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Recruiting NCT05483465

The Effect of NAD Supplementation on Brain Vascular Health in Aging

Phase IV Interventional Aging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nicotinamide riboside, Placebo.
Who it may be relevant to
Registry conditions: Aging. Basic parameters: 60 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects of NAD Restoration on Neurovascular Coupling in Community Dwelling Older Adults

Overview

Daily consumption of one of the forms of Vitamin B3, the Nicotinamide Riboside (NR), energizes the body and combats cellular aging. This study is designed to test whether NR can also improve brain health and memory.

Detailed description

This study is designed to test the hypothesis that restoration of Nicotinamide Adenine Dinucleotide (NAD) levels with Nicotinamide Riboside (NR) in older adults will improve neurovascular coupling (NVC) responses and micro- and macrovascular endothelial function. This hypothesis will be tested by assessing the effects of treatment with oral NR (1g/day per os for 8 weeks) or placebo (8 weeks) in community dwelling older adults (60-85 years of age).

Interventions

  • Drug Nicotinamide riboside
    Oral NR, 1g/day per os for 8 weeks
  • Drug Placebo
    Visually identical pill to NR, daily per os for 8 weeks

Primary outcome measures

  • Change in neurovascular coupling using functional near infrared spectroscopy (fNIRS) [Time frame: 8 weeks]
  • Change in neurovascular coupling using transcranial Doppler [Time frame: 8 weeks]
  • Change in neurovascular coupling using the dynamic retinal vessel analysis [Time frame: 8 weeks]
  • Change in neuronal activity [Time frame: 8 weeks]
Secondary outcome measures (12)
  • Change in microvascular endothelial function [Time frame: 8 weeks]
  • Change in macrovascular endothelial function [Time frame: 8 weeks]
  • Change in deep tissue oxygen saturation [Time frame: 8 weeks]
  • Change in arterial stiffness [Time frame: 8 weeks]
  • Change in ECG [Time frame: 8 weeks]
  • Change in Glycocalyx - perfused boundary region [Time frame: 8 weeks]
  • Change in capillary density [Time frame: 8 weeks]
  • Change in red blood cell velocity [Time frame: 8 weeks]
  • Change in Attention [Time frame: 8 weeks]
  • Change in Episodic Memory [Time frame: 8 weeks]
  • Change in Working Memory [Time frame: 8 weeks]
  • Change in Language [Time frame: 8 weeks]

Eligibility criteria

Inclusion criteria

  • Age ≥60 and ≤85 years of age
  • Adequate hearing and visual acuity to participate in the examinations
  • Ability to read and write in English
  • Competence to provide informed consent.
  • Mini-Mental State Exam score ≥24

Exclusion criteria

  • Vision or hearing impairment that would impair the ability to complete study assessments
  • Active CNS disease including multiple sclerosis, uncontrolled seizures, active brain 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 which, in the opinion of investigator, would render the patient inappropriate or too unstable to complete the study protocol

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

United States · 1 center
  • University of Oklahoma Health Sciences Center — Oklahoma City

Identifiers

NCT: NCT05483465 · 14782

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗