NAD Therapy for Improving Memory and Brain Blood Flow in Older Adults With Mild Cognitive Impairment

April 2, 2025 updated by: Christopher Martens, University of Delaware
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19713
        • Neurovascular Aging Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • 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;

Exclusion Criteria

  • 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);
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
placebo
Other: Placebo
placebo
Experimental: Nicotinamide Riboside
Niagen® (ChromaDex, Inc.) 500 mg, twice daily
Drug: Niagen®
250 mg capsules (4 capsules daily)
Other Names:
  • nicotinamide riboside chloride

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
baseline and 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cerebrovascular Reactivity at Baseline and 12 Weeks
Time Frame: 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.
baseline and 12 weeks
Total Brain Blood Flow at Baseline and 12 Weeks
Time Frame: 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.
baseline and 12 weeks
Aortic Stiffness at Baseline and 12 Weeks
Time Frame: baseline and 12 weeks
Carotid-femoral pulse wave velocity (CFPWV)
baseline and 12 weeks
Blood Pressure at Baseline and 12 Weeks
Time Frame: baseline and 12 weeks
Seated systolic and diastolic blood pressure assessed using automated oscillometric sphygmomanometer.
baseline and 12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neurovascular Coupling at Baseline and 12 Weeks
Time Frame: baseline and 12 weeks
Cerebrovascular reactivity to cognitive tasks
baseline and 12 weeks
Functional Brain Connectivity at Baseline and 12 Weeks
Time Frame: baseline and 12 weeks
functional brain connectivity assessed by MRI
baseline and 12 weeks
Neuronal Activation at Baseline and 12 Weeks
Time Frame: baseline and 12 weeks
Functional MRI (fMRI) to cognitive task
baseline and 12 weeks
Brain Volume at Baseline and 12 Weeks
Time Frame: baseline and 12 weeks
White and grey matter volume assessed by structural MRI
baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Delaware

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher R Martens, Ph.D., University of Delaware

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 8, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1079271
  • K01AG054731 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Dietary Supplements

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