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

Healthy Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01889056
• Other study ID #: EPOPERF CH12
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: February 26, 2013
• Last updated: June 25, 2013
• Start date: February 2013
• Est. completion date: December 2013

Study information

• Verified date: June 2013
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Erythropoietin (Epoetin beta)

• Placebo
0.9% sodium chloride solution

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Medical intensive care unit	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjective Well-Being	Evaluation of subjective well-being via: Questionnaires; Visual Analog Scales	1 year	Yes
Primary	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	No
Secondary	Exercise Capacity	Evaluation of exercise capacity via specific exercise tests: VO2max test; 20-minutes time trial (TT)	1 year	No