Mild cognitive deficits Mental and Behavioural Disorders Mild cognitive deficits
Conditions
Interventions
Ginkgo biloba EGb 761® 240 mg film-coated tablets
1 tablet/day for 8 weeks
EEG examinations
computer-based cognitive tests
psychological rating scales
Sponsors
Dr. W. Schwabe GmbH & Co. KG (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 45 to 65 years 2. Informed consent according to legal requirements 3. Subject is capable to consent without any limitations 4. Existence of mild cognitive deficits, objectified by 4.1. A percentile below 16 in atleast 2 of 6 test parameters of the cognitive test battery 4.2. Alertness test (response time with/without audio warning) 4.3. Go/NoGo test (response time, mistakes) 4.4. Shared attention test (response time, mistakes) or 4.5 A percentile below 16 in one test parameter of the cognitive test battery and evidence of acquired attention disturbances and executive disturbances, relevant for every day life, i.e. questionnaire of experienced deficits of attention - distractibility and retardation in mental processes, FEDA-AV less than or equal to 45 or FEDA-EV less than or equal to 31 or fatigue and slowdown in practical activities, FEDA-AN less than or equal to 20
Exclusion criteria
Exclusion criteria: 1. Participation in another experimental drug trial at the same time or within the past 4 weeks before enrolment 2. Pregnancy or lactation period (exclusion by pregnancy test for all women of childbearing potential) 3. Women of child-bearing potential, i. e. who do not meet at least one of the following criteria: 3.1.Hormonal contraception for at least 6 months 3.2. Post menopausal status for at least 2 years 3.3. Hysterectomy 3.4. Bilateral oophorectomy 4. Active peptic ulcer disease or any gastrointestinal diseases with potential impairment of the absorption of orally applied drugs (e.g. Billroth I + II, Crohn´s disease, ulcerative colitis, any kind of enterectomy), celiac disease, dietically inadequately controlled lactose intolerance, other diseases causing malabsorption or chronical diarrhoea) 5. Persisting or recurrent neurological or psychiatric disorder at the time of enrolment 6. Severe, medically uncontrolled cardiovascular or pulmonary disease 7. Clinically relevant renal or hepatic dysfunction (serum creatinine or serum ASAT, ALAT or Gamma GT above 3 times the upper limit of the reference range) 8. Other severe metabolic disorders or progressive diseases [e.g. insulin-dependent diabetes mellitus, anaemia, vitamin deficiencies, cancer, known human immunodeficiency virus (HIV) infection/Acquired immunodeficiency syndrome(AIDS), syphilis) 9. Abnormal neurological and/or psychopathological findings 10. Intake of prohibited medications 11. Total score in Mini-Mental-Status < 26 12. Status after apoplexia 13. Status after cranial or brain injury 14. Apraxia (i. e. Morbus Parkinson, Dystonia) 15. Severe and insufficiently corrected loss of vision or hearing, severe language difficulties or any other disability that may prevent the subject from co-operating adequately in the trial or that may interfere with neuropsychological test performance 16. Known hypersensitivity to Ginkgo biloba, Ginkgo biloba extract or any ingredient of the drug under study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cognitive/clinical: error rate, error correction rate, error correction time, post-error slowing, post-non-inhibition slowing, stop signal reaction time in Flanker/Stop exercise; reaction time and electoral behaviour in recompensation exercise; cognitive test battery; Beck Depression Inventory II; FEDA 2. EEG: amplitude of error-related negativity (ERN), amplitude of error positivity, amplitude of correction-related negativity, amplitude of N2 component, amplitude of Stop-ERN, amplitude of Stop-N2 in Flanker-Stop exercise; amplitude of feedback-related negativity (FRN) in the recompensation exercise | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Germany
Outcome results
None listed