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Mechanisms of Impaired Brain Blood Flow With Aging

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ClinicalTrials.gov Identifier: NCT03775382
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Christopher Martens, University of Delaware

Brief Summary:
Aging is the primary risk factor for Alzheimer's disease (AD), which is a rapidly growing public health concern. Understanding the mechanisms of normal brain aging may provide insight into the factors linking advancing age to increased risk for AD and thereby lead to new therapeutic targets for preventing or slowing AD progression. Cardiovascular changes, including impaired cerebrovascular function, occur with aging and may increase risk for AD; however, the mechanisms by which cerebrovascular function becomes impaired in older adults are incompletely understood. The overall goal of this project is to examine potential mechanisms of age-related declines in cerebrovascular function in humans. The investigators hypothesize that brain macro-vascular endothelial dysfunction, secondary to oxidative stress, plays an important role in mediating age-related changes in brain blood flow and cerebrovascular reactivity. The results of this pilot study have the potential to identify novel targets of cerebrovascular aging and will help guide the design of future clinical trials aimed at improving cerebral blood flow in older adults.

Condition or disease Intervention/treatment Phase
Aging Other: Ascorbic Acid Other: Normal Saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Mechanisms of Impaired Brain Blood Flow With Aging
Actual Study Start Date : October 30, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arm Intervention/treatment
Placebo Comparator: Placebo
Normal saline will be infused by the research nurse into an antecubital vein using an IV infusion pump.
Other: Normal Saline
Normal saline will be infused by the research nurse into an antecubital vein using an IV infusion pump.

Active Comparator: Ascorbic Acid
Ascorbic acid will be measured into sterile syringes by the research nurse and infused into an antecubital vein using a IV infusion pump beginning with a priming bolus of 0.06 g Ascorbic Acid per kg fat-free mass dissolved in 100 ml of saline or lactated ringers followed by a "drip-infusion" of 0.02 g Ascorbic Acid per kg fat-free mass dissolved in 30 ml of saline.
Other: Ascorbic Acid
Ascorbic acid will be infused into an antecubital vein using a IV infusion pump beginning with a priming bolus of 0.06 g Ascorbic Acid per kg fat-free mass dissolved in 100 ml of saline followed by a "drip-infusion" of 0.02 g Ascorbic Acid per kg fat-free mass dissolved in 30 ml of saline.
Other Name: Vitamin C




Primary Outcome Measures :
  1. Change from baseline in internal carotid artery (ICA) diameter after acute infusion of the antioxidant ascorbic acid [ Time Frame: Change from baseline to 30 minutes post-infusion ]
    Cerebrovascular reactivity to hypercapnia


Secondary Outcome Measures :
  1. Change from baseline in middle cerebral artery (MCA) diameter after acute infusion of the antioxidant ascorbic acid [ Time Frame: Change from baseline to 30 minutes post-infusion ]
    Cerebrovascular reactivity to hypercapnia



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-29 or 55-79 years old

Exclusion Criteria:

  • Pregnancy or breastfeeding;
  • Blood chemistries indicative of abnormal renal, liver, thyroid and adrenal function (i.e., outside of normal reference range); estimated glomerular filtration rate using the MDRD prediction equation must be >60 ml/min/1.73 m2;
  • Abnormal blood chemistry that is clinically relevant or any blood chemistry marker that is +/-2.5x the upper or lower limit;
  • Lack of a suitable temporal window for cerebrovascular assessments;
  • Current smoking;
  • Chronic clinical diseases (e.g., coronary artery, peripheral artery, or cerebrovascular diseases, diabetes, chronic kidney disease, COPD);
  • Major psychiatric disorder (e.g. Alzheimer's disease or other form of dementia, schizophrenia, bipolar disorder, major depression within past two years);
  • Neurological or autoimmune conditions affecting cognition (e.g. Parkinson's disease, epilepsy, multiple sclerosis, head trauma with loss of consciousness greater than 30 min, large vessel infarct);
  • Current medication use likely to affect CNS functions (e.g. long active benzodiazepines);
  • Having past or present alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual of Mental Disorders;
  • Body mass index (BMI) >40 kg/m2 (FMD measurements can be inaccurate in severely obese patients).

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): NCT03775382


Locations
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United States, Delaware
Neurovascular Aging Laboratory Recruiting
Newark, Delaware, United States, 19713
Contact: Joshua C Hobson, MS    302-831-8137    chs-novalab@udel.edu   
Contact: Christopher R Martens, PhD    302-831-7270      
Sponsors and Collaborators
University of Delaware
Investigators
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Principal Investigator: Christopher R Martens, Ph.D. University of Delaware

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Responsible Party: Christopher Martens, Assistant Professor, University of Delaware
ClinicalTrials.gov Identifier: NCT03775382     History of Changes
Other Study ID Numbers: Martens - 1138735
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Ascorbic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances