Pharmacodynamics/electroencephalographic (EEG) study with Ginkgo biloba special extract EGb 761®

ISRCTN	ISRCTN50622732
DOI	https://doi.org/10.1186/ISRCTN50622732
Protocol serial number	523001.01.098
Sponsor	Dr. W. Schwabe GmbH & Co. KG (Germany)
Funder	Dr. W. Schwabe GmbH & Co. KG (Germany)

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

Universitätsklinikum Schleswig-Holstein
Campus Lübeck
Klinik für Neurologie
Ratzeburger Alle 160
Lübeck
23538
Germany

Study information

Primary study design	Interventional
Study design	Single-centre open-label single-arm exploratory clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Phase I
Drug / device / biological / vaccine name(s)	Ginkgo biloba special extract EGb 761®
Primary outcome measure(s)	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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	30/09/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	20
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes