD metabolism and increases NAD levels in body fluids and muscle tissue.

Conditions

Parkinson Disease; Neurodegenerative Diseases

Keywords

clinical pilot, Nicotamide Riboside, Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Motoric change of symptoms from NR use

  4 weeks

Other Outcomes (1)

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

  4 weeks

Study Arms (2)

NR Group

ACTIVE COMPARATOR

Participants receiving Nicotinamide Riboside capsules, 500mg BI'D for 30 days

Dietary Supplement: Nicotinamide Riboside

Placebo Group

PLACEBO COMPARATOR

Participant receiving Placebo BIDfor 30 days

Other: Placebo

Interventions

Nicotinamide Riboside DIETARY_SUPPLEMENT

Nicotinamide Riboside capsules 250mg x 2 BID

NR Group

Placebo OTHER

Placebo capsules BID

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \[¹²³I\]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

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, Hordaland, 5021, Norway

Location

Related Publications (1)

• 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.

  PMID: 35235774 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Neurodegenerative Diseases

Interventions

nicotinamide-beta-riboside

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies

Study Officials

• Charalampos Tzoulis, PhD

  Nevro-Sysmed

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All participants and investigators will be masked.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: January 25, 2019
• Study Start: March 9, 2019
• Primary Completion: February 10, 2020
• Study Completion: February 10, 2020
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)