NAD Supplementation in Parkinson's Disease

NCT07703137 | Not Yet Recruiting

• 1 other identifier: 19742P
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether Nicotinamide Riboside, a form of Vitamin B3 also known as NR, can improve blood vessel health in the brain, memory, and physical function in eligible study participants. NR is considered investigational for this study because it is not yet established for this specific use. The main questions it aims to answer are: Can NR improve non-invasive measures of blood vessel health in the brain? Can NR improve memory testing results and physical function? Researchers will compare participants who receive NR with participants who receive a placebo, an inactive substance that looks like the study drug, to see if NR has beneficial effects. Participants will be randomly assigned to receive either NR or placebo. They will complete 3 study visits over 13 weeks at the Translational Geroscience Laboratory at the University of Oklahoma Health Campus. During the visits, participants will complete questionnaires, memory testing, non-invasive blood vessel measurements, physical function tests, and a blood draw.

Conditions

Parkinson's Disease

Keywords

nicotinamide riboside; Parkinson's disease; brain health; intervention

Outcome Measures

Primary Outcomes (1)

• Change in task-evoked neurovascular coupling response measured by functional near-infrared spectroscopy

  Neurovascular coupling will be assessed using functional near-infrared spectroscopy during study tasks. The primary reported value will be the change in task-evoked oxygenated hemoglobin response (change in oxygenated hemoglobin concentration in micromolar) from baseline to the 12-week follow-up visit. Changes will be compared between participants assigned to nicotinamide riboside and participants assigned to placebo.

  Baseline to 12 weeks

Secondary Outcomes (5)

• Change in NIH Toolbox Cognitive Battery score

  Baseline to 12 weeks

• Change in timed walking test completion

  Baseline to 12 weeks

• Change in gait speed during single and dual-task walking

  Baseline to 12 weeks

• Change in handgrip strength

  Baseline to 12 weeks

• Change in static balance performance

  Baseline to 12 weeks

Other Outcomes (11)

• Change from baseline in NAD⁺ concentrations and circulating NAD-related metabolites

  Baseline to 12 weeks

• Change in Montreal Cognitive Assessment score

  Baseline to 12 weeks

• Change in Parkinson's motor rating scale score

  Baseline to 12 weeks

Study Arms (2)

Active intervention

ACTIVE COMPARATOR

Participants will be randomized to receive either oral nicotinamide riboside at a total daily dose of 1 g or an identically appearing placebo for 12 weeks.

Dietary Supplement: Nicotinamide Riboside (NR)

Placebo intervention

PLACEBO COMPARATOR

Participants assigned to the placebo arm will take an oral placebo capsule daily for 12 weeks. The placebo will appear identical to the nicotinamide riboside capsules.

Dietary Supplement: Oral placebo capsules

Interventions

Nicotinamide Riboside (NR) DIETARY_SUPPLEMENT

Participants will be randomized to receive either oral nicotinamide riboside at a total daily dose of 1 g or an identically appearing placebo for 12 weeks.

Active intervention

Oral placebo capsules DIETARY_SUPPLEMENT

1 g identically appearing placebo capsule

Placebo intervention

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Parkinson's disease according to Movement Disorder Society clinical diagnostic criteria (59), Hoehn and Yahr stages I-III at enrollment (ON medication state when applicable) (60).
• Age ≥55 years at enrollment.
• Adequate hearing and visual acuity to participate in the examinations
• Ability to provide written informed consent in English.
• Ability to complete study procedures, including seated tasks and walking tasks (with or without an assistive device, if needed for safety).
• Stable antiparkinsonian medication regimen for ≥4 weeks prior to baseline (or drug-naive).

You may not qualify if:

• Not able to communicate or follow instructions due to aphasia or severe cognitive impairment.
• Active CNS disease including multiple sclerosis, uncontrolled seizures, active cancer.
• Cerebrovascular accident other than TIA within 60 days prior to Visit 0.
• Major psychiatric disease, including major depression not currently controlled on medications, alcohol or drug abuse.
• Abnormal kidney function (creatinine \>2mg/dL or EGFR \<30mL/min) by most recent labs within 6 months prior to Visit 0.
• Elevated liver enzymes (AST and/or ALT above x2 upper limit of normal) by most recent labs within 6 months prior to Visit 0.
• Treatment with other NAD enhancers (Nicotinamide riboside or nicotinamide mononucleotide) within 4 weeks prior to randomization.
• Any other medical condition and/or unstable or severe medical illness which, in the opinion of investigator, would render the patient inappropriate or too unstable to complete the study protocol.

Sponsors & Collaborators

• University of Oklahoma: lead
• Presbyterian Health Foundation: collaborator

Study Sites (1)

Center for Geroscience and Healthy Brain Aging

Oklahoma City, Oklahoma, 73117, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

nicotinamide-beta-riboside

Condition Hierarchy (Ancestors)

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

Study Officials

• Andriy Yabluchanskiy, MD, PhD

  University of Oklahoma Health Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zsuzsanna Tucsek-Cardon, PhD

CONTACT

572-271-9161; zsuzsanna-tucsekcardon@ou.edu

Zsofia Szarvas, MD, PhD

CONTACT

405-271-8130; zsofia-szarvas@ou.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to either the NR group or the placebo group, and they will remain in their assigned group throughout the study. The two groups will be compared to evaluate the effects of NR.

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 14, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)