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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 : February 7, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Delaware

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Drug: Niagen® Other: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: NAD Therapy for Improving Memory and Brain Blood Flow in Older Adults With Mild Cognitive Impairment
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Niacinamide

Arm Intervention/treatment
Placebo Comparator: Placebo
placebo
Other: Placebo
placebo

Experimental: Nicotinamide Riboside
Niagen® (ChromaDex, Inc.) 500 mg, twice daily
Drug: Niagen®
250 mg capsules (4 capsules daily)
Other Name: nicotinamide riboside chloride




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change from baseline in cerebrovascular reactivity at 12 weeks [ Time Frame: baseline and 12 weeks ]
    Cerebrovascular reactivity to hypercapnia

  2. Change from baseline in total brain blood flow at 12 weeks [ Time Frame: baseline and 12 weeks ]
    Total brain blood flow

  3. Change from baseline in aortic stiffness at 12 weeks [ Time Frame: baseline and 12 weeks ]
    Carotid-femoral pulse wave velocity (CFPWV)

  4. Change from baseline in blood pressure at 12 weeks [ Time Frame: baseline and 12 weeks ]
    systolic and diastolic blood pressure


Other Outcome Measures:
  1. Change from baseline in neurovascular coupling at 12 weeks [ Time Frame: baseline and 12 weeks ]
    Cerebrovascular reactivity to cognitive tasks

  2. Change from baseline in functional brain connectivity at 12 weeks [ Time Frame: baseline and 12 weeks ]
    functional brain connectivity assessed by MRI

  3. Change from baseline in neuronal activation at 12 weeks [ Time Frame: baseline and 12 weeks ]
    Functional MRI (fMRI) to cognitive task

  4. Change from baseline in brain volume at 12 weeks [ Time Frame: baseline and 12 weeks ]
    White and grey matter volume assessed by structural MRI



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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 >60 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482167


Contacts
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Contact: Joshua Hobson, M.S. 302-831-8137 chs-novalab@udel.edu

Locations
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United States, Delaware
Neurovascular Aging Laboratory Recruiting
Newark, Delaware, United States, 19713
Contact: Joshua Hobson, MS    302-831-8137    chs-novalab@udel.edu   
Principal Investigator: Christopher R Martens, Ph.D.         
Sponsors and Collaborators
University of Delaware
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Christopher R Martens, Ph.D. University of Delaware

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Responsible Party: University of Delaware
ClinicalTrials.gov Identifier: NCT03482167     History of Changes
Other Study ID Numbers: 1079271
K01AG054731 ( U.S. NIH Grant/Contract )
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Delaware:
blood pressure
arterial stiffness
cerebrovascular function
cognitive function

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents