Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

NAD Supplementation in Parkinson's Disease

8. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

40

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Spojené státy
    • Oklahoma
      • Oklahoma City, Oklahoma, Spojené státy, 73117
        • Center for Geroscience and Healthy Brain Aging
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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.
Doplněk stravy: 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.
Komparátor placeba: 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.
Doplněk stravy: Oral placebo capsules
1 g identically appearing placebo capsule

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in task-evoked neurovascular coupling response measured by functional near-infrared spectroscopy
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in NIH Toolbox Cognitive Battery score
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline in NAD⁺ concentrations and circulating NAD-related metabolites
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Oklahoma

Spolupracovníci

Presbyterian Health Foundation

Vyšetřovatelé

  • Vrchní vyšetřovatel: Andriy Yabluchanskiy, MD, PhD, University of Oklahoma Health Campus

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

1. června 2027

Dokončení studie (Odhadovaný)

1. června 2027

Termíny zápisu do studia

První předloženo

26. června 2026

První předloženo, které splnilo kritéria kontroly kvality

8. července 2026

První zveřejněno (Aktuální)

14. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

14. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 19742P

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Nicotinamide Riboside (NR)

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Georgia

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

3
Předplatit