[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07703137":3,"trial-entities:NCT07703137":107,"trial-summary:NCT07703137":111},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":44,"secondary_outcomes":49,"sex":65,"minimum_age":66,"maximum_age":67,"healthy_volunteers":15,"eligibility_criteria":68,"std_ages":86,"locations":89,"central_contacts":99,"overall_officials":100,"references":105,"see_also_links":106},"NCT07703137","19742P","NAD Supplementation in Parkinson's Disease","Neurovascular Coupling, Clinical Outcomes, and NAD Supplementation in Parkinson's Disease","ENROLLING_BY_INVITATION","2027-07","2026-08","2026-08-12","2026-08-10","University of Oklahoma","OTHER",false,"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.\n\nThe main questions it aims to answer are:\n\nCan NR improve non-invasive measures of blood vessel health in the brain? Can NR improve memory testing results and physical function?\n\nResearchers 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.\n\nThey 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.","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.\n\nThe 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.\n\nStudy 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.\n\nThe study procedures will be conducted at the Translational Geroscience Laboratory at the University of Oklahoma Health Sciences Center.",[19],"Parkinson's Disease",[21,22,23,24],"nicotinamide riboside","Parkinson's disease","brain health","intervention","INTERVENTIONAL","PREVENTION",[28],"NA",{"count":30,"type":31},40,"ESTIMATED",[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DIETARY_SUPPLEMENT","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.",[38],"Active intervention",{"type":34,"name":40,"description":41,"armGroupLabels":42},"Oral placebo capsules","1 g identically appearing placebo capsule",[43],"Placebo intervention",[45],{"measure":46,"description":47,"timeFrame":48},"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",[50,53,56,59,62],{"measure":51,"description":52,"timeFrame":48},"Change in NIH Toolbox Cognitive Battery score","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.",{"measure":54,"description":55,"timeFrame":48},"Change in timed walking test completion","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.",{"measure":57,"description":58,"timeFrame":48},"Change in gait speed during single and dual-task walking","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\u002Fsecond) from baseline to the 12-week follow-up visit.",{"measure":60,"description":61,"timeFrame":48},"Change in handgrip strength","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.",{"measure":63,"description":64,"timeFrame":48},"Change in static balance performance","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.","ALL","55 Years","85 Years",{"inclusion":69,"exclusion":76,"raw_text":85},[70,71,72,73,74,75],"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).",[77,78,79,80,81,82,83,84],"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\u002FdL or EGFR \\\u003C30mL\u002Fmin) by most recent labs within 6 months prior to Visit 0.","Elevated liver enzymes (AST and\u002For 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\u002For unstable or severe medical illness which, in the opinion of investigator, would render the patient inappropriate or too unstable to complete the study protocol.","Inclusion Criteria:\n\n* 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).\n* Age ≥55 years at enrollment.\n* Adequate hearing and visual acuity to participate in the examinations\n* Ability to provide written informed consent in English.\n* Ability to complete study procedures, including seated tasks and walking tasks (with or without an assistive device, if needed for safety).\n* Stable antiparkinsonian medication regimen for ≥4 weeks prior to baseline (or drug-naive).\n\nExclusion Criteria:\n\n* Not able to communicate or follow instructions due to aphasia or severe cognitive impairment.\n* Active CNS disease including multiple sclerosis, uncontrolled seizures, active cancer.\n* Cerebrovascular accident other than TIA within 60 days prior to Visit 0.\n* Major psychiatric disease, including major depression not currently controlled on medications, alcohol or drug abuse.\n* Abnormal kidney function (creatinine \\>2mg\u002FdL or EGFR \\\u003C30mL\u002Fmin) by most recent labs within 6 months prior to Visit 0.\n* Elevated liver enzymes (AST and\u002For ALT above x2 upper limit of normal) by most recent labs within 6 months prior to Visit 0.\n* Treatment with other NAD enhancers (Nicotinamide riboside or nicotinamide mononucleotide) within 4 weeks prior to randomization.\n* Any other medical condition and\u002For unstable or severe medical illness which, in the opinion of investigator, would render the patient inappropriate or too unstable to complete the study protocol.",[87,88],"ADULT","OLDER_ADULT",[90],{"facility":91,"city":92,"state":93,"zip":94,"country":95,"geoPoint":96},"Center for Geroscience and Healthy Brain Aging","Oklahoma City","Oklahoma","73117","United States",{"lat":97,"lon":98},35.46756,-97.51643,[],[101],{"name":102,"affiliation":103,"role":104},"Andriy Yabluchanskiy, MD, PhD","University of Oklahoma Health Campus","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":108,"biomarkers":110},[109],"Parkinson Disease",[],{"nct_id":4,"found":112,"summary":113,"prompt_version":122},true,{"design":114,"status":115,"heading":6,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is a randomized, placebo-controlled study with 40 participants. It compares Nicotinamide Riboside to a placebo.","completed","This study is looking into whether Nicotinamide Riboside (NR), a form of Vitamin B3, can help people with Parkinson's disease. Researchers want to see if NR can improve blood vessel health in the brain, memory, and physical abilities. You might be able to join if you are 55 to 85 years old and have been diagnosed with Parkinson's disease (Hoehn and Yahr stages I-III). The study will compare participants who receive NR to those who receive a placebo (an inactive substance that looks like NR). Success would mean that NR improves measures of brain blood vessel health, memory test results, and physical function. The current recruitment status is unclear.","Participants will be followed for 12 weeks after starting the intervention.",109,"You would have 3 in-person visits over 12 weeks, including screening, a baseline visit, and a follow-up visit. Procedures include questionnaires, blood draws, memory and cognitive tests, brain activity measurements, walking and balance tests, grip strength, and wearing a study watch.","Not stated in the trial record.",[35],"v2"]