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

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment; NAD
• Interventions: Dietary Supplement: Nicotinamide riboside; Dietary Supplement: Sugar Pill

• Registration Number: NCT02942888
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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 Timeline

• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-10-20
• Study First Posted: 2016-10-24
• Study Start: 2017-11-30
• Primary Completion: 2019-08-31
• Status Verified: 2021-08
• Study Completion: 2021-08-16
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Healthy control	Sugar Pill	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.
Healthy control	Nicotinamide riboside	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.
MCI	Nicotinamide riboside	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.
MCI	Sugar Pill	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University of Texas Health San Antonio; 🇺🇸 San Antonio, Texas, United States

South Texas Veterans Healthcare System (STVHCS); 🇺🇸 San Antonio, Texas, United States