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

Mild Cognitive Impairment Clinical Trial

— NAD  

Official title:

The Effects of NAD on Brain Function and Cognition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02942888
• Other study ID #: HSC20160350H
• Status: Completed
• Phase: N/A
• Start date: November 30, 2017
• Est. completion date: August 16, 2021

Study information

• Verified date: August 2021
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 16, 2021
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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 exclusion criteria of the TARCC study (IRB: HSC20090535H).
• 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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment
• NAD

Intervention

Dietary Supplement:
• Nicotinamide riboside
Oral administration of Niagen ramp up 250mg to 1g/day as tolerated
• Sugar Pill
This is a placebo compounded by ChromaDex, Inc.

Locations

Country	Name	City	State
United States	South Texas Veterans Healthcare System (STVHCS)	San Antonio	Texas
United States	University of Texas Health San Antonio	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	South Texas Veterans Health Care System, University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cognitive Assessment - Montreal Cognitive Assessment (MoCA) - from baseline at 10 weeks	MoCA Value	10 weeks
Secondary	Change in cerebral blood flow from baseline at 10 weeks	functional Magnetic Resonance Imaging (fMRI)	10 weeks
Secondary	Change in plasma NAD from baseline at 10 weeks	Plasma NAD level	10 weeks
Secondary	Change in Physical Performance - Short Physical Performance Battery (SPPB) - from baseline at 10 weeks	SPPB Score	10 weeks
Secondary	Change in Physical Performance - Instrumental Activities of Daily Living (IADLs) - from baseline at 10 weeks	IADL Score	10 weeks
Secondary	Change in endothelial function from baseline at 10 weeks	Arterial Pressure	10 weeks
Secondary	Change in Cognitive Assessment - Geriatric Depression Scale (GDS) - from baseline at 10 weeks	GDS Value (>/= 5 is abnormal)	10 weeks
Secondary	Change in Cognitive Assessment - Geriatric Anxiety Scale (GAS) - from baseline at 10 weeks	GAS Value (Raw score 1 -30)	10 weeks
Secondary	Change in Cognitive Assessment - Clock Drawing Task Protocol (CLOX) - from baseline at 10 weeks	CLOX Value (Score 0-15)	10 weeks
Secondary	Change in Cognitive Assessment - Executive Interview (EXIT) - from baseline at 10 weeks	EXIT Value (Score 0-50)	10 weeks
Secondary	Change in Cognitive Assessment - Test of Auditory Processing Skills (TAPS) - from baseline at 10 weeks	TAPS Score	10 weeks
Secondary	Change in Physical Performance - Grip Strength - from baseline at 10 weeks	Grip Strength (kgs)	10 weeks