Mild Cognitive Impairment Clinical Trial
Official title:
NAD Therapy for Improving Memory and Brain Blood Flow in Older Adults With Mild Cognitive Impairment
Verified date | January 2024 |
Source | University of Delaware |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | January 22, 2024 |
Est. primary completion date | January 8, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Neurovascular Aging Laboratory | Newark | Delaware |
Lead Sponsor | Collaborator |
---|---|
University of Delaware | National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change from baseline in neurovascular coupling at 12 weeks | Cerebrovascular reactivity to cognitive tasks | baseline and 12 weeks | |
Other | Change from baseline in functional brain connectivity at 12 weeks | functional brain connectivity assessed by MRI | baseline and 12 weeks | |
Other | Change from baseline in neuronal activation at 12 weeks | Functional MRI (fMRI) to cognitive task | baseline and 12 weeks | |
Other | Change from baseline in brain volume at 12 weeks | White and grey matter volume assessed by structural MRI | baseline and 12 weeks | |
Primary | 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 | Change from baseline in cerebrovascular reactivity at 12 weeks | Cerebrovascular reactivity to hypercapnia | baseline and 12 weeks | |
Secondary | Change from baseline in total brain blood flow at 12 weeks | Total brain blood flow | baseline and 12 weeks | |
Secondary | Change from baseline in aortic stiffness at 12 weeks | Carotid-femoral pulse wave velocity (CFPWV) | baseline and 12 weeks | |
Secondary | Change from baseline in blood pressure at 12 weeks | systolic and diastolic blood pressure | baseline and 12 weeks |
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