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

Study Overview
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Brief Summary
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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
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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).

Official Title
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The Effects of NAD on Brain Function and Cognition

Conditions
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Mild Cognitive Impairment, NAD

Intervention / Treatment
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* Dietary Supplement: Nicotinamide riboside
* Dietary Supplement: Sugar Pill


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy control<br>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<br>* Oral administration of Niagen ramp up 250mg to 1g/day as tolerated<br>* Other names: Niagen; ChromaDex, Inc.;Dietary Supplement: Sugar Pill<br>* This is a placebo compounded by ChromaDex, Inc.<br>|
| Experimental: MCI<br>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<br>* Oral administration of Niagen ramp up 250mg to 1g/day as tolerated<br>* Other names: Niagen; ChromaDex, Inc.;Dietary Supplement: Sugar Pill<br>* This is a placebo compounded by ChromaDex, Inc.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MCI, Mild Cognitive Impairment, NAD, nicotinamide riboside, aging