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Completed

NCT Number: NCT02942888

The Effects of Nicotinamide Adenine Dinucleotide (NAD) on Brain Function and Cognition

The purpose of this study is to determine the effects of Niagen (nicotinamide riboside, vitamin B3), on NAD levels, brain function including cognition and blood flow in people diagnosed with mild cognitive impairment (MCI).

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders NAD Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Texas Veterans Healthcare System (STVHCS), San Antonio, Texas, United States

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About this study

Niagen is a patented formula which is the first and only commercially available form of Nicotinamide Riboside (NR). It has been proven in basic science studies as a highly effective NAD booster, but it also works as a vitamin B3 supplement. NAD helps pass energy from glucose to other pathways in the cell. Niagen (Nicotinamide Riboside, vitamin B3) is one of the most effective NAD+ precursors to support cellular health.

The purpose of this study is to determine the effects of Niagen (nicotinamide riboside, vitamin B3), on NAD levels, brain function including cognition and blood flow in people diagnosed with mild cognitive impairment (MCI).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previously diagnosed with MCI based on inclusion criteria of Texas Alzheimer's Research Care and Consortium (TARCC) study (IRB: HSC20090535H). We are enrolling both genders, all races and ethnic groups.
  • Two week washout period for participants who were taking opioids or a dose of niacin over 200mg

Exclusion criteria

  • Previously considered as healthy individuals without a MCI or Alzheimer's disease diagnosis based on exclusion criteria of the TARCC study (IRB: HSC20090535H).
  • Neurological, psychiatric or active systemic medical disease
  • Diabetes
  • Moderate or severe depression and/or anxiety as determined the Geriatric Depression Scale (GDS) and the Geriatric Anxiety Scale (GAS), respectively
  • Diagnosis of dementia
  • Hearing, vision, motor or language deficits
  • Alcohol or drug abuse
  • Implantation of metal devices
  • Administration of Alzheimer's drugs, anticholinergics, neuroleptics, anticonvulsants, opiates, systemic steroids, and mood-stabilizers.
  • No opioid use while participating in study

Treatment and study plan

Nicotinamide riboside

Dietary Supplement

Oral administration of Niagen ramp up 250mg to 1g/day as tolerated

Other names: Niagen; ChromaDex, Inc.

Sugar Pill

Dietary Supplement

This is a placebo compounded by ChromaDex, Inc.

Primary outcomes

  1. Change in Cognitive Assessment - Montreal Cognitive Assessment (MoCA) - from baseline at 10 weeks

    Time frame: 10 weeks

    MoCA Value

Secondary outcomes

  1. Change in cerebral blood flow from baseline at 10 weeks

    Time frame: 10 weeks

    functional Magnetic Resonance Imaging (fMRI)

  2. Change in plasma NAD from baseline at 10 weeks

    Time frame: 10 weeks

    Plasma NAD level

  3. Change in Physical Performance - Short Physical Performance Battery (SPPB) - from baseline at 10 weeks

    Time frame: 10 weeks

    SPPB Score

  4. Change in Physical Performance - Instrumental Activities of Daily Living (IADLs) - from baseline at 10 weeks

    Time frame: 10 weeks

    IADL Score

  5. Change in endothelial function from baseline at 10 weeks

    Time frame: 10 weeks

    Arterial Pressure

  6. Change in Cognitive Assessment - Geriatric Depression Scale (GDS) - from baseline at 10 weeks

    Time frame: 10 weeks

    GDS Value (>/= 5 is abnormal)

  7. Change in Cognitive Assessment - Geriatric Anxiety Scale (GAS) - from baseline at 10 weeks

    Time frame: 10 weeks

    GAS Value (Raw score 1 -30)

  8. Change in Cognitive Assessment - Clock Drawing Task Protocol (CLOX) - from baseline at 10 weeks

    Time frame: 10 weeks

    CLOX Value (Score 0-15)

  9. Change in Cognitive Assessment - Executive Interview (EXIT) - from baseline at 10 weeks

    Time frame: 10 weeks

    EXIT Value (Score 0-50)

  10. Change in Cognitive Assessment - Test of Auditory Processing Skills (TAPS) - from baseline at 10 weeks

    Time frame: 10 weeks

    TAPS Score

  11. Change in Physical Performance - Grip Strength - from baseline at 10 weeks

    Time frame: 10 weeks

    Grip Strength (kgs)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • South Texas Veterans Health Care System
  • University of Texas

Registry information

Official study title

The Effects of NAD on Brain Function and Cognition

Acronym: NAD

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Oct 24, 2016
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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