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

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ClinicalTrials.gov Identifier: NCT03482167
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Christopher Martens, University of Delaware

Tracking Information
First Submitted Date  ICMJE February 14, 2018
First Posted Date  ICMJE March 29, 2018
Last Update Posted Date March 26, 2020
Actual Study Start Date  ICMJE December 1, 2018
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
Change from baseline in cognitive scores at 12 weeks [ Time Frame: baseline and 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
  • Change from baseline in cerebrovascular reactivity at 12 weeks [ Time Frame: baseline and 12 weeks ]
    Cerebrovascular reactivity to hypercapnia
  • Change from baseline in total brain blood flow at 12 weeks [ Time Frame: baseline and 12 weeks ]
    Total brain blood flow
  • Change from baseline in aortic stiffness at 12 weeks [ Time Frame: baseline and 12 weeks ]
    Carotid-femoral pulse wave velocity (CFPWV)
  • Change from baseline in blood pressure at 12 weeks [ Time Frame: baseline and 12 weeks ]
    systolic and diastolic blood pressure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 22, 2018)
  • Change from baseline in neurovascular coupling at 12 weeks [ Time Frame: baseline and 12 weeks ]
    Cerebrovascular reactivity to cognitive tasks
  • Change from baseline in functional brain connectivity at 12 weeks [ Time Frame: baseline and 12 weeks ]
    functional brain connectivity assessed by MRI
  • Change from baseline in neuronal activation at 12 weeks [ Time Frame: baseline and 12 weeks ]
    Functional MRI (fMRI) to cognitive task
  • Change from baseline in brain volume at 12 weeks [ Time Frame: baseline and 12 weeks ]
    White and grey matter volume assessed by structural MRI
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE NAD Therapy for Improving Memory and Brain Blood Flow in Older Adults With Mild Cognitive Impairment
Official Title  ICMJE NAD Therapy for Improving Memory and Brain Blood Flow in Older Adults With Mild Cognitive Impairment
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double-blind
Primary Purpose: Treatment
Condition  ICMJE Mild Cognitive Impairment
Intervention  ICMJE
  • Drug: Niagen®
    250 mg capsules (4 capsules daily)
    Other Name: nicotinamide riboside chloride
  • Other: Placebo
    placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    placebo
    Intervention: Other: Placebo
  • Experimental: Nicotinamide Riboside
    Niagen® (ChromaDex, Inc.) 500 mg, twice daily
    Intervention: Drug: Niagen®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 22, 2018)
58
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
  • systemic medical illnesses (e.g. cardiovascular disease, cancer, renal failure);
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Joshua Hobson, M.S. 302-831-8137 chs-novalab@udel.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03482167
Other Study ID Numbers  ICMJE 1079271
K01AG054731 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Christopher Martens, University of Delaware
Study Sponsor  ICMJE University of Delaware
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Christopher R Martens, Ph.D. University of Delaware
PRS Account University of Delaware
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP