Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Total Enrollment
80 participants
Study Classification
OBSERVATIONAL
Study Start Date
2022-07-19
Study Completion Date
2026-07-31
Brief Summary
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Brain blood flow regulation will be measured in response to environmental changes using MRI.
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Detailed Description
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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.
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.
Conditions
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Brain Blood Flow
Healthy
Study Design
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Observational Model Type
CASE_CONTROL
Study Time Perspective
PROSPECTIVE
Study Groups
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Controls
Healthy controls
MRI
Intervention Type
DEVICE
Participants will undergo an MRI scan while participating in two breathing tests (hypercapnia and hypoxia) to measure brain blood flow.
Vertebral Artery Hypoplasia
Healthy individuals with vertebral artery hypoplasia
MRI
Intervention Type
DEVICE
Participants will undergo an MRI scan while participating in two breathing tests (hypercapnia and hypoxia) to measure brain blood flow.
Interventions
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MRI
Participants will undergo an MRI scan while participating in two breathing tests (hypercapnia and hypoxia) to measure brain blood flow.
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* BMI ≤38.5 kg/m2
* Nonsmoker
* Female subjects: postmenopausal
* Currently enrolled in the Wisconsin Alzheimer's Disease Research Clinical Core
* 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
* 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
Minimum Eligible Age
55 Years
Maximum Eligible Age
69 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Sponsor Role
collaborator
University of Wisconsin, Madison
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jill N Barnes, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin-Madison
Madison, Wisconsin, United States
Site Status
Countries
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United States
References
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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.
Reference Type
BACKGROUND
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.
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BACKGROUND
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.
Reference Type
BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Alwatban M, Murman DL, Bashford G. Cerebrovascular Reactivity Impairment in Preclinical Alzheimer's Disease. J Neuroimaging. 2019 Jul;29(4):493-498. doi: 10.1111/jon.12606. Epub 2019 Feb 12.
Reference Type
BACKGROUND
Moskowitz MA, Lo EH, Iadecola C. The science of stroke: mechanisms in search of treatments. Neuron. 2010 Jul 29;67(2):181-98. doi: 10.1016/j.neuron.2010.07.002.
Reference Type
BACKGROUND
Wong SM, Jansen JFA, Zhang CE, Hoff EI, Staals J, van Oostenbrugge RJ, Backes WH. Blood-brain barrier impairment and hypoperfusion are linked in cerebral small vessel disease. Neurology. 2019 Apr 9;92(15):e1669-e1677. doi: 10.1212/WNL.0000000000007263. Epub 2019 Mar 13.
Reference Type
BACKGROUND
Peng SL, Chen X, Li Y, Rodrigue KM, Park DC, Lu H. Age-related changes in cerebrovascular reactivity and their relationship to cognition: A four-year longitudinal study. Neuroimage. 2018 Jul 1;174:257-262. doi: 10.1016/j.neuroimage.2018.03.033. Epub 2018 Mar 19.
Reference Type
BACKGROUND
Miller KB, Howery AJ, Rivera-Rivera LA, Johnson SC, Rowley HA, Wieben O, Barnes JN. Age-Related Reductions in Cerebrovascular Reactivity Using 4D Flow MRI. Front Aging Neurosci. 2019 Oct 17;11:281. doi: 10.3389/fnagi.2019.00281. eCollection 2019.
Reference Type
BACKGROUND
Iqbal S. A comprehensive study of the anatomical variations of the circle of willis in adult human brains. J Clin Diagn Res. 2013 Nov;7(11):2423-7. doi: 10.7860/JCDR/2013/6580.3563. Epub 2013 Nov 10.
Reference Type
BACKGROUND
Hays CC, Zlatar ZZ, Wierenga CE. The Utility of Cerebral Blood Flow as a Biomarker of Preclinical Alzheimer's Disease. Cell Mol Neurobiol. 2016 Mar;36(2):167-79. doi: 10.1007/s10571-015-0261-z. Epub 2016 Feb 22.
Reference Type
BACKGROUND
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Reference Type
BACKGROUND
Slessarev M, Han J, Mardimae A, Prisman E, Preiss D, Volgyesi G, Ansel C, Duffin J, Fisher JA. Prospective targeting and control of end-tidal CO2 and O2 concentrations. J Physiol. 2007 Jun 15;581(Pt 3):1207-19. doi: 10.1113/jphysiol.2007.129395. Epub 2007 Apr 19.
Reference Type
BACKGROUND
Poublanc J, Sobczyk O, Shafi R, Sayin ES, Schulman J, Duffin J, Uludag K, Wood JC, Vu C, Dharmakumar R, Fisher JA, Mikulis DJ. Perfusion MRI using endogenous deoxyhemoglobin as a contrast agent: Preliminary data. Magn Reson Med. 2021 Dec;86(6):3012-3021. doi: 10.1002/mrm.28974. Epub 2021 Oct 22.
Reference Type
BACKGROUND
Mikhail Kellawan J, Harrell JW, Roldan-Alzate A, Wieben O, Schrage WG. Regional hypoxic cerebral vasodilation facilitated by diameter changes primarily in anterior versus posterior circulation. J Cereb Blood Flow Metab. 2017 Jun;37(6):2025-2034. doi: 10.1177/0271678X16659497. Epub 2016 Jan 1.
Reference Type
BACKGROUND
Barton GP, Corrado PA, Francois CJ, Chesler NC, Eldridge MW, Wieben O, Goss KN. Exaggerated Cardiac Contractile Response to Hypoxia in Adults Born Preterm. J Clin Med. 2021 Mar 10;10(6):1166. doi: 10.3390/jcm10061166.
Reference Type
BACKGROUND
Mardimae A, Balaban DY, Machina MA, Battisti-Charbonney A, Han JS, Katznelson R, Minkovich LL, Fedorko L, Murphy PM, Wasowicz M, Naughton F, Meineri M, Fisher JA, Duffin J. The interaction of carbon dioxide and hypoxia in the control of cerebral blood flow. Pflugers Arch. 2012 Oct;464(4):345-51. doi: 10.1007/s00424-012-1148-1. Epub 2012 Sep 9.
Reference Type
BACKGROUND
Miller KB, Howery AJ, Harvey RE, Eldridge MW, Barnes JN. Cerebrovascular Reactivity and Central Arterial Stiffness in Habitually Exercising Healthy Adults. Front Physiol. 2018 Aug 17;9:1096. doi: 10.3389/fphys.2018.01096. eCollection 2018.
Reference Type
BACKGROUND
Barnes JN, Harvey RE, Eisenmann NA, Miller KB, Johnson MC, Kruse SM, Lahr BD, Joyner MJ, Miller VM. Cerebrovascular reactivity after cessation of menopausal hormone treatment. Climacteric. 2019 Apr;22(2):182-189. doi: 10.1080/13697137.2018.1538340. Epub 2019 Jan 21.
Reference Type
BACKGROUND
Ahmed M, Giesbrecht GG, Serrette C, Georgopoulos D, Anthonisen NR. Ventilatory response to hypoxia in elderly humans. Respir Physiol. 1991 Mar;83(3):343-51. doi: 10.1016/0034-5687(91)90053-l.
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BACKGROUND
Vovk A, Smith WD, Paterson ND, Cunningham DA, Paterson DH. Peripheral chemoreceptor control of ventilation following sustained hypoxia in young and older adult humans. Exp Physiol. 2004 Nov;89(6):647-56. doi: 10.1113/expphysiol.2004.027532. Epub 2004 Jul 15.
Reference Type
BACKGROUND
Other Identifiers
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Protocol Version 4/6/2022
Identifier Type: OTHER
Identifier Source: secondary_id
A176000
Identifier Type: OTHER
Identifier Source: secondary_id
2020-0423
Identifier Type: -
Identifier Source: org_study_id
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