Skip to main content
OpenTrials
Completed

NCT Number: NCT03482167

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Neurovascular Aging Laboratory

Newark, Delaware, 19713, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Niagen®

Drug

250 mg capsules (4 capsules daily)

Other names: nicotinamide riboside chloride

Placebo

Other

placebo

Primary outcomes

  1. 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:

    • 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. Aortic Stiffness at Baseline and 12 Weeks

    Time frame: baseline and 12 weeks

    Carotid-femoral pulse wave velocity (CFPWV)

  4. Blood Pressure at Baseline and 12 Weeks

    Time frame: baseline and 12 weeks

    Seated systolic and diastolic blood pressure assessed using automated oscillometric sphygmomanometer.

Other outcomes

  1. Neurovascular Coupling at Baseline and 12 Weeks

    Time frame: baseline and 12 weeks

    Cerebrovascular reactivity to cognitive tasks

  2. Functional Brain Connectivity at Baseline and 12 Weeks

    Time frame: baseline and 12 weeks

    functional brain connectivity assessed by MRI

  3. Neuronal Activation at Baseline and 12 Weeks

    Time frame: baseline and 12 weeks

    Functional MRI (fMRI) to cognitive task

  4. Brain Volume at Baseline and 12 Weeks

    Time frame: baseline and 12 weeks

    White and grey matter volume assessed by structural MRI

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Mar 29, 2018
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.