The Effects of Nicotinamide Adenine Dinucleotide (NAD) on Brain Function and Cognition (NAD)
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ClinicalTrials.gov Identifier: NCT02942888 |
Recruitment Status :
Completed
First Posted : October 24, 2016
Last Update Posted : September 2, 2021
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Tracking Information | |||||||
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First Submitted Date ICMJE | August 29, 2016 | ||||||
First Posted Date ICMJE | October 24, 2016 | ||||||
Last Update Posted Date | September 2, 2021 | ||||||
Actual Study Start Date ICMJE | November 30, 2017 | ||||||
Actual Primary Completion Date | August 31, 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Change in Cognitive Assessment - Montreal Cognitive Assessment (MoCA) - from baseline at 10 weeks [ Time Frame: 10 weeks ] MoCA Value
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | The Effects of Nicotinamide Adenine Dinucleotide (NAD) on Brain Function and Cognition | ||||||
Official Title ICMJE | The Effects of NAD on Brain Function and Cognition | ||||||
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). |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Basic Science |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
46 | ||||||
Original Estimated Enrollment ICMJE |
26 | ||||||
Actual Study Completion Date ICMJE | August 16, 2021 | ||||||
Actual Primary Completion Date | August 31, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 65 Years and older (Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02942888 | ||||||
Other Study ID Numbers ICMJE | HSC20160350H | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | The University of Texas Health Science Center at San Antonio | ||||||
Original Responsible Party | Becky Powers, The University of Texas Health Science Center at San Antonio, Assistant Professor, Medicine | ||||||
Current Study Sponsor ICMJE | The University of Texas Health Science Center at San Antonio | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | The University of Texas Health Science Center at San Antonio | ||||||
Verification Date | August 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |