Pharmacodynamics/electroencephalographic (EEG) study with Ginkgo biloba special extract EGb 761®
| ISRCTN | ISRCTN50622732 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50622732 |
| Secondary identifying numbers | 523001.01.098 |
- Submission date
- 21/02/2011
- Registration date
- 12/04/2011
- Last edited
- 12/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Thomas Münte
Scientific
Scientific
Universitätsklinikum Schleswig-Holstein
Campus Lübeck
Klinik für Neurologie
Ratzeburger Alle 160
Lübeck
23538
Germany
Study information
| Study design | Single-centre open-label single-arm exploratory clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | An open-label, exploratory clinical trial to investigate the effects of Ginkgo biloba special extract EGb 761® on dopamine-induced executive cognitive functions and their neurophysiological correlation in subjects with mild cognitive deficits |
| Study objectives | Investigation of effects of EGb 761® on executive controlling functions and their correlation in electroencephalographic (EEG) examination in subjects with mild cognitive deficits |
| Ethics approval(s) | Ethics Committee of the Medical Faculty of the University Hospital of Schleswig-Holstein, Campus Lübeck (Ethikkommission der Medizinischen Fakultät der Universitätsklinik Schleswig-Holstein, Campus Lübeck) approved on 19.01.2011, reference number: 10-236 |
| Health condition(s) or problem(s) studied | Mild cognitive deficits |
| Intervention | Ginkgo biloba EGb 761® 240 mg film-coated tablets; 1 tablet/day for 8 weeks EEG examinations; computer-based cognitive tests; psychological rating scales |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Ginkgo biloba special extract EGb 761® |
| Primary outcome measure | 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 outcome measures | No secondary outcome measures |
| Overall study start date | 15/03/2011 |
| Completion date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 subjects |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/03/2011 |
| Date of final enrolment | 30/09/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
Universitätsklinikum Schleswig-Holstein
Lübeck
23538
Germany
23538
Germany
Sponsor information
Dr. W. Schwabe GmbH & Co. KG (Germany)
Industry
Industry
Willmar-Schwabe-Str. 4
Karlsruhe
76227
Germany
"ROR" |
https://ror.org/043rrkc78 |
|---|
Funders
Funder type
Industry
Dr. W. Schwabe GmbH & Co. KG (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
