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Active, Not Recruiting

NCT Number: NCT05396287

Blood Vessel Anatomy and Blood Flow Regulation

Brain blood flow regulation will be measured in response to environmental changes using MRI.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

55 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin-Madison

Madison, Wisconsin, 53706, United States

About this study

Global brain blood flow decreases with advancing age; however, some adults have accelerated declines in brain blood flow, placing them at a greater risk of cognitive impairment. Similarly, brain reactivity to increased levels of carbon dioxide decreases with age, with a greater decline in adults with vascular risk factors and is impaired in early Alzheimer's disease. Preclinical models suggest that reduced brain blood flow, results in low levels of oxygen regionally. Currently, there are a lack of human studies that investigate the cause or consequence of altered blood flow regulation in the brain.

The research aims are:

  • Determine the impact of vertebral artery hypoplasia (VAH) on brain reactivity to increased levels of carbon dioxide.
  • Determine the impact of VAH on the brain blood flow response to acute low levels of oxygen.

Who can participate

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

Inclusion criteria

  • BMI ≤38.5 kg/m2
  • Nonsmoker
  • Female subjects: postmenopausal
  • Currently enrolled in the Wisconsin Alzheimer's Disease Research Clinical Core

Exclusion criteria

  • Diagnosis of mild cognitive impairment or Alzheimer's disease
  • Uncontrolled hypertension
  • History or evidence of hepatic disease, hematological disease, or peripheral vascular disease
  • Severe kidney injury requiring hemodialysis
  • Cardiovascular disease including: severe congestive heart failure, coronary artery disease, ischemic heart disease (stents, coronary artery bypass grafts) and tachycardia
  • History of clinically significant ischemic or hemorrhagic stroke, or significant cerebrovascular disease
  • History of HIV/AIDS
  • Severe untreated obstructive sleep apnea
  • History of diabetes with HbA1c greater than 9.5%
  • Major neurologic disorders other than dementia (e.g., multiple sclerosis, amyotrophic lateral sclerosis, brain surgery, etc.)
  • Current or recent (<1 year) major psychiatric condition (Axis I) or addictive disorders
  • Contraindications to MRI

Treatment and study plan

MRI

Device

Participants will undergo an MRI scan while participating in two breathing tests (hypercapnia and hypoxia) to measure brain blood flow.

Primary outcomes

  1. Cerebral Vascular Reactivity to Hypercapnia

    Time frame: One study visit, up to 120 minutes in the MRI

    The change in brain blood flow using MRI will be measured in response to a hypercapnic breathing test. The participants cerebral vascular reactivity to hypercapnia will be compared between the controls (without VAH) and those with VAH.

  2. Cerebral Blood Flow Response to Hypoxia

    Time frame: One study visit, up to 120 minutes in the MRI

    The change in brain blood flow using MRI will be measured in response to a hypoxic breathing test. The participants cerebral blood flow response to hypoxia will be compared between the controls (without VAH) and those with VAH.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

The Impact of Cerebral Anatomical Variations on Cerebrovascular Reactivity

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 31, 2022
Registry last updated
Jul 7, 2026

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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