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OpenTrials
Completed

NCT Number: NCT03775382

Mechanisms of Impaired Brain Blood Flow With Aging

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.

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Key information

Conditions

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurovascular Aging Laboratory

Newark, Delaware, 19713, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Ascorbic acid

Other

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 names: Vitamin C

Normal Saline

Other

Normal saline will be infused by the research nurse into an antecubital vein using an IV infusion pump.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 13, 2018
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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