Effects of Mitochondrial-targeted Antioxidant on Mild Cognitive Impairment (MCI) Patients
NCT ID: NCT03514875
Last Updated: 2023-08-15
Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2019-11-11
2022-07-18
Brief Summary
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Detailed Description
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We will examine how endothelial function and cerebrovascular blood flow changes after consumption of MitoQ. We hope to achieve this through measures of carotid artery blood flow and brachial artery blood flow, using a doppler ultrasound for both, while using flow mediated dilation when measuring the brachial artery. The flow-mediated dilation test is a validated and safe assessment of endothelial function and vascular health. The premise behind the assessment is that endothelium produces autocoids, like nitric oxide, that dilate in response to shear stress. Flow-mediated dilation has been shown to be an effective tool to assess endothelial function in the peripheral and coronary vasculature. This assessment of endothelial health can be used in healthy individuals to detect risk for cardiovascular disease. We will also utilize near infrared spectroscopy to measure tissue oxygenation in the brain, which is also a measure of improved blood flow, and will measure brain neural activity with an EEG. Finally, we will collect blood samples to measure the change in ROS levels before and after MitoQ consumption
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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MitoQ-Placebo
Subjects will be tested on two different days, first day will be baseline and MitoQ intake, and second day will be placebo intake. Testing will take place 40-minutes after MitoQ and placebo intake. There will be a 2-week washout between testing days.
MitoQ
MitoQ is a mitochondria-targeting antioxidant, which should improve NO bioavailability, and therefore vasodilation
Placebo
A placebo will be used in a double blinded, randomized, cross-over design
Placebo-MitoQ
Subjects will be tested on two different days, first day will be baseline and placebo intake, and second day will be MitoQ intake. Testing will take place 40-minutes after placebo and MitoQ intake. There will be a 2-week washout between testing days.
MitoQ
MitoQ is a mitochondria-targeting antioxidant, which should improve NO bioavailability, and therefore vasodilation
Placebo
A placebo will be used in a double blinded, randomized, cross-over design
Interventions
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MitoQ
MitoQ is a mitochondria-targeting antioxidant, which should improve NO bioavailability, and therefore vasodilation
Placebo
A placebo will be used in a double blinded, randomized, cross-over design
Eligibility Criteria
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Inclusion Criteria
2. Have a clinical diagnosis of Mild Cognitive Impairment (MCI) verified by a medical doctor
3. have a stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks.
4. Free of kidney, metabolic or cardiovascular disease, including hypertension (stage 2) and previous cardiac events
5. be between 50-85 years old
Exclusion Criteria
2. Not be taking prescription drugs (other than oral contraceptives, blood pressure lowering drugs, and metformin)
3. Must not be diagnosed with Alzheimer's disease.
50 Years
85 Years
ALL
No
Sponsors
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University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Song-young Park, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska
References
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Kelleher RJ, Soiza RL. Evidence of endothelial dysfunction in the development of Alzheimer's disease: Is Alzheimer's a vascular disorder? Am J Cardiovasc Dis. 2013 Nov 1;3(4):197-226.
Luchsinger JA, Reitz C, Honig LS, Tang MX, Shea S, Mayeux R. Aggregation of vascular risk factors and risk of incident Alzheimer disease. Neurology. 2005 Aug 23;65(4):545-51. doi: 10.1212/01.wnl.0000172914.08967.dc.
Green DJ, Jones H, Thijssen D, Cable NT, Atkinson G. Flow-mediated dilation and cardiovascular event prediction: does nitric oxide matter? Hypertension. 2011 Mar;57(3):363-9. doi: 10.1161/HYPERTENSIONAHA.110.167015. Epub 2011 Jan 24.
Green DJ, Dawson EA, Groenewoud HM, Jones H, Thijssen DH. Is flow-mediated dilation nitric oxide mediated?: A meta-analysis. Hypertension. 2014 Feb;63(2):376-82. doi: 10.1161/HYPERTENSIONAHA.113.02044. Epub 2013 Nov 25.
Other Identifiers
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0088-18-FB
Identifier Type: -
Identifier Source: org_study_id
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