Effects of Mitochondrial-targeted Antioxidant on Mild Cognitive Impairment (MCI) Patients

NCT03514875 | Withdrawn

• 1 other identifier: 0088-18-FB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Neurodegenerative diseases such as Mild Cognitive Impairment, Alzheimer's, and dementia affect millions of Americans. Although these diseases are heavily researched, there is very little research examining the impact of attenuated carotid artery endothelial function and cerebrovascular blood flow on cognitive function. This is surprising, as cerebrovascular oxygenation has been shown to be strongly associated with reduced cognitive function and the pathogenesis of neurodegenerative diseases. For example, hypertension, diabetes, and high cholesterol have been shown to increase the risk of Alzheimers related dementia. Therefore, the purpose of this proposed study will be to examine the effects of MitoQ supplementation on carotid artery vasodilatory function and cerebrovascular blood flow in those suffering from Mild Cognitive Impairment (MCI). MitoQ is a mitochondria-targeting antioxidant that can improve nitric oxide production in the blood vessel, which should improve endothelial function, and thus cerebrovascular blood flow.

Conditions

Alzheimer Disease, Early Onset; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Carotid artery blood flow

  Blood flow in the carotid artery will be measured with ultrasound

  2 Days

Secondary Outcomes (4)

• Oxidative Stress

  2 days

• Cerebrovascular Oxygenation

  2 Days

• Brain Electrical Activity

  2 Days

• Endothelial Function

  2 Days

Study Arms (2)

MitoQ-Placebo

EXPERIMENTAL

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.

Dietary Supplement: MitoQ; Dietary Supplement: Placebo

Placebo-MitoQ

EXPERIMENTAL

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.

Dietary Supplement: MitoQ; Dietary Supplement: Placebo

Interventions

MitoQ DIETARY_SUPPLEMENT

MitoQ is a mitochondria-targeting antioxidant, which should improve NO bioavailability, and therefore vasodilation

MitoQ-Placebo; Placebo-MitoQ

Placebo DIETARY_SUPPLEMENT

A placebo will be used in a double blinded, randomized, cross-over design

MitoQ-Placebo; Placebo-MitoQ

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be able to give written, informed consent
• Have a clinical diagnosis of Mild Cognitive Impairment (MCI) verified by a medical doctor
• have a stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks.
• Free of kidney, metabolic or cardiovascular disease, including hypertension (stage 2) and previous cardiac events
• be between 50-85 years old

You may not qualify if:

• All participants must be free from smoking and alcohol abuse
• Not be taking prescription drugs (other than oral contraceptives, blood pressure lowering drugs, and metformin)
• Must not be diagnosed with Alzheimer's disease.

Sponsors & Collaborators

• University of Nebraska: lead

Related Publications (4)

• 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.

  PMID: 24224133 BACKGROUND

• 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.

  PMID: 16116114 BACKGROUND

• 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.

  PMID: 21263128 BACKGROUND

• 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.

  PMID: 24277765 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

mitoquinone

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Song-young Park, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 Randomized, cross-over design

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 2, 2018
• Study Start: November 11, 2019
• Primary Completion: July 18, 2022
• Study Completion: July 18, 2022
• Last Updated: August 15, 2023

Record last verified: 2023-08