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

The Effects of 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).

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment; NAD
• Intervention / Treatment: Dietary supplement: Nicotinamide riboside; Dietary supplement: Sugar Pill

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: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • South Texas Veterans Healthcare System (STVHCS)
    • San Antonio, Texas, United States, 78229
      • University of Texas Health San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Niagen; ChromaDex, Inc.; Dietary supplement: Sugar Pill; This is a placebo compounded by ChromaDex, Inc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cognitive Assessment - Montreal Cognitive Assessment (MoCA) - from baseline at 10 weeks	MoCA Value	10 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2017
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): August 16, 2021

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: October 20, 2016
• First Posted (Estimate): October 24, 2016

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment; MCI; aging; NAD; nicotinamide riboside
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Nicotinic Acids; Niacinamide; Niacin
• Other Study ID Numbers: HSC20160350H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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