Condition category
Mental and Behavioural Disorders
Date applied
21/02/2011
Date assigned
12/04/2011
Last edited
12/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Thomas Münte

ORCID ID

Contact details

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

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

Sponsor information

Organisation

Dr. W. Schwabe GmbH & Co. KG (Germany)

Sponsor details

Willmar-Schwabe-Str. 4
Karlsruhe
76227
Germany

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes