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

NCT ID: NCT02942888

Last Updated: 2021-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-30

Study Completion Date

2021-08-16

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).

Conditions

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Mild Cognitive Impairment NAD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Healthy control

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.

Group Type ACTIVE_COMPARATOR

Nicotinamide riboside

Intervention Type DIETARY_SUPPLEMENT

Oral administration of Niagen ramp up 250mg to 1g/day as tolerated

Sugar Pill

Intervention Type DIETARY_SUPPLEMENT

This is a placebo compounded by ChromaDex, Inc.

MCI

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.

Group Type EXPERIMENTAL

Nicotinamide riboside

Intervention Type DIETARY_SUPPLEMENT

Oral administration of Niagen ramp up 250mg to 1g/day as tolerated

Sugar Pill

Intervention Type DIETARY_SUPPLEMENT

This is a placebo compounded by ChromaDex, Inc.

Interventions

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Nicotinamide riboside

Oral administration of Niagen ramp up 250mg to 1g/day as tolerated

Intervention Type DIETARY_SUPPLEMENT

Sugar Pill

This is a placebo compounded by ChromaDex, Inc.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Niagen; ChromaDex, Inc.

Eligibility Criteria

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Inclusion Criteria

* Two week washout period for participants who were taking opioids or a dose of niacin over 200mg

Exclusion Criteria

* 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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas

OTHER

Sponsor Role collaborator

South Texas Veterans Health Care System

FED

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Becky Powers, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center in San Antonio

Locations

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South Texas Veterans Healthcare System (STVHCS)

San Antonio, Texas, United States

Site Status

University of Texas Health San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37994989 (View on PubMed)

Other Identifiers

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HSC20160350H

Identifier Type: -

Identifier Source: org_study_id

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