Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
523001.01.098
Study information
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
Acronym
Study hypothesis
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
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
Study design
Single-centre open-label single-arm exploratory clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Ginkgo biloba special extract EGb 761®
Primary outcome measures
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 trial start date
15/03/2011
Overall trial end date
30/09/2011
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20 subjects
Participant 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
Recruitment start date
15/03/2011
Recruitment end date
30/09/2011
Locations
Countries of recruitment
Germany
Trial participating centre
Universitätsklinikum Schleswig-Holstein
Lübeck
23538
Germany
Funders
Funder type
Industry
Funder name
Dr. W. Schwabe GmbH & Co. KG (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary