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

Primary Purpose

Mild Cognitive Impairment, NAD

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nicotinamide riboside
Sugar Pill
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, MCI, NAD, nicotinamide riboside, aging

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • South Texas Veterans Healthcare System (STVHCS)
  • University of Texas Health San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Healthy control

MCI

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in cerebral blood flow from baseline at 10 weeks
functional Magnetic Resonance Imaging (fMRI)
Change in plasma NAD from baseline at 10 weeks
Plasma NAD level
Change in Physical Performance - Short Physical Performance Battery (SPPB) - from baseline at 10 weeks
SPPB Score
Change in Physical Performance - Instrumental Activities of Daily Living (IADLs) - from baseline at 10 weeks
IADL Score
Change in endothelial function from baseline at 10 weeks
Arterial Pressure
Change in Cognitive Assessment - Geriatric Depression Scale (GDS) - from baseline at 10 weeks
GDS Value (>/= 5 is abnormal)
Change in Cognitive Assessment - Geriatric Anxiety Scale (GAS) - from baseline at 10 weeks
GAS Value (Raw score 1 -30)
Change in Cognitive Assessment - Clock Drawing Task Protocol (CLOX) - from baseline at 10 weeks
CLOX Value (Score 0-15)
Change in Cognitive Assessment - Executive Interview (EXIT) - from baseline at 10 weeks
EXIT Value (Score 0-50)
Change in Cognitive Assessment - Test of Auditory Processing Skills (TAPS) - from baseline at 10 weeks
TAPS Score
Change in Physical Performance - Grip Strength - from baseline at 10 weeks
Grip Strength (kgs)

Full Information

First Posted
August 29, 2016
Last Updated
August 31, 2021
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
University of Texas, South Texas Veterans Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT02942888
Brief Title
The Effects of Nicotinamide Adenine Dinucleotide (NAD) on Brain Function and Cognition
Acronym
NAD
Official Title
The Effects of NAD on Brain Function and Cognition
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
August 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
University of Texas, South Texas Veterans Health Care System

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, NAD
Keywords
Mild Cognitive Impairment, MCI, NAD, nicotinamide riboside, aging

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
MCI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nicotinamide riboside
Other Intervention Name(s)
Niagen; ChromaDex, Inc.
Intervention Description
Oral administration of Niagen ramp up 250mg to 1g/day as tolerated
Intervention Type
Dietary Supplement
Intervention Name(s)
Sugar Pill
Intervention Description
This is a placebo compounded by ChromaDex, Inc.
Primary Outcome Measure Information:
Title
Change in Cognitive Assessment - Montreal Cognitive Assessment (MoCA) - from baseline at 10 weeks
Description
MoCA Value
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Change in cerebral blood flow from baseline at 10 weeks
Description
functional Magnetic Resonance Imaging (fMRI)
Time Frame
10 weeks
Title
Change in plasma NAD from baseline at 10 weeks
Description
Plasma NAD level
Time Frame
10 weeks
Title
Change in Physical Performance - Short Physical Performance Battery (SPPB) - from baseline at 10 weeks
Description
SPPB Score
Time Frame
10 weeks
Title
Change in Physical Performance - Instrumental Activities of Daily Living (IADLs) - from baseline at 10 weeks
Description
IADL Score
Time Frame
10 weeks
Title
Change in endothelial function from baseline at 10 weeks
Description
Arterial Pressure
Time Frame
10 weeks
Title
Change in Cognitive Assessment - Geriatric Depression Scale (GDS) - from baseline at 10 weeks
Description
GDS Value (>/= 5 is abnormal)
Time Frame
10 weeks
Title
Change in Cognitive Assessment - Geriatric Anxiety Scale (GAS) - from baseline at 10 weeks
Description
GAS Value (Raw score 1 -30)
Time Frame
10 weeks
Title
Change in Cognitive Assessment - Clock Drawing Task Protocol (CLOX) - from baseline at 10 weeks
Description
CLOX Value (Score 0-15)
Time Frame
10 weeks
Title
Change in Cognitive Assessment - Executive Interview (EXIT) - from baseline at 10 weeks
Description
EXIT Value (Score 0-50)
Time Frame
10 weeks
Title
Change in Cognitive Assessment - Test of Auditory Processing Skills (TAPS) - from baseline at 10 weeks
Description
TAPS Score
Time Frame
10 weeks
Title
Change in Physical Performance - Grip Strength - from baseline at 10 weeks
Description
Grip Strength (kgs)
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Becky Powers, M.D.
Organizational Affiliation
University of Texas Health Science Center in San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Texas Veterans Healthcare System (STVHCS)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Texas Health San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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