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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 : Active, not recruiting
First Posted : October 24, 2016
Last Update Posted : September 5, 2019
Sponsor:
Collaborators:
University of Texas
South Texas Veterans Health Care System
Information provided by (Responsible Party):
Becky Powers, The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date  ICMJE August 29, 2016
First Posted Date  ICMJE October 24, 2016
Last Update Posted Date September 5, 2019
Actual Study Start Date  ICMJE November 30, 2017
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2016)
Change in Cognitive Assessment - Montreal Cognitive Assessment (MoCA) - from baseline at 10 weeks [ Time Frame: 10 weeks ]
MoCA Value
Original Primary Outcome Measures  ICMJE
 (submitted: October 20, 2016)
  • Change in Cognitive Assessment - Montreal Cognitive Assessment (MoCA) - from baseline at 10 weeks [ Time Frame: Baseline ]
    MoCA Value
  • Change in Cognitive Assessment - Montreal Cognitive Assessment (MoCA) - from baseline at 10 weeks [ Time Frame: 10 weeks ]
    MoCA Value
Change History Complete list of historical versions of study NCT02942888 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2016)
  • Change in cerebral blood flow from baseline at 10 weeks [ Time Frame: 10 weeks ]
    functional Magnetic Resonance Imaging (fMRI)
  • Change in plasma NAD from baseline at 10 weeks [ Time Frame: 10 weeks ]
    Plasma NAD level
  • Change in Physical Performance - Short Physical Performance Battery (SPPB) - from baseline at 10 weeks [ Time Frame: 10 weeks ]
    SPPB Score
  • Change in Physical Performance - Instrumental Activities of Daily Living (IADLs) - from baseline at 10 weeks [ Time Frame: 10 weeks ]
    IADL Score
  • Change in endothelial function from baseline at 10 weeks [ Time Frame: 10 weeks ]
    Arterial Pressure
  • Change in Cognitive Assessment - Geriatric Depression Scale (GDS) - from baseline at 10 weeks [ Time Frame: 10 weeks ]
    GDS Value (>/= 5 is abnormal)
  • Change in Cognitive Assessment - Geriatric Anxiety Scale (GAS) - from baseline at 10 weeks [ Time Frame: 10 weeks ]
    GAS Value (Raw score 1 -30)
  • Change in Cognitive Assessment - Clock Drawing Task Protocol (CLOX) - from baseline at 10 weeks [ Time Frame: 10 weeks ]
    CLOX Value (Score 0-15)
  • Change in Cognitive Assessment - Executive Interview (EXIT) - from baseline at 10 weeks [ Time Frame: 10 weeks ]
    EXIT Value (Score 0-50)
  • Change in Cognitive Assessment - Test of Auditory Processing Skills (TAPS) - from baseline at 10 weeks [ Time Frame: 10 weeks ]
    TAPS Score
  • Change in Physical Performance - Grip Strength - from baseline at 10 weeks [ Time Frame: 10 weeks ]
    Grip Strength (kgs)
Original Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2016)
  • Change in cerebral blood flow from baseline at 10 weeks [ Time Frame: Baseline ]
    functional Magnetic Resonance Imaging (fMRI)
  • Change in cerebral blood flow from baseline at 10 weeks [ Time Frame: 10 weeks ]
    functional Magnetic Resonance Imaging (fMRI)
  • Change in plasma NAD from baseline at 10 weeks [ Time Frame: Baseline ]
    Plasma NAD level
  • Change in plasma NAD from baseline at 10 weeks [ Time Frame: 10 weeks ]
    Plasma NAD level
  • Change in Physical Performance - Short Physical Performance Battery (SPPB) - from baseline at 10 weeks [ Time Frame: Baseline ]
    SPPB Score
  • Change in Physical Performance - Short Physical Performance Battery (SPPB) - from baseline at 10 weeks [ Time Frame: 10 weeks ]
    SPPB Score
  • Change in Physical Performance - Instrumental Activities of Daily Living (IADLs) - from baseline at 10 weeks [ Time Frame: Baseline ]
    IADL Score
  • Change in Physical Performance - Instrumental Activities of Daily Living (IADLs) - from baseline at 10 weeks [ Time Frame: 10 weeks ]
    IADL Score
  • Change in endothelial function from baseline at 10 weeks [ Time Frame: Baseline ]
    Arterial Pressure
  • Change in endothelial function from baseline at 10 weeks [ Time Frame: 10 weeks ]
    Arterial Pressure
  • Change in Cognitive Assessment - Geriatric Depression Scale (GDS) - from baseline at 10 weeks [ Time Frame: Baseline ]
    GDS Value (>/= 5 is abnormal)
  • Change in Cognitive Assessment - Geriatric Depression Scale (GDS) - from baseline at 10 weeks [ Time Frame: 10 weeks ]
    GDS Value (>/= 5 is abnormal)
  • Change in Cognitive Assessment - Geriatric Anxiety Scale (GAS) - from baseline at 10 weeks [ Time Frame: Baseline ]
    GAS Value (Raw score 1 -30)
  • Change in Cognitive Assessment - Geriatric Anxiety Scale (GAS) - from baseline at 10 weeks [ Time Frame: 10 weeks ]
    GAS Value (Raw score 1 -30)
  • Change in Cognitive Assessment - Clock Drawing Task Protocol (CLOX) - from baseline at 10 weeks [ Time Frame: Baseline ]
    CLOX Value (Score 0-15)
  • Change in Cognitive Assessment - Clock Drawing Task Protocol (CLOX) - from baseline at 10 weeks [ Time Frame: 10 weeks ]
    CLOX Value (Score 0-15)
  • Change in Cognitive Assessment - Executive Interview (EXIT) - from baseline at 10 weeks [ Time Frame: Baseline ]
    EXIT Value (Score 0-50)
  • Change in Cognitive Assessment - Executive Interview (EXIT) - from baseline at 10 weeks [ Time Frame: 10 weeks ]
    EXIT Value (Score 0-50)
  • Change in Cognitive Assessment - Test of Auditory Processing Skills (TAPS) - from baseline at 10 weeks [ Time Frame: Baseline ]
    TAPS Score
  • Change in Cognitive Assessment - Test of Auditory Processing Skills (TAPS) - from baseline at 10 weeks [ Time Frame: 10 weeks ]
    TAPS Score
  • Change in Physical Performance - Grip Strength - from baseline at 10 weeks [ Time Frame: Baseline ]
    Grip Strength (kgs)
  • Change in Physical Performance - Grip Strength - from baseline at 10 weeks [ Time Frame: 10 weeks ]
    Grip Strength (kgs)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Nicotinamide Adenine Dinucleotide (NAD) on Brain Function and Cognition
Official Title  ICMJE The Effects of NAD on Brain Function and Cognition
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Mild Cognitive Impairment
  • NAD
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Dietary Supplement: Nicotinamide riboside
    • Dietary Supplement: Sugar Pill
  • 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.
    Interventions:
    • Dietary Supplement: Nicotinamide riboside
    • Dietary Supplement: Sugar Pill
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 3, 2019)
46
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2016)
26
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02942888
Other Study ID Numbers  ICMJE HSC20160350H
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Becky Powers, The University of Texas Health Science Center at San Antonio
Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Collaborators  ICMJE
  • University of Texas
  • South Texas Veterans Health Care System
Investigators  ICMJE
Principal Investigator: Becky Powers, M.D. University of Texas Health Science Center in San Antonio
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP