Non-erythroid Effects of Erythropoietin on Cognitive Function and Exercise Capacity in Humans
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- University of Zurich
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Cognitive Function
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
0.9% sodium chloride solution
Short infusion of 0.9% sodium chloride solution (250 ml)
Intervention: Placebo (Drug)
Erythropoietin (Epoetin beta)
Short infusion of 60.000 IU Epoetin beta in 0.9% sodium chloride solution (250 ml)
Intervention: Erythropoietin (Epoetin beta) (Drug)
Outcomes
Primary Outcomes
Cognitive Function
Time Frame: 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 Outcomes
- Exercise Capacity(1 year)