What side effects are associated with this type of intervention?

Common treatments for stroke that involve antioxidants or pro-oxidant agents, such as oxygen radical scavengers, aim to mitigate oxidative stress and improve cerebral blood flow. Known side effects of these treatments can include gastrointestinal disturbances, allergic reactions, and potential interactions with other medications. Additionally, some antioxidants may cause pro-oxidant effects at high doses, leading to cellular damage. It is crucial to monitor patients closely to balance the therapeutic benefits with potential adverse effects.

What prior FDA approvals exist?

FDA-approved treatments for stroke primarily include thrombolytics like alteplase (tPA), which dissolves blood clots, and mechanical thrombectomy devices for clot removal. While there are no specific FDA-approved treatments for stroke that directly modulate reactive oxygen species, research is ongoing in this area. Antioxidants and agents affecting ROS are being studied for their potential to protect brain tissue and improve outcomes in stroke patients.

What other types of research exist?

Promising novel alternatives for stroke treatment in 2024 include neuroprotective agents like NA-1 (nerinetide), which targets excitotoxicity, and anti-inflammatory agents such as IL-1 receptor antagonists. Additionally, stem cell therapy and advanced thrombolytic agents like tenecteplase are being explored for their potential to improve outcomes in stroke patients.

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Antioxidant Cocktail for Stroke Prevention

N/A

Recruiting

Led By William G Schrage, PhD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between ≥18 - ≤40 years

Be between 18 and 65 years old

Must not have

Current diagnosis or history of sleep apnea

Current diagnosis or history of diabetes mellitus (type 1, type 2, MODY, or others)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Summary

This trial tests a special mix of vitamins to see how it affects brain blood flow in healthy young adults. Researchers want to know if men and women respond differently to high oxygen levels.

Who is the study for?

Healthy adults aged 18-40 can join this study on reactive oxygen species and brain blood flow. Excluded are those with high blood pressure, glucose levels, or a history of heart, liver, kidney diseases; smokers; certain medication users; MRI contraindications; women with irregular menstrual cycles or using hormonal birth control (except copper IUDs).

What is being tested?

The trial is testing an antioxidant cocktail against a placebo in 30 healthy participants to understand its effect on cerebral blood flow. The study spans over six months with two visits.

What are the potential side effects?

Since the intervention includes antioxidants which are generally considered safe for most people when used appropriately, side effects might be minimal but could include potential allergic reactions or gastrointestinal discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with sleep apnea.

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I have been diagnosed with diabetes.

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I am a woman with excessive hair growth on my face, chest, or back.

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I have had a heart attack before.

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I have been diagnosed with high blood pressure.

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I am using a levonorgestrel IUD for birth control.

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I have or had liver disease.

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I have had heart surgery in the past or have been diagnosed with a condition requiring it.

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I have or had peripheral vascular disease.

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I have a condition affecting my menstrual cycle.

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My blood pressure is higher than 125/80 mmHg.

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I have or had lung disease.

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I have or had stomach or intestinal problems that caused bleeding.

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I have had a stroke or currently have one.

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I have or had kidney disease.

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I have or had a blood disorder.

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I have been diagnosed with or have a history of prediabetes.

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I have been diagnosed with polycystic ovary syndrome.

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I have or had coronary heart disease.

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I have been diagnosed with or have a history of heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cerebral Blood Flow: Hyperoxia

Cerebral Blood Flow: Normoxia

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Antioxidant CocktailExperimental Treatment1 Intervention

The first dose will be 500 mg vitamin C, 200 IU vitamin E, and 300 mg of alpha lipoic acid 120 minutes before MRI. The second dose will be 500 mg vitamin C, 400 IU vitamin E, and 300 mg of alpha lipoic acid 60 minutes before MRI.

Group II: PlaceboActive Control1 Intervention

Placebo 120 minutes before MRI, followed by another dose of placebo 60 minutes before MRI.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Antioxidant Cocktail

2011

Completed Phase 2

~290

0 / 21Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for stroke often target the reduction of brain damage and the restoration of blood flow. Thrombolytics, such as tissue plasminogen activator (tPA), dissolve blood clots to restore cerebral blood flow. Antioxidant therapies aim to mitigate oxidative stress by neutralizing reactive oxygen species (ROS), which can cause cellular damage during ischemia-reperfusion injury. This is particularly relevant as oxidative stress contributes to neuronal injury and inflammation. By reducing ROS, antioxidants can potentially protect brain tissue and improve outcomes. Understanding these mechanisms is crucial for developing effective treatments and improving recovery in stroke patients.

Clinical and experimental aspects of aneurysmal subarachnoid hemorrhage.Hyperbaric oxygen in the treatment of patients with cerebral stroke, brain trauma, and neurologic disease.Oxidative stress in subarachnoid haemorrhage: significance in acute brain injury and vasospasm.