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

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

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Erythropoietin (Epoetin beta)

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • University Hospital Zurich, Medical intensive care unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Healthy Subjects;
• Age between 18 to 35 years;
• Normal body weight (body mass index of >= 18.5 kg/m2 <= 24.9 kg/m2);
• Nonsmokers (>= 1 year);
• VO2max of <= 55 ml/kg/min for females and <= 60 ml/kg/min for males;

Exclusion criteria:

• Persons with abnormal Serum Ferritin levels according to gender dependent reference values of GCP-certificated laboratory;
• Persons with pre-existing genetic hemostatic disorders (Factor V Leiden mutation, Prothrombin mutation);
• Persons which are at risk of deep venous thrombosis (e.g. history of venous thromboembolic events);
• Persons with a hematocrit value of > 55%;
• Persons being exposed to prolonged (>= 5 days) high altitude (>= 2500m above Normal Null) <= 6 months prior the beginning of the study;
• Persons not willing to maintain their living conditions during the study period (e.g. preparing for a certain competition);
• Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product;
• Pregnant or breast feeding women;
• Intention to become pregnant during the course of the study;
• Lack of safe contraception;
• Treatment with other investigational products;
• Known or suspected non-compliance, drug or alcohol abuse;
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders;
• Participation in another study with investigational drug within the 30 days preceding and during the present study;
• Enrolment of the investigator, his/her family members, employees and other dependent persons;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erythropoietin (Epoetin beta); Short infusion of 60.000 IU Epoetin beta in 0.9% sodium chloride solution (250 ml)	Drug: Erythropoietin (Epoetin beta); Other Names: Recormon
Placebo Comparator: 0.9% sodium chloride solution; Short infusion of 0.9% sodium chloride solution (250 ml)	Drug: Placebo; 0.9% sodium chloride solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Function	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Capacity	Evaluation of exercise capacity via specific exercise tests: VO2max test; 20-minutes time trial (TT)	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Well-Being	Evaluation of subjective well-being via: Questionnaires; Visual Analog Scales	1 year

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Marco Maggiorini, Prof MD, University Hospital Zurich, Medical intensive care unit

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: February 26, 2013
• First Submitted That Met QC Criteria: June 25, 2013
• First Posted (Estimate): June 28, 2013

Study Record Updates

• Last Update Posted (Estimate): June 28, 2013
• Last Update Submitted That Met QC Criteria: June 25, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Exercise; Erythropoietin; Cognition
• Additional Relevant MeSH Terms: Hematinics; Epoetin Alfa
• Other Study ID Numbers: EPOPERF CH12