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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02942888
Recruitment Status : Completed
First Posted : October 24, 2016
Last Update Posted : September 2, 2021
Sponsor:
Collaborators:
University of Texas
South Texas Veterans Health Care System
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment NAD Dietary Supplement: Nicotinamide riboside Dietary Supplement: Sugar Pill Not Applicable

Detailed Description:

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: The Effects of NAD on Brain Function and Cognition
Actual Study Start Date : November 30, 2017
Actual Primary Completion Date : August 31, 2019
Actual Study Completion Date : August 16, 2021

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Healthy control
Oral administration of NAD precursor, nicotinamide riboside (Niagen; Chromadex Inc.) Dosing will consist of 250mg (week 1), 500mg (week 2), 750mg (week 3), 1g (weeks 4-10). Controls will receive sugar pills.
 Dietary Supplement: Nicotinamide riboside
Oral administration of Niagen ramp up 250mg to 1g/day as tolerated
Other Name: Niagen; ChromaDex, Inc.

Dietary Supplement: Sugar Pill
This is a placebo compounded by ChromaDex, Inc.
Experimental: MCI
Oral administration of NAD precursor, nicotinamide riboside (Niagen; Chromadex Inc.) Dosing will consist of 250mg (week 1), 500mg (week 2), 750mg (week 3), 1g (weeks 4-10).Controls will receive sugar pills.
 Dietary Supplement: Nicotinamide riboside
Oral administration of Niagen ramp up 250mg to 1g/day as tolerated
Other Name: Niagen; ChromaDex, Inc.

Dietary Supplement: Sugar Pill
This is a placebo compounded by ChromaDex, Inc.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Cognitive Assessment - Montreal Cognitive Assessment (MoCA) - from baseline at 10 weeks [ Time Frame: 10 weeks ]
    MoCA Value


Secondary Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02942888


Locations
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United States, Texas
South Texas Veterans Healthcare System (STVHCS)
San Antonio, Texas, United States, 78229
University of Texas Health San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
University of Texas
South Texas Veterans Health Care System
Investigators
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Principal Investigator: Becky Powers, M.D. University of Texas Health Science Center in San Antonio
More Information
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02942888    
Other Study ID Numbers: HSC20160350H
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: September 2, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by The University of Texas Health Science Center at San Antonio:
Mild Cognitive Impairment
MCI
NAD
nicotinamide riboside
aging
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
 Vitamins
Micronutrients
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents