Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

NAD Supplementation in Parkinson's Disease

8 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73117
        • Center for Geroscience and Healthy Brain Aging
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Integratore alimentare: 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.
Comparatore placebo: 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.
Integratore alimentare: Oral placebo capsules
1 g identically appearing placebo capsule

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in task-evoked neurovascular coupling response measured by functional near-infrared spectroscopy
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in NIH Toolbox Cognitive Battery score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline in NAD⁺ concentrations and circulating NAD-related metabolites
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Oklahoma

Collaboratori

Presbyterian Health Foundation

Investigatori

  • Investigatore principale: Andriy Yabluchanskiy, MD, PhD, University of Oklahoma Health Campus

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 giugno 2027

Completamento dello studio (Stimato)

1 giugno 2027

Date di iscrizione allo studio

Primo inviato

26 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 luglio 2026

Primo Inserito (Effettivo)

14 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 19742P

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Nicotinamide Riboside (NR)

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Peru

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi