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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Other: Placebo; Drug: Niagen®

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Catherine Awad, B.S.; Phone Number: 302-831-8137; Email: chs-novalab@udel.edu

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change from baseline in cognitive scores at 12 weeks	change in one or more domains of cognitive function including: episodic memory, attention, working memory, processing speed, executive function and language abilities from baseline	baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in cerebrovascular reactivity at 12 weeks	Cerebrovascular reactivity to hypercapnia	baseline and 12 weeks
Change from baseline in total brain blood flow at 12 weeks	Total brain blood flow	baseline and 12 weeks
Change from baseline in aortic stiffness at 12 weeks	Carotid-femoral pulse wave velocity (CFPWV)	baseline and 12 weeks
Change from baseline in blood pressure at 12 weeks	systolic and diastolic blood pressure	baseline and 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in neurovascular coupling at 12 weeks	Cerebrovascular reactivity to cognitive tasks	baseline and 12 weeks
Change from baseline in functional brain connectivity at 12 weeks	functional brain connectivity assessed by MRI	baseline and 12 weeks
Change from baseline in neuronal activation at 12 weeks	Functional MRI (fMRI) to cognitive task	baseline and 12 weeks
Change from baseline in brain volume at 12 weeks	White and grey matter volume assessed by structural MRI	baseline and 12 weeks

Collaborators and Investigators

• Sponsor: University of Delaware
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Christopher R Martens, Ph.D., University of Delaware

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): January 8, 2024
• Study Completion (Actual): January 22, 2024

Study Registration Dates

• First Submitted: February 14, 2018
• First Submitted That Met QC Criteria: March 22, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: cognitive function; blood pressure; arterial stiffness; cerebrovascular function
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Niacinamide
• Other Study ID 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