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

• ClinicalTrials.gov Identifier: NCT03482167
• Recruitment Status: Recruiting
• First Posted: March 29, 2018
• Last Update Posted: August 31, 2022
• Sponsor: University of Delaware
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Christopher Martens, University of Delaware

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Mild Cognitive Impairment	Drug: Niagen®; Other: Placebo	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Double-blind
• Primary Purpose: Treatment
• Official Title: NAD Therapy for Improving Memory and Brain Blood Flow in Older Adults With Mild Cognitive Impairment
• Actual Study Start Date: December 1, 2018
• Estimated Primary Completion Date: December 31, 2023
• Estimated Study Completion Date: December 31, 2023

Arms and Interventions

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 Name: nicotinamide riboside chloride

Outcome Measures

Primary Outcome Measures :

1. Change from baseline in cognitive scores at 12 weeks [ Time Frame: baseline and 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

Secondary Outcome Measures :

1. Change from baseline in cerebrovascular reactivity at 12 weeks [ Time Frame: baseline and 12 weeks ]
   Cerebrovascular reactivity to hypercapnia
2. Change from baseline in total brain blood flow at 12 weeks [ Time Frame: baseline and 12 weeks ]
   Total brain blood flow
3. Change from baseline in aortic stiffness at 12 weeks [ Time Frame: baseline and 12 weeks ]
   Carotid-femoral pulse wave velocity (CFPWV)
4. Change from baseline in blood pressure at 12 weeks [ Time Frame: baseline and 12 weeks ]
   systolic and diastolic blood pressure

Other Outcome Measures:

1. Change from baseline in neurovascular coupling at 12 weeks [ Time Frame: baseline and 12 weeks ]
   Cerebrovascular reactivity to cognitive tasks
2. Change from baseline in functional brain connectivity at 12 weeks [ Time Frame: baseline and 12 weeks ]
   functional brain connectivity assessed by MRI
3. Change from baseline in neuronal activation at 12 weeks [ Time Frame: baseline and 12 weeks ]
   Functional MRI (fMRI) to cognitive task
4. Change from baseline in brain volume at 12 weeks [ Time Frame: baseline and 12 weeks ]
   White and grey matter volume assessed by structural MRI

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Catherine Awad, B.S.; 302-831-8137; chs-novalab@udel.edu

Locations

United States, Delaware

Neurovascular Aging Laboratory; Recruiting

Newark, Delaware, United States, 19713

Contact: Christopher R Martens, Ph.D. 302-831-7270 chs-novalab@udel.edu

Principal Investigator: Christopher R Martens, Ph.D.

Sponsors and Collaborators

University of Delaware

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Christopher R Martens, Ph.D.; University of Delaware

More Information

• Responsible Party: Christopher Martens, Assistant Professor, University of Delaware
• ClinicalTrials.gov Identifier: NCT03482167
• Other Study ID Numbers: 1079271; K01AG054731 ( U.S. NIH Grant/Contract )
• First Posted: March 29, 2018
• Last Update Posted: August 31, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christopher Martens, University of Delaware:

blood pressure; arterial stiffness; cerebrovascular function; cognitive function

Additional relevant MeSH terms:

Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Niacinamide; Vitamin B Complex; Vitamins; Micronutrients; Physiological Effects of Drugs