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Brain Blood FlowNCT05396287

Blood Vessel Anatomy and Blood Flow Regulation

An observational study of Brain Blood Flow and Healthy, run by University of Wisconsin, Madison at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Brain blood flow regulation will be measured in response to environmental changes using MRI. Read more about this study

Who is it for?
Ages 55 to 69 years
Conditions the study is for
Brain Blood Flow, Healthy
What is being tested?
MRI
Type of treatment
Medical device
How many people
80 participants
Where
1 siteUnited States
Study dates
19 Jul 2022to May 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 69 years
  • All sexes
  • Adult, Older adult

Study population: Subjects for this study, will include healthy adults enrolled in the Wisconsin Alzheimer's Disease Research Clinical Core. Both men and women are eligible to participate in this study.

Who may be able to join

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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53706

Other trials in United States

About this study

Official title: The Impact of Cerebral Anatomical Variations on Cerebrovascular Reactivity

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

Read the detailed description

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:

  1. Determine the impact of vertebral artery hypoplasia (VAH) on brain reactivity to increased levels of carbon dioxide.
  2. Determine the impact of VAH on the brain blood flow response to acute low levels of oxygen.
Being tested
MRI
Keywords
MRI, Brain blood flow

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRIDevice

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

Study groups in NCT05396287
Study groupRoleWhat they receive
ControlsHealthy controls
Receives: Device: MRI
Vertebral Artery HypoplasiaHealthy individuals with vertebral artery hypoplasia
Receives: Device: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cerebral Vascular Reactivity to Hypercapnia

    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.

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

  2. Cerebral Blood Flow Response to Hypoxia

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2022
  2. Study start19 Jul 2022
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05396287
Sponsor's protocol ID
2020-0423
Other IDs
1RF1NS117746-01, Protocol Version 4/6/2022, A176000
Status last verified
Jul 2026
First submitted
25 May 2022
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kisler K, Nelson AR, Montagne A, Zlokovic BV. Cerebral blood flow regulation and neurovascular dysfunction in Alzheimer disease. Nat Rev Neurosci. 2017 Jul;18(7):419-434. doi: 10.1038/nrn.2017.48. Epub 2017 May 18.

    PubMed 28515434

  • Switzer AR, Cheema I, McCreary CR, Zwiers A, Charlton A, Alvarez-Veronesi A, Sekhon R, Zerna C, Stafford RB, Frayne R, Goodyear BG, Smith EE. Cerebrovascular reactivity in cerebral amyloid angiopathy, Alzheimer disease, and mild cognitive impairment. Neurology. 2020 Sep 8;95(10):e1333-e1340. doi: 10.1212/WNL.0000000000010201. Epub 2020 Jul 8.

    PubMed 32641520

  • Iadecola C. Neurovascular regulation in the normal brain and in Alzheimer's disease. Nat Rev Neurosci. 2004 May;5(5):347-60. doi: 10.1038/nrn1387. No abstract available.

    PubMed 15100718

  • Scheel P, Puls I, Becker G, Schoning M. Volume reduction in cerebral blood flow in patients with vascular dementia. Lancet. 1999 Dec 18-25;354(9196):2137. doi: 10.1016/S0140-6736(99)04016-7.

    PubMed 10609827

  • Marshall RS, Lazar RM. Pumps, aqueducts, and drought management: vascular physiology in vascular cognitive impairment. Stroke. 2011 Jan;42(1):221-6. doi: 10.1161/STROKEAHA.110.595645. Epub 2010 Dec 9.

    PubMed 21148438

  • Wierenga CE, Hays CC, Zlatar ZZ. Cerebral blood flow measured by arterial spin labeling MRI as a preclinical marker of Alzheimer's disease. J Alzheimers Dis. 2014;42 Suppl 4(Suppl 4):S411-9. doi: 10.3233/JAD-141467.

    PubMed 25159672

  • Park JH, Kim JM, Roh JK. Hypoplastic vertebral artery: frequency and associations with ischaemic stroke territory. J Neurol Neurosurg Psychiatry. 2007 Sep;78(9):954-8. doi: 10.1136/jnnp.2006.105767. Epub 2006 Nov 10.

    PubMed 17098838

  • Thierfelder KM, Baumann AB, Sommer WH, Armbruster M, Opherk C, Janssen H, Reiser MF, Straube A, von Baumgarten L. Vertebral artery hypoplasia: frequency and effect on cerebellar blood flow characteristics. Stroke. 2014 May;45(5):1363-8. doi: 10.1161/STROKEAHA.113.004188. Epub 2014 Apr 3.

    PubMed 24699051

  • Peterson C, Phillips L, Linden A, Hsu W. Vertebral artery hypoplasia: prevalence and reliability of identifying and grading its severity on magnetic resonance imaging scans. J Manipulative Physiol Ther. 2010 Mar-Apr;33(3):207-11. doi: 10.1016/j.jmpt.2010.01.012.

    PubMed 20350674

  • Kulyk C, Voltan C, Simonetto M, Palmieri A, Farina F, Vodret F, Viaro F, Baracchini C. Vertebral artery hypoplasia: an innocent lamb or a disguise? J Neurol. 2018 Oct;265(10):2346-2352. doi: 10.1007/s00415-018-9004-7. Epub 2018 Aug 16.

    PubMed 30116939

  • Chen G, Ward BD, Xie C, Li W, Wu Z, Jones JL, Franczak M, Antuono P, Li SJ. Classification of Alzheimer disease, mild cognitive impairment, and normal cognitive status with large-scale network analysis based on resting-state functional MR imaging. Radiology. 2011 Apr;259(1):213-21. doi: 10.1148/radiol.10100734. Epub 2011 Jan 19.

    PubMed 21248238

  • Bangen KJ, Nation DA, Clark LR, Harmell AL, Wierenga CE, Dev SI, Delano-Wood L, Zlatar ZZ, Salmon DP, Liu TT, Bondi MW. Interactive effects of vascular risk burden and advanced age on cerebral blood flow. Front Aging Neurosci. 2014 Jul 7;6:159. doi: 10.3389/fnagi.2014.00159. eCollection 2014.

    PubMed 25071567

  • Barnes JN, Schmidt JE, Nicholson WT, Joyner MJ. Cyclooxygenase inhibition abolishes age-related differences in cerebral vasodilator responses to hypercapnia. J Appl Physiol (1985). 2012 Jun;112(11):1884-90. doi: 10.1152/japplphysiol.01270.2011. Epub 2012 Mar 22.

    PubMed 22442028

  • Barnes JN, Harvey RE, Miller KB, Jayachandran M, Malterer KR, Lahr BD, Bailey KR, Joyner MJ, Miller VM. Cerebrovascular Reactivity and Vascular Activation in Postmenopausal Women With Histories of Preeclampsia. Hypertension. 2018 Jan;71(1):110-117. doi: 10.1161/HYPERTENSIONAHA.117.10248. Epub 2017 Nov 20.

    PubMed 29158356

  • Tchistiakova E, Crane DE, Mikulis DJ, Anderson ND, Greenwood CE, Black SE, MacIntosh BJ. Vascular risk factor burden correlates with cerebrovascular reactivity but not resting state coactivation in the default mode network. J Magn Reson Imaging. 2015 Nov;42(5):1369-76. doi: 10.1002/jmri.24917. Epub 2015 Apr 17.

    PubMed 25884110

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Blood Flow and Healthy, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cerebral Vascular Reactivity to Hypercapnia (time frame: One study visit, up to 120 minutes in the MRI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05396287, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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