Healthy volunteers
Conditions
Interventions
Group 1: EGb 761 240 mg/d
Group 2: Placebo
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
50 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and female volunteers = 50 and = 65 years of age 2. Written informed consent 3. Normal routine laboratory values of hematology and clinical chemistry 4. Average or slightly below average cognitive performance in psychometric testing 5. Female volunteers with childbearing potential must use effective means of contraception 6. Willingness and ability to comply with all protocol-specified procedures
Exclusion criteria
Exclusion criteria: 1. Depression that required any antidepressive drug treatment within the last 12 months before study treatment and/or BDI-II score of = 18 2. Psychotherapeutic or psychiatric treatment within the last 12 months before study treatment 3. Diabetes mellitus or other known other endocrine diseases (exception: adaequately treated thyroid hypo- or hyperfunction) 4. Cerebrovascular diseases including stroke, Alzheimer’s disease or other dementia, other neurological diseases such as multiple sclerosis, seizure disorders, cardiovascular disease or history of myocardial infarction, renal insufficiency or other chronic diseases 5. Any previous or concurrent malignancy or any cancer unless curatively treated > 3 years prior to study entry except cervical carcinoma in situ or adequately treated basal cell carcinoma 6. Hemorrhagic diathesis 7. Planned surgical intervention or hospital admission within the next six months 8. Any condition, including the presence of clinically relevant laboratory or ECG abnormalities or abnormalities at physical examination, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study 9. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from giving informed consent 10. Intake of any preparation containing Ginkgo biloba within the last eight weeks 11. Concomitant medication affecting central nervous system 12. Cardiac pacemaker, cochlea implants or other implanted metal devices, residual metal splinters 13. Marked claustrophobia 14. Smokers with a consumption of > 15 cigarettes per day 15. Hypersensitivity against Ginkgo biloba dry extract or any of the other constituents of study medication (including lactose intolerance) 16. Any antithrombotic treatment within the last four weeks or still ongoing 17. Pregnant or lactating women 18. Participation in a further clinical trial with experimental drug or experimental therapy at the same time or within the past 4 weeks 19. Gastrointestinal disorders with uncertain absorption of orally administered drugs (e.g. partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, other disorders associated with chronic diarrhoea) 20. Insufficient German language skills
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| none | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of behavioral performance in experimental cognitive paradigms assessing different components of cognitive control. Change of neural activation (indicated by BOLD signal in fMRI) during cognitive tasks in lateral, medial, and anterior regions of the prefrontal cortex, the striatum, and other brain regions including the parietal and temporal cortex. Change of level of cortisol in saliva as marker of hypothalamus-pituitary-adrenal axis activity (HPA) in the experimental Trier Social Stress Test setting. | — |
Countries
Germany
Contacts
Public ContactChristoph Schindler
Institut für Klinische Pharmakologie, Technische Universität Dresden
Outcome results
None listed