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The Effect of NAD Supplementation on Brain Vascular Health in Aging

University of Oklahoma (OU) logo

University of Oklahoma (OU)

Status and phase

Enrolling
Phase 4

Conditions

Aging

Treatments

Drug: Nicotinamide riboside
Drug: Placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Full 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).

Enrollment

214 estimated patients

Sex

All

Ages

60 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

214 participants in 2 patient groups, including a placebo group

NR
Experimental group
Description:
Treatment with oral NR (1g/day per os for 8 weeks)
Treatment:
Drug: Nicotinamide riboside
Control
Placebo Comparator group
Description:
Visually identical placebo (daily, per os, for 8 weeks)
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Andriy Yabluchanskiy, MD, PhD

Data sourced from clinicaltrials.gov

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