Effects of Ginkgo biloba extract (EGb 761®) on cognitive control functions, mental activity of the prefrontal cortex and stress reactivity in adult healthy volunteers
- Conditions
- Healthy volunteers
- Registration Number
- DRKS00000423
- Lead Sponsor
- Dr. Willmar Schwabe GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 75
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method none
- Secondary Outcome Measures
Name Time Method Change of behavioral performance in experimental cognitive paradigms assessing<br>different components of cognitive control.<br><br>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.<br><br>Change of level of cortisol in saliva as marker of hypothalamus-pituitary-adrenal axis activity (HPA) in the experimental Trier Social Stress Test setting.<br>