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

This study is not yet open for participant recruitment.
Verified October 2017 by Becky Powers, The University of Texas Health Science Center at San Antonio
Sponsor:
ClinicalTrials.gov Identifier:
NCT02942888
First Posted: October 24, 2016
Last Update Posted: October 31, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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
  Purpose
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 Intervention
Mild Cognitive Impairment NAD Dietary Supplement: Nicotinamide riboside Dietary Supplement: Sugar Pill

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Becky Powers, The University of Texas Health Science Center at San Antonio:

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


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 26
Anticipated Study Start Date: December 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
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.

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.
  Contacts and Locations
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


Contacts
Contact: Becky Powers, M.D. 210 617-5197 PowersB3@uthscsa.edu; becky.powers@va.gov
Contact: Miranda E Orr, Ph.D. 210 275-8976 orrm3@uthscsa.edu

Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
University of Texas
South Texas Veterans Health Care System
Investigators
Principal Investigator: Becky Powers, M.D. University of Texas Health Science Center in San Antonio
  More Information

Responsible Party: Becky Powers, Assistant Professor, Medicine, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02942888     History of Changes
Other Study ID Numbers: HSC20160350H
First Submitted: August 29, 2016
First Posted: October 24, 2016
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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 Becky Powers, The University of Texas Health Science Center at San Antonio:
Mild Cognitive Impairment
MCI
NAD
nicotinamide riboside
aging

Additional relevant MeSH terms:
Niacinamide
Niacin
Nicotinic Acids
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents