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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03482167
• Other study ID #: 1079271
• Secondary ID: K01AG054731
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 1, 2018
• Est. completion date: January 22, 2024

Study information

• Verified date: January 2024
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Drug:
• Niagen®
250 mg capsules (4 capsules daily)

Other:
• Placebo
placebo

Locations

Country	Name	City	State
United States	Neurovascular Aging Laboratory	Newark	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
University of Delaware	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

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