Phase 2
N=52
NAD Therapy for Improving Memory and Brain Blood Flow in Older Adults With Mild Cognitive Impairment
Mild Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT03482167 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Cognitive Scores at Baseline and Week 12 — 96; 99; 101; 103 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Niagen® (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- University of Delaware
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cognitive Scores at Baseline and Week 12 |
96; 99; 101; 103; 93; 93 | — |
| SECONDARY Cerebrovascular Reactivity at Baseline and 12 Weeks |
3.2; 1.1; 4.2; 2.8 | — |
| SECONDARY Total Brain Blood Flow at Baseline and 12 Weeks |
47.1; 48.6; 47.4; 55.5 | — |
| SECONDARY Aortic Stiffness at Baseline and 12 Weeks |
8.9; 9.8; 8.5; 9.1 | — |
| SECONDARY Blood Pressure at Baseline and 12 Weeks |
124; 132; 123; 127; 70; 74 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03482167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.