Back to resultsNAD Therapy for Improving Memory and Brain Blood Flow in Older Adults With Mild Cognitive Impairment
Primary Purpose
Mild Cognitive Impairment
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Niagen®
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring blood pressure, arterial stiffness, cerebrovascular function, cognitive function
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
Sites / Locations
- Neurovascular Aging Laboratory
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Nicotinamide Riboside
Arm Description
placebo
Niagen® (ChromaDex, Inc.) 500 mg, twice daily
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change from baseline in cerebrovascular reactivity at 12 weeks
Cerebrovascular reactivity to hypercapnia
Change from baseline in total brain blood flow at 12 weeks
Total brain blood flow
Change from baseline in aortic stiffness at 12 weeks
Carotid-femoral pulse wave velocity (CFPWV)
Change from baseline in blood pressure at 12 weeks
systolic and diastolic blood pressure
Full Information
NCT ID
NCT03482167
First Posted
February 14, 2018
Last Updated
October 9, 2023
Sponsor
University of Delaware
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT03482167
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
blood pressure, arterial stiffness, cerebrovascular function, cognitive function
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
Nicotinamide Riboside
Arm Type
Experimental
Arm Description
Niagen® (ChromaDex, Inc.) 500 mg, twice daily
Intervention Type
Drug
Intervention Name(s)
Niagen®
Other Intervention Name(s)
nicotinamide riboside chloride
Intervention Description
250 mg capsules (4 capsules daily)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Change from baseline in cognitive scores at 12 weeks
Description
change in one or more domains of cognitive function including: episodic memory, attention, working memory, processing speed, executive function and language abilities from baseline
Time Frame
baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in cerebrovascular reactivity at 12 weeks
Description
Cerebrovascular reactivity to hypercapnia
Time Frame
baseline and 12 weeks
Title
Change from baseline in total brain blood flow at 12 weeks
Description
Total brain blood flow
Time Frame
baseline and 12 weeks
Title
Change from baseline in aortic stiffness at 12 weeks
Description
Carotid-femoral pulse wave velocity (CFPWV)
Time Frame
baseline and 12 weeks
Title
Change from baseline in blood pressure at 12 weeks
Description
systolic and diastolic blood pressure
Time Frame
baseline and 12 weeks
Other Pre-specified Outcome Measures:
Title
Change from baseline in neurovascular coupling at 12 weeks
Description
Cerebrovascular reactivity to cognitive tasks
Time Frame
baseline and 12 weeks
Title
Change from baseline in functional brain connectivity at 12 weeks
Description
functional brain connectivity assessed by MRI
Time Frame
baseline and 12 weeks
Title
Change from baseline in neuronal activation at 12 weeks
Description
Functional MRI (fMRI) to cognitive task
Time Frame
baseline and 12 weeks
Title
Change from baseline in brain volume at 12 weeks
Description
White and grey matter volume assessed by structural MRI
Time Frame
baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher R Martens, Ph.D.
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurovascular Aging Laboratory
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
NAD Therapy for Improving Memory and Brain Blood Flow in Older Adults With Mild Cognitive Impairment
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