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

University of Delaware

Status and phase: Completed; Phase 2; Phase 1

Conditions: Mild Cognitive Impairment

Treatments: Drug: Niagen®; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03482167

K01AG054731 (U.S. NIH Grant/Contract)

1079271

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

placebo

Treatment:

Other: Placebo

Nicotinamide Riboside

Experimental group

Description:

Niagen® (ChromaDex, Inc.) 500 mg, twice daily

Treatment:

Drug: Niagen®