Clinical trial NCT03482167: NAD Therapy for Improving Memory and Brain Blood Flow in Older Adults With Mild Cognitive Impairment
Official title: NAD Therapy for Improving Memory and Brain Blood Flow in Older Adults With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Mild Cognitive Impairment
Keywords: blood pressure
arterial stiffness
cerebrovascular function
cognitive function
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-03-29
Enrollment: 64
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Cognitive Scores at Baseline and Week 12
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Cerebrovascular Reactivity at Baseline and 12 Weeks
timeFrame: baseline and 12 weeks
measure: Total Brain Blood Flow at Baseline and 12 Weeks
timeFrame: baseline and 12 weeks
measure: Aortic Stiffness at Baseline and 12 Weeks
timeFrame: baseline and 12 weeks
measure: Blood Pressure at Baseline and 12 Weeks
timeFrame: baseline and 12 weeks
Other outcomes:
measure: Neurovascular Coupling at Baseline and 12 Weeks
timeFrame: baseline and 12 weeks
measure: Functional Brain Connectivity at Baseline and 12 Weeks
timeFrame: baseline and 12 weeks
measure: Neuronal Activation at Baseline and 12 Weeks
timeFrame: baseline and 12 weeks
measure: Brain Volume at Baseline and 12 Weeks
timeFrame: baseline and 12 weeks
Locations:
city: Newark
country: United States
facility: Neurovascular Aging Laboratory
state: Delaware
Study officials:
affiliation: University of Delaware
name: Christopher R Martens, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: