Mild Mental Impairment
Conditions
Interventions
Product Name: EGb® 761 240 mg SF, film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Extractum siccum Ginkgo biloba
Current Sponsor code: EGb 761
Other descriptive name:
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible for inclusion in this study, if they fulfil all of the following criteria: 1. Male or female outpatients aged 45 to 65 years (both inclusive) 2. Suffering from mild mental impairment as defined by the diagnostic criteria outlined under section 8.7 in clinical trial protocol: a) subjective complaints of impairment – perceived as a decline from former level of functioning – in at least one of the following cognitive functions: memory, attention/concentration, speed of functioning, efforts required to complete complex tasks, general performance/efficiency b) presence of at least one of the following neuropsychiatric symptoms: depressed mood/dysphoria, anxiety, irritability/lability, apathy/indifference, fatigue, decreased general wellbeing c) perceived impairment present for at least 3 months d) widely preserved general cognitive functioning, as evidenced by a total score above 23 in the MMSE e) intact activities of daily living, as evidenced by inquiry (subtle difficulties, in particular slowing or increased efforts, in complex tasks is acceptable) f) no indication of dementia 3. Written informed consent according to applicable law 4. Sufficient estonian language skills to understand and respond to all interview questions and undergo neuropsychological testing without evident difficulties and without the assistance of an interpreter Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with any of the following characteristics must not be included in the study: 1. Participation in another experimental drug trial at the same time or within the past 4 weeks before enrolment 2. Prior participation in a clinical trial with Ginkgo biloba within the last 3 months 3. Hospitalization of the patient 4. Ischaemic stroke with sequelae within the last 3 months 5. Cognitive impairment due to systemic or cerebral infection, somatic disorders, neurological disorders (e.g. dementia of any type, alcohol-associated brain damage, HIV-associated cognitive disorder, Parkinson’s disease, Huntington’s disease, Pick’s disease, Wilson’s disease, normal pressure hydrocephalus, progressive supranuclear palsy, Creutzfeldt-Jakob disease, brain tumour, subdural haematoma, multiple sclerosis, seizure disorder, brain trauma, etc) or psychiatric disorder (e.g. affective or anxiety disorder on a syndromal level), including clinical suspicion of any of the above. 6. History of recurrent major depression or recurrent anxiety disorder. If a single episode of such a disorder was present before, it must have been finished at least one year before enrolment. 7. D-S’ item score for item 11 (suicidal ideation) > 0 8. History of head trauma that might be causally related to cognitive impairment because of: - its clinical severity or - trauma-related lesions in CT or - temporal relationship to the onset of cognitive dysfunction or - repeated minor head trauma 9. Any use of antidementia drugs, nootropics, cognition enhancing drugs, CNS stimulants, cholinergic and anticholinergic drugs unless there is an at least 8-week washout before entering the randomised treatment period (for details see Section 6 in clinical trial protocol) 10. Any continued use of psychoactive drugs, such as antidepressants, neuroleptics, tranquilizers, sedatives, hypnotics, sedating anti-histamine agents, sedating analgesic drugs. Occasional use (up to three times a week) of tranquilizers for sleep disturbances is permissible, but not within 48 hours prior to test sessions (for details see Section 6 in clinical trial protocol) 11. Any use of haemorrheologic drugs, anti-epileptics and anti Parkinson drugs unless there is a washout of at least 8 weeks before entering the randomised treatment period (for details see Section 6 in clinical trial protocol) 12. Substance addiction or abuse within the last 5 years 13. Severe, uncontrolled cardiovascular disease, especially: - severe (stage IV acc. to Canadian Cardiovascular Society) or unstable angina pectoris - decompensated congestive heart failure (NYHA stage IV) - myocardial infarction within the last 6 months - uncontrolled hypertension (systolic pressure > 180mmHg, diastolic pressure > 115mmHg) - known clinically significant cardiac arrhythmias (Lown classes IVb and V) 14. Severe renal or hepatic dysfunction (serum creatinine or serum ASAT, ALAT or Gamma-GT above 3 times the upper limit of the reference range) 15. Insufficiently controlled insulin-dependent diabetes mellitus 16. Clinically significant anaemia 17. Known clinically significant thyroid dysfunction 18. Known HIV infection or Lues of any stage (according to medical history or clinical signs and symptoms) 19. Active malignant disease (Exception: prostate cancer T1N0M0 which does not require treatment within the next 7 months except hormone therapy) 20. Known hypersensitivity to Ginkgo biloba extract 21. Severe and insuf
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this clinical trial is to prove the clinical efficacy, safety and tolerability of the Ginkgo biloba special extract EGb 761 in mild mental impairment (MMI). Since both complaints of cognitive decline and associated neuropsychiatric symptoms are core features of the condition and contribute substantially to patients' distress and impaired quality of life, efficacy assessment will include both perceived cognitive function and neuropsychiatric symptoms. Clinical efficacy is expected to manifest itself as an improvement, compared with the placebo group, in the perceived cognitive impairment and/or in the neuropsychiatric symptoms in the patient group tested with EGB 761. ;Secondary Objective: ;Primary end point(s): Cognitive Domain: Perceived changes in the following two of five assessed capabilities of the cognitive domain, self-assessed at week 12 by the patient on a 7-point scale using the "Questionnaire of cognitive functions": - memory - attention / concentration Neuropsychiatric Domain: Perceived changes in the following two of six assessed conditions of the neuropsychiatric domain, self-assessed at week 12 by the patient on a 7-point scale using the "Questionnaire of neuropsychiatric symptoms": - depressed mood / dysphoria - anxiety | — |
Countries
Estonia
Outcome results
None listed