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The Effects of Nicotinamide Adenine Dinucleotide (NAD) on Brain Function and Cognition
Plain-language guide to NCT02942888: not phased randomized trial of NAD+, 46 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02942888
- Phase
- not phased
- Status
- completed
- Start
- 2017-11-30
- Completion (planned or actual)
- 2019-08-31
- Participants
- 46 (actual)
- Design
- randomized, triple-blind, basic_science
- Conditions studied
- Mild Cognitive Impairment; NAD
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around NAD+.
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).
It had two arms (groups): one (active comparator) and MCI (experimental).
The registry classes the interventions as dietary supplement.
More on the Plan
Niagen is a patented formula which is the first and only commercially available form of Nicotinamide Riboside (NR).
NAD helps pass energy from glucose to other pathways in the cell.
Who Took Part
Enrollment: 46 actual participants took part.
It was open to people of any sex aged from 65 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: 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.
How the Study Was Run
Design: randomized, factorial and triple-blind.
The participants were allocated by chance, so the NAD+ group and the comparison group should start out alike.
Neither the participants nor the staff measuring them knew who was on NAD+, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, care provider and investigator.
It started in 2017-11-30 with completion listed for 2019-08-31.
It ran at 2 sites in United States (2).
Its stated primary purpose is basic science.
What Was Measured
Researchers chose this as the main measure: Change in Cognitive Assessment - Montreal Cognitive Assessment (MoCA) - from baseline at 10 weeks (time frame: 10 weeks).
It also tracked 11 secondary outcomes, for example Change in cerebral blood flow from baseline at 10 weeks, Change in plasma NAD from baseline at 10 weeks, Change in Physical Performance - Short Physical Performance Battery (SPPB) - from baseline at 10 weeks, Change in Physical Performance - Instrumental Activities of Daily Living (IADLs) - from baseline at 10 weeks, Change in endothelial function from baseline at 10 weeks and Change in Cognitive Assessment - Geriatric Depression Scale (GDS) - from baseline at 10 weeks.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of NAD+ in 46 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the NAD+ compound page, all human trials.
Our Notes on the Compound
NAD+: The coenzyme that accepts electrons at complex I.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.