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| Name | Class |
|---|---|
| University of Texas | OTHER |
| South Texas Veterans Health Care System | FED |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy control | Active Comparator | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotinamide riboside | Dietary Supplement | Oral administration of Niagen ramp up 250mg to 1g/day as tolerated |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cognitive Assessment - Montreal Cognitive Assessment (MoCA) - from baseline at 10 weeks | MoCA Value | 10 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Becky Powers, M.D. | University of Texas Health Science Center in San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Texas Veterans Healthcare System (STVHCS) | San Antonio | Texas | 78229 | United States | ||
| University of Texas Health San Antonio |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37994989 | Derived | Orr ME, Kotkowski E, Ramirez P, Bair-Kelps D, Liu Q, Brenner C, Schmidt MS, Fox PT, Larbi A, Tan C, Wong G, Gelfond J, Frost B, Espinoza S, Musi N, Powers B. A randomized placebo-controlled trial of nicotinamide riboside in older adults with mild cognitive impairment. Geroscience. 2024 Feb;46(1):665-682. doi: 10.1007/s11357-023-00999-9. Epub 2023 Nov 23. |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C018613 | nicotinamide-beta-riboside |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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| Sugar Pill | Dietary Supplement | This is a placebo compounded by ChromaDex, Inc. |
|
| 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 |
| San Antonio |
| Texas |
| 78229 |
| United States |