Parkinson's Disease
Conditions
Keywords
nicotinamide riboside, Parkinson's disease, brain health, intervention
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.
Detailed description
This is a single-site, randomized, placebo-controlled clinical trial evaluating oral nicotinamide riboside (NR), a form of vitamin B3, in adults over 55 years of age with Parkinson's disease. NR is commercially available as a dietary supplement, however, its use in this study for Parkinson's disease is considered investigational because it is not approved by the U.S. Food and Drug Administration as a treatment for Parkinson's disease. The purpose of this study is to explore whether daily NR supplementation over 12 weeks may improve measures related to brain health, memory, motor function, physical performance, and vascular function in participants with Parkinson's disease. Participants will be randomly assigned to receive either NR or placebo. Neither the participants nor the investigators will choose the assigned group. Study participation includes 3 in-person visits: screening, baseline, and follow-up. Study procedures include collection of medical and health information, questionnaires, blood draw, memory and cognitive testing, non-invasive measurements of brain activity and blood vessel function, walking and balance assessments, grip strength testing, and use of a study watch to assess activity and sleep patterns. The study procedures will be conducted at the Translational Geroscience Laboratory at the University of Oklahoma Health Sciences Center.
Interventions
DIETARY_SUPPLEMENTNicotinamide Riboside (NR)
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_SUPPLEMENTOral placebo capsules
1 g identically appearing placebo capsule
Sponsors
University of Oklahoma
Presbyterian Health Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in task-evoked neurovascular coupling response measured by functional near-infrared spectroscopy | Baseline to 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in NIH Toolbox Cognitive Battery score | Baseline to 12 weeks | Cognitive performance will be assessed using the NIH Toolbox Cognitive Battery, a computer-based set of tests designed to measure cognitive domains such as memory, attention, executive function, and processing speed. The reported outcome will be the change in NIH Toolbox Cognitive Battery score from baseline to the 12-week follow-up visit. Changes will be compared between participants assigned to nicotinamide riboside and participants assigned to placebo. |
| Change in timed walking test completion | Baseline to 12 weeks | Walking performance will be assessed using a timed walking test. The reported outcome will be the change in time (seconds) required to complete the walking test from baseline to the 12-week follow-up visit. |
| Change in gait speed during single and dual-task walking | Baseline to 12 weeks | Gait speed will be measured using a pressure-sensing walkway during normal walking and while participants walk and perform a cognitive task, such as serial subtraction. The reported outcome will be the change in gait speed (meter/second) from baseline to the 12-week follow-up visit. |
| Change in handgrip strength | Baseline to 12 weeks | Handgrip strength will be measured using a hand-grip dynamometer. Three trials will be performed for each hand, and the reported value (kilograms-force) will be the average grip strength. The reported outcome will be the change in average handgrip strength from baseline to the 12-week follow-up visit. |
| Change in static balance performance | Baseline to 12 weeks | Static balance will be assessed while participants stand with eyes open and eyes closed on both a firm surface and a foam surface. The reported outcome will be the change in the selected balance parameter (seconds, sway area and center-of-pressure displacement) from baseline to the 12-week follow-up visit. |
Countries
United States
Contacts
CONTACTZsuzsanna Tucsek-Cardon, PhD
CONTACTZsofia Szarvas, MD, PhD
PRINCIPAL_INVESTIGATORAndriy Yabluchanskiy, MD, PhD
University of Oklahoma Health Campus
Outcome results
None listed