Mild Cognitive ImpairmentPhase 1/2NCT03482167
NAD Therapy for Improving Memory and Brain Blood Flow in Older Adults With Mild Cognitive Impairment
A Phase 1/2 study testing Niagen® in people with Mild Cognitive Impairment, run by University of Delaware at 1 site in United States.
Trial summary
This study will provide insight into whether a nutritional supplement, nicotinamide riboside (NR), improves memory and brain blood flow in older adults with low memory abilities. Overall, this project has the potential to identify a novel, safe and cost-effective strategy for decreasing age-related memory loss. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Niagen®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2019to 22 Jan 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cognitive function scores consistent with amnestic mild cognitive impairment based on pre-screening evaluation;
- age 60-90 years;
- MMSE score >24 at time of initial consent;
Who cannot join
- blood chemistries indicative of abnormal renal, liver, thyroid and adrenal function; estimated glomerular filtration rate using the MDRD prediction equation must be >30 ml/min/1.73 m2;
- any clinically significant abnormal blood chemistry values as determined by the research nurse or NMPCC nurse practitioner;
- major psychiatric disorder (e.g. schizophrenia, bipolar disorder, major depression within past two years);
- neurological or autoimmune conditions affecting cognition (e.g. Parkinson's disease, epilepsy, multiple sclerosis, mild or severe traumatic brain injury, large vessel infarct);
- concussion within last 2 years and ≥ 3 lifetime concussions;
- current systemic medical illnesses (e.g. cardiovascular disease, cancer, renal failure);
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- prior history of any type of cancer;
- substance abuse or dependence (DSM-V criteria);
- current use of medications used to treat dementia (e.g., anticholinesterase drugs) or other drugs likely to affect cognition (e.g., anticholinergic drugs, long-acting benzodiazepines);
- claustrophobia, metal implants, pacemaker or other factors affecting feasibility and/or safety of MRI scanning*;
- current smoking (including marijuana) within the past 3 months;
- hospitalization as a result of COVID-19
Trial locations and contacts
1 site in 1 country.
United States1 site
Neurovascular Aging Laboratory
Newark, Delaware, 19713
About this study
This study will provide insight into whether a nutritional supplement, nicotinamide riboside (NR), improves memory and brain blood flow in older adults with low memory abilities. Overall, this project has the potential to identify a novel, safe and cost-effective strategy for decreasing age-related memory loss.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Niagen®, Placebo
- Keywords
- blood pressure, arterial stiffness, cerebrovascular function, cognitive function
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niagen®Drug
Also called nicotinamide riboside chloride
250 mg capsules (4 capsules daily)
PlaceboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo Receives: Other: Placebo |
| Nicotinamide Riboside | Experimental | Niagen® (ChromaDex, Inc.) 500 mg, twice daily Receives: Drug: Niagen® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Scores at Baseline and Week 12
Primary outcome was a change from baseline in any domain of cognitive function. For all outcomes, a higher score indicates better cognitive function:
- California Verbal Learning Test III (CVLT-III) Index Scores. Ability learn and recall a list of words over 5 trials and again after a 20 minute delay. Each Index Score has a mean of 100 and a standard deviation of 15 based on normative dataset (Range = 55 - 145).
- Wechsler Memory Scale IV (WMS-IV) Raw Scores.
- Logical Memory I \& II: Range = 0-50
- Logical Memory II Recognition: Range = 0-30
- Visual Reproduction I \& II: Range = 0-43
- Visual Reproduction II Recognition Score: Range = 0-7
- NIH Toolbox Fluid Composite Score. Composite Score has a mean of 100 and a standard deviation of 15 based on normative dataset (Range = 55 - 145) - based on several tests of fluid and crystallized cognition (episodic memory, attention, working memory, processing speed, executive function and language abilities).
Measured: baseline and 12 weeks
Secondary outcomes (4)
Cerebrovascular Reactivity at Baseline and 12 Weeks
Relative (percent) change in blood velocity of the middle cerebral artery (MCA) per mmHg change in end-tidal carbon dioxide (ETCO2) during a brief period of hypercapnia.
Hypercapnia was induced by prospective end-tidal targeting (RespirAct, Thornhill Medical) in which a target change in end-tidal CO2 of +9mmHg was set. Data were only analyzed if ETCO2 changed by at least 6mmHg. All data were then normalized to the absolute change in ETCO2.
Measured: baseline and 12 weeks
Total Brain Blood Flow at Baseline and 12 Weeks
Total brain blood flow assessed by pseudo-continuous arterial spin labeling (pcASL). Total brain blood flow is measured in milliliters of blood per minute per 100 grams of brain tissue.
Measured: baseline and 12 weeks
Aortic Stiffness at Baseline and 12 Weeks
Carotid-femoral pulse wave velocity (CFPWV)
Measured: baseline and 12 weeks
Blood Pressure at Baseline and 12 Weeks
Seated systolic and diastolic blood pressure assessed using automated oscillometric sphygmomanometer.
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start20 Mar 2019
- Primary completion8 Jan 2024
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Christopher Martens, University of Delaware
- Investigators
- Christopher R Martens, Ph.D., Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482167
- Sponsor's protocol ID
- 1079271
- Other IDs
- K01AG054731
- Status last verified
- Apr 2025
- First submitted
- 14 Feb 2018
- Last updated
- 4 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NAD Therapy for Improving Memory and Brain Blood Flow in Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03482167
- Acronym / sponsor ID
- 1079271
- Conditions
- Mild Cognitive Impairment
- Keywords
- blood pressure, arterial stiffness, cerebrovascular function, cognitive function
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Posted 4 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will provide insight into whether a nutritional supplement, nicotinamide riboside (NR), improves memory and brain blood flow in older adults with low memory abilities. Overall, this project has the potential to identify a novel, safe and cost-effective strategy for decreasing age-related memory loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placeboplacebo |
| Nicotinamide Riboside | Experimental | Drug: Niagen®Niagen® (ChromaDex, Inc.) 500 mg, twice daily |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cognitive function scores consistent with amnestic mild cognitive impairment based on pre-screening evaluation;
- age 60-90 years;
- MMSE score >24 at time of initial consent;
Key exclusion criteria (12 listed)
- blood chemistries indicative of abnormal renal, liver, thyroid and adrenal function; estimated glomerular filtration rate using the MDRD prediction equation must be >30 ml/min/1.73 m2;
- any clinically significant abnormal blood chemistry values as determined by the research nurse or NMPCC nurse practitioner;
- major psychiatric disorder (e.g. schizophrenia, bipolar disorder, major depression within past two years);
- neurological or autoimmune conditions affecting cognition (e.g. Parkinson's disease, epilepsy, multiple sclerosis, mild or severe traumatic brain injury, large vessel infarct);
- concussion within last 2 years and ≥ 3 lifetime concussions;
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 |
|---|---|---|
| Niagen®Also: nicotinamide riboside chloride250 mg capsules (4 capsules daily) | Drug | Nicotinamide Riboside |
| Placeboplacebo | Other | Placebo |
Primary outcome
Cognitive Scores at Baseline and Week 12
Time frame: baseline and 12 weeks
Primary outcome was a change from baseline in any domain of cognitive function. For all outcomes, a higher score indicates better cognitive function: 1. California Verbal Learning Test III (CVLT-III) Index Scores. Ability learn and recall a list of words over 5 trials and again after a 20 minute delay. Each Index Score has a mean of 100 and a standard deviation of 15 based on normative dataset (Range = 55 - 145). 2. Wechsler Memory Scale IV (WMS-IV) Raw Scores. * Logical Memory I \& II: Range = 0-50 * Logical Memory II Recognition: Range = 0-30 * Visual Reproduction I \& II: Range = 0-43 * Visual Reproduction II Recognition Score: Range = 0-7 3. NIH Toolbox Fluid Composite Score. Composite Score has a mean of 100 and a standard deviation of 15 based on normative dataset (Range = 55 - 145) - based on several tests of fluid and crystallized cognition (episodic memory, attention, working memory, processing speed, executive function and language abilities).
4 secondary outcomes
Cerebrovascular Reactivity at Baseline and 12 Weeks
Time frame: baseline and 12 weeks
Total Brain Blood Flow at Baseline and 12 Weeks
Time frame: baseline and 12 weeks
Aortic Stiffness at Baseline and 12 Weeks
Time frame: baseline and 12 weeks
Blood Pressure at Baseline and 12 Weeks
Time frame: baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Christopher R Martens, Ph.D. principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Niagen® in people with Mild Cognitive Impairment, run by University of Delaware at 1 site 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 3 inclusion and 12 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 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cognitive Scores at Baseline and Week 12 (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2025.