NCT02942888

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 30, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2021

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

1.8 years

First QC Date

August 29, 2016

Last Update Submit

August 31, 2021

Conditions

Mild Cognitive ImpairmentNAD

Keywords

Mild Cognitive ImpairmentMCINADnicotinamide ribosideaging

Outcome Measures

Primary Outcomes (1)

  • Change in Cognitive Assessment - Montreal Cognitive Assessment (MoCA) - from baseline at 10 weeks

    MoCA Value

    10 weeks

Secondary Outcomes (11)

  • Change in cerebral blood flow from baseline at 10 weeks

    10 weeks

  • Change in plasma NAD from baseline at 10 weeks

    10 weeks

  • Change in Physical Performance - Short Physical Performance Battery (SPPB) - from baseline at 10 weeks

    10 weeks

  • Change in Physical Performance - Instrumental Activities of Daily Living (IADLs) - from baseline at 10 weeks

    10 weeks

  • Change in endothelial function from baseline at 10 weeks

    10 weeks

  • +6 more secondary outcomes

Study Arms (2)

Healthy control

ACTIVE COMPARATOR

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.

Dietary Supplement: Nicotinamide ribosideDietary Supplement: Sugar Pill

MCI

EXPERIMENTAL

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.

Dietary Supplement: Nicotinamide ribosideDietary Supplement: Sugar Pill

Interventions

Nicotinamide ribosideDIETARY_SUPPLEMENT

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

Also known as: Niagen; ChromaDex, Inc.
Healthy controlMCI
Sugar PillDIETARY_SUPPLEMENT

This is a placebo compounded by ChromaDex, Inc.

Healthy controlMCI

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

South Texas Veterans Healthcare System (STVHCS)

San Antonio, Texas, 78229, United States

Location

University of Texas Health San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • 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.

    PMID: 37994989DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

nicotinamide-beta-ribosideSugars

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Becky Powers, M.D.

    University of Texas Health Science Center in San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2016

First Posted

October 24, 2016

Study Start

November 30, 2017

Primary Completion

August 31, 2019

Study Completion

August 16, 2021

Last Updated

September 2, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)