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

NCT01889056 | Unknown Phase 1

• 1 other identifier: EPOPERF CH12
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

Erythropoietin; Cognition; Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Exercise Capacity

  1 year

Other Outcomes (1)

• Subjective Well-Being

  1 year

Study Arms (2)

Erythropoietin (Epoetin beta)

EXPERIMENTAL

Short infusion of 60.000 IU Epoetin beta in 0.9% sodium chloride solution (250 ml)

Drug: Erythropoietin (Epoetin beta)

0.9% sodium chloride solution

PLACEBO COMPARATOR

Short infusion of 0.9% sodium chloride solution (250 ml)

Drug: Placebo

Interventions

Erythropoietin (Epoetin beta) DRUG

Also known as: Recormon

Erythropoietin (Epoetin beta)

Placebo DRUG

0.9% sodium chloride solution

0.9% sodium chloride solution

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Medical intensive care unit

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Erythropoietin; epoetin beta

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Marco Maggiorini, Prof MD

  University Hospital Zurich, Medical intensive care unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: June 28, 2013
• Study Start: February 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 28, 2013

Record last verified: 2013-06

Locations

CH (1)