Mild Cognitive ImpairmentNADNCT02942888
The Effects of Nicotinamide Adenine Dinucleotide (NAD) on Brain Function and Cognition
A study testing Nicotinamide riboside and Sugar Pill in people with Mild Cognitive Impairment and NAD, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, NAD
- What is being tested?
- Nicotinamide riboside and Sugar Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Nov 2017to 16 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
South Texas Veterans Healthcare System (STVHCS)
San Antonio, Texas, 78229
University of Texas Health San Antonio
San Antonio, Texas, 78229
About this study
Official title: The Effects of NAD on Brain Function and Cognition
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).
Read the 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).
- Conditions
- Mild Cognitive Impairment, NAD
- Being tested
- Nicotinamide riboside, Sugar Pill
- Keywords
- Mild Cognitive Impairment, MCI, NAD, nicotinamide riboside, aging
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide ribosideDietary supplement
Also called Niagen; ChromaDex, Inc.
Oral administration of Niagen ramp up 250mg to 1g/day as tolerated
Sugar PillDietary supplement
This is a placebo compounded by ChromaDex, Inc.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Nicotinamide riboside; Dietary 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. Receives: Dietary Supplement: Nicotinamide riboside; Dietary Supplement: Sugar Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Assessment - Montreal Cognitive Assessment (MoCA) - from baseline at 10 weeks
MoCA Value
Measured: 10 weeks
Secondary outcomes (11)
Change in cerebral blood flow from baseline at 10 weeks
functional Magnetic Resonance Imaging (fMRI)
Measured: 10 weeks
Change in plasma NAD from baseline at 10 weeks
Plasma NAD level
Measured: 10 weeks
Change in Physical Performance - Short Physical Performance Battery (SPPB) - from baseline at 10 weeks
SPPB Score
Measured: 10 weeks
Change in Physical Performance - Instrumental Activities of Daily Living (IADLs) - from baseline at 10 weeks
IADL Score
Measured: 10 weeks
Change in endothelial function from baseline at 10 weeks
Arterial Pressure
Measured: 10 weeks
Change in Cognitive Assessment - Geriatric Depression Scale (GDS) - from baseline at 10 weeks
GDS Value (>/= 5 is abnormal)
Measured: 10 weeks
Change in Cognitive Assessment - Geriatric Anxiety Scale (GAS) - from baseline at 10 weeks
GAS Value (Raw score 1 -30)
Measured: 10 weeks
Change in Cognitive Assessment - Clock Drawing Task Protocol (CLOX) - from baseline at 10 weeks
CLOX Value (Score 0-15)
Measured: 10 weeks
Change in Cognitive Assessment - Executive Interview (EXIT) - from baseline at 10 weeks
EXIT Value (Score 0-50)
Measured: 10 weeks
Change in Cognitive Assessment - Test of Auditory Processing Skills (TAPS) - from baseline at 10 weeks
TAPS Score
Measured: 10 weeks
Change in Physical Performance - Grip Strength - from baseline at 10 weeks
Grip Strength (kgs)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start30 Nov 2017
- Primary completion31 Aug 2019
- Study completion16 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas, South Texas Veterans Health Care System
- Responsible party
- Sponsor
- Investigators
- Becky Powers, M.D., Principal investigator, University of Texas Health Science Center in San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942888
- Sponsor's protocol ID
- HSC20160350H
- Acronym
- NAD
- Status last verified
- Aug 2021
- First submitted
- 29 Aug 2016
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37994989
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of NAD on Brain Function and Cognition
- ClinicalTrials.gov ID
- NCT02942888
- Acronym / sponsor ID
- NAD / HSC20160350H
- Conditions
- Mild Cognitive Impairment, NAD
- Keywords
- Mild Cognitive Impairment, MCI, NAD, nicotinamide riboside, aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- University of Texas, South Texas Veterans Health Care System
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy control | Active comparator | Dietary Supplement: Nicotinamide riboside, Dietary Supplement: Sugar PillOral 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. |
| MCI | Experimental | Dietary Supplement: Nicotinamide riboside, Dietary Supplement: Sugar PillOral 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotinamide ribosideAlso: Niagen; ChromaDex, Inc.Oral administration of Niagen ramp up 250mg to 1g/day as tolerated | Dietary supplement | Healthy control, MCI |
| Sugar PillThis is a placebo compounded by ChromaDex, Inc. | Dietary supplement | Healthy control, MCI |
Primary outcome
Change in Cognitive Assessment - Montreal Cognitive Assessment (MoCA) - from baseline at 10 weeks
Time frame: 10 weeks
MoCA Value
11 secondary outcomes
Change in cerebral blood flow from baseline at 10 weeks
Time frame: 10 weeks
Change in plasma NAD from baseline at 10 weeks
Time frame: 10 weeks
Change in Physical Performance - Short Physical Performance Battery (SPPB) - from baseline at 10 weeks
Time frame: 10 weeks
Change in Physical Performance - Instrumental Activities of Daily Living (IADLs) - from baseline at 10 weeks
Time frame: 10 weeks
Change in endothelial function from baseline at 10 weeks
Time frame: 10 weeks
Change in Cognitive Assessment - Geriatric Depression Scale (GDS) - from baseline at 10 weeks
Time frame: 10 weeks
Change in Cognitive Assessment - Geriatric Anxiety Scale (GAS) - from baseline at 10 weeks
Time frame: 10 weeks
Change in Cognitive Assessment - Clock Drawing Task Protocol (CLOX) - from baseline at 10 weeks
Time frame: 10 weeks
Change in Cognitive Assessment - Executive Interview (EXIT) - from baseline at 10 weeks
Time frame: 10 weeks
Change in Cognitive Assessment - Test of Auditory Processing Skills (TAPS) - from baseline at 10 weeks
Time frame: 10 weeks
Change in Physical Performance - Grip Strength - from baseline at 10 weeks
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Derived from this study: PubMed 37994989Orr 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Becky Powers, M.D. principal investigator
University of Texas Health Science Center in San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotinamide riboside and Sugar Pill in people with Mild Cognitive Impairment and NAD, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Assessment - Montreal Cognitive Assessment (MoCA) - from baseline at 10 weeks (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02942888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.