Clinical trial NCT02942888: The Effects of Nicotinamide Adenine Dinucleotide (NAD) on Brain Function and Cognition
Official title: The Effects of NAD on Brain Function and Cognition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
NAD
Keywords: Mild Cognitive Impairment
MCI
NAD
nicotinamide riboside
aging
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: University of Texas
name: South Texas Veterans Health Care System
First posted: 2016-10-24
Enrollment: 46
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Cognitive Assessment - Montreal Cognitive Assessment (MoCA) - from baseline at 10 weeks
timeFrame: 10 weeks
Secondary outcomes:
measure: Change in cerebral blood flow from baseline at 10 weeks
timeFrame: 10 weeks
measure: Change in plasma NAD from baseline at 10 weeks
timeFrame: 10 weeks
measure: Change in Physical Performance - Short Physical Performance Battery (SPPB) - from baseline at 10 weeks
timeFrame: 10 weeks
measure: Change in Physical Performance - Instrumental Activities of Daily Living (IADLs) - from baseline at 10 weeks
timeFrame: 10 weeks
measure: Change in endothelial function from baseline at 10 weeks
timeFrame: 10 weeks
measure: Change in Cognitive Assessment - Geriatric Depression Scale (GDS) - from baseline at 10 weeks
timeFrame: 10 weeks
measure: Change in Cognitive Assessment - Geriatric Anxiety Scale (GAS) - from baseline at 10 weeks
timeFrame: 10 weeks
measure: Change in Cognitive Assessment - Clock Drawing Task Protocol (CLOX) - from baseline at 10 weeks
timeFrame: 10 weeks
measure: Change in Cognitive Assessment - Executive Interview (EXIT) - from baseline at 10 weeks
timeFrame: 10 weeks
measure: Change in Cognitive Assessment - Test of Auditory Processing Skills (TAPS) - from baseline at 10 weeks
timeFrame: 10 weeks
measure: Change in Physical Performance - Grip Strength - from baseline at 10 weeks
timeFrame: 10 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: South Texas Veterans Healthcare System (STVHCS)
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health Science Center in San Antonio
name: Becky Powers, M.D.
role: PRINCIPAL_INVESTIGATOR
References: