Mild Cognitive Impairment, NAD
Conditions
Keywords
Mild Cognitive Impairment, MCI, NAD, nicotinamide riboside, aging
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).
Interventions
DIETARY_SUPPLEMENTNicotinamide riboside
Oral administration of Niagen ramp up 250mg to 1g/day as tolerated
DIETARY_SUPPLEMENTSugar Pill
This is a placebo compounded by ChromaDex, Inc.
Sponsors
University of Texas
South Texas Veterans Health Care System
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive Assessment - Montreal Cognitive Assessment (MoCA) - from baseline at 10 weeks | 10 weeks | MoCA Value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in plasma NAD from baseline at 10 weeks | 10 weeks | Plasma NAD level |
| Change in Physical Performance - Short Physical Performance Battery (SPPB) - from baseline at 10 weeks | 10 weeks | SPPB Score |
| Change in Physical Performance - Instrumental Activities of Daily Living (IADLs) - from baseline at 10 weeks | 10 weeks | IADL Score |
| Change in endothelial function from baseline at 10 weeks | 10 weeks | Arterial Pressure |
| Change in Cognitive Assessment - Geriatric Depression Scale (GDS) - from baseline at 10 weeks | 10 weeks | GDS Value (\>/= 5 is abnormal) |
| Change in cerebral blood flow from baseline at 10 weeks | 10 weeks | functional Magnetic Resonance Imaging (fMRI) |
| 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 Cognitive Assessment - Test of Auditory Processing Skills (TAPS) - from baseline at 10 weeks | 10 weeks | TAPS Score |
| Change in Physical Performance - Grip Strength - from baseline at 10 weeks | 10 weeks | Grip Strength (kgs) |
| Change in Cognitive Assessment - Geriatric Anxiety Scale (GAS) - from baseline at 10 weeks | 10 weeks | GAS Value (Raw score 1 -30) |
Countries
United States
Outcome results
None listed