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

Study Overview
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Brief Summary
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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.

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

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Drug: Niagen®
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>placebo | Other: Placebo<br>* placebo<br>|
| Experimental: Nicotinamide Riboside<br>Niagen® (ChromaDex, Inc.) 500 mg, twice daily | Drug: Niagen®<br>* 250 mg capsules (4 capsules daily)<br>* Other names: nicotinamide riboside chloride;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood pressure, arterial stiffness, cerebrovascular function, cognitive function