Non-erythroid Effects of Erythropoietin on Cognitive Function and Exercise Capacity in Humans

Phase 1

• Conditions: Healthy
• Interventions: Drug: Erythropoietin (Epoetin beta); Drug: Placebo

• Registration Number: NCT01889056
• Lead Sponsor: University of Zurich

Brief Summary

The blood hormone Erythropoietin (Epo) is not only produced by the kidneys but also by the brain, especially under hypoxic conditions. It has been shown in animal studies and human studies that Epo has neuroprotective properties. Furthermore, there is scientific evidence for central modulatory effects of Epo in the brain but high dose of Epo is needed to overcome the blood brain barrier. In a double blind placebo controlled crossover study we will investigate the effects of a single high dose of Epo on cognitive function and exercise capacity in healthy subjects. The subjects will receive a single high dose of Epo (60.000 IU) and will perform a computerized cognitive test battery, a breathing test, a maximal exercise capacity test (VO2max), and a time trial (TT) 24 hours after the treatment. The primary outcome of the study will be the cognitive function.

* Trial with medicinal product

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-26
• Status Verified: 2013-06
• Study First Submitted QC: 2013-06-25
• Last Update Submitted: 2013-06-25
• Study First Posted: 2013-06-28
• Last Update Posted: 2013-06-28
• Primary Completion: 2013-09
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Erythropoietin (Epoetin beta)	Erythropoietin (Epoetin beta)	Short infusion of 60.000 IU Epoetin beta in 0.9% sodium chloride solution (250 ml)
0.9% sodium chloride solution	Placebo	Short infusion of 0.9% sodium chloride solution (250 ml)

Primary Outcome Measures

Name	Time	Method
Cognitive Function	1 year	The following parameters of cognitive function will be tested via computer-based cognitive testing (Units: Scores, Percent Correct, Response time): * Working memory capacity; * Executive function; * Processing speed

Secondary Outcome Measures

Name	Time	Method
Exercise Capacity	1 year	Evaluation of exercise capacity via specific exercise tests: * VO2max test; * 20-minutes time trial (TT)

Trial Locations

Locations (1)

University Hospital Zurich, Medical intensive care unit; 🇨🇭 Zurich, ZH, Switzerland