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NAD Supplementation in Parkinson's Disease

8. juli 2026 opdateret af: University of Oklahoma

Neurovascular Coupling, Clinical Outcomes, and NAD Supplementation in Parkinson's Disease

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73117
        • Center for Geroscience and Healthy Brain Aging
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Active intervention
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.
Kosttilskud: Nicotinamide 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.
Placebo komparator: Placebo intervention
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.
Kosttilskud: Oral placebo capsules
1 g identically appearing placebo capsule

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in task-evoked neurovascular coupling response measured by functional near-infrared spectroscopy
Tidsramme: 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.
Baseline to 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in NIH Toolbox Cognitive Battery score
Tidsramme: 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.
Baseline to 12 weeks
Change in timed walking test completion
Tidsramme: 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.
Baseline to 12 weeks
Change in gait speed during single and dual-task walking
Tidsramme: 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.
Baseline to 12 weeks
Change in handgrip strength
Tidsramme: 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.
Baseline to 12 weeks
Change in static balance performance
Tidsramme: 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.
Baseline to 12 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in NAD⁺ concentrations and circulating NAD-related metabolites
Tidsramme: Baseline to 12 weeks
NAD⁺ concentrations and circulating NAD-related metabolites will be measured from blood samples collected at baseline and after 12 weeks of treatment. Changes from baseline to the 12-week follow-up visit will be compared between participants assigned to nicotinamide riboside and participants assigned to placebo.
Baseline to 12 weeks
Change in Montreal Cognitive Assessment score
Tidsramme: Baseline to 12 weeks
Global cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a brief screening tool used to evaluate memory and thinking problems. The reported outcome will be the change in total MoCA score (MoCA total score, range 0-30 points) from baseline to the 12-week follow-up visit and changes will be compared between participants assigned to nicotinamide riboside and participants assigned to placebo.
Baseline to 12 weeks
Change in Parkinson's motor rating scale score
Tidsramme: Baseline to 12 weeks
Motor function will be assessed using a standard Parkinson's disease motor rating scale. The reported outcome will be the change in total motor 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. Unit of Measure: Points on a scale
Baseline to 12 weeks
Change in body composition
Tidsramme: Baseline to 12 weeks
Body fat percentage will be measured using a body composition scale. The reported outcome (percent) will be the change in body fat percentage from baseline to the 12-week follow-up visit.
Baseline to 12 weeks
Change in skeletal muscle mass
Tidsramme: Baseline to 12 weeks
Skeletal muscle mass will be measured using a body composition scale. The reported outcome (kilograms) will be the change in skeletal muscle mass from baseline to the 12-week follow-up visit.
Baseline to 12 weeks
Change in sleep quality questionnaire score
Tidsramme: Baseline to 12 weeks

Sleep quality will be assessed using a standardized sleep quality questionnaire. The reported outcome will be the change in total sleep quality 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.

Unit of Measure: Points on a scale
Baseline to 12 weeks
Change in fatigue questionnaire score
Tidsramme: Baseline to 12 weeks

Fatigue will be assessed using a standardized fatigue questionnaire. The reported outcome will be the change in total fatigue score from baseline to the 12-week follow-up visit.

Unit of Measure: Points on a scale
Baseline to 12 weeks
Change in food security questionnaire score
Tidsramme: Baseline to 12 weeks
Food security will be assessed using a standardized food security questionnaire with a 30-day lookback period. The reported outcome will be the change in food security score from baseline to the 12-week follow-up visit. Unit of Measure: Points on a scale
Baseline to 12 weeks
Change in pain score
Tidsramme: Baseline to 12 weeks

Pain will be assessed using a standardized pain scale or questionnaire. The reported outcome will be the change in pain score from baseline to the 12-week follow-up visit.

Unit of Measure: Points on a scale
Baseline to 12 weeks
Change in daily step count measured by wrist-worn activity monitor watch
Tidsramme: Baseline to 12 weeks

Physical activity will be assessed using a wrist-worn activity monitor. The reported outcome will be the change in average daily step count from baseline to the 12-week follow-up period.

Unit of Measure: Steps per day
Baseline to 12 weeks
Change in total sleep time measured by wrist-worn activity monitor watch
Tidsramme: Baseline to 12 weeks

Sleep duration will be assessed using a wrist-worn activity monitor. The reported outcome will be the change in average total sleep time from baseline to the 12-week follow-up period.

Unit of Measure: Minutes per night
Baseline to 12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Oklahoma

Samarbejdspartnere

Presbyterian Health Foundation

Efterforskere

  • Ledende efterforsker: Andriy Yabluchanskiy, MD, PhD, University of Oklahoma Health Campus

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

26. juni 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 19742P

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Kliniske forsøg med Nicotinamide Riboside (NR)

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