Randomised, Double-Blind, Placebo-Controlled, Parallel Group Trial to Confirm the Efficacy, Safety and Tolerability of Ginkgo biloba Special Extract EGb 761® in Patients Suffering from Mild Mental Impairment (MMI)
- Conditions
- mild mental impairmentClassification code 10027374
- Registration Number
- EUCTR2005-003747-31-LV
- Lead Sponsor
- Dr. Willmar Schwabe GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 300
1. Male or female outpatients aged 45 to 65 years (both inclusive)
2. Suffering from mild mental impairment as defined by the diagnostic criteria:
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) low functioning (at least one standard deviation worse than the mean of the most appropriate normative group) in at least one of the cognitive tests administered at screening and baseline
c) perceived impairment present for at least 3 months
d) widely preserved general cognitive function, 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 Latvian 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
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. Ischemic 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. 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
8. 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 randomized treatment period (for details see Section 6)
9. 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)
10. Any use of haemorrheologic drugs, anti-epileptics and anti Parkinson drugs unless there is a washout of at least 8 weeks before entering the randomized treatment period (for details see Section 6)
11. Substance addiction or abuse within the last 5 years
12. 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)
13.Severe renal or hepatic dysfunction (serum creatinine or serum ASAT, ALAT or Gamma-GT above 3 times the upper limit of the reference range)
14. Insufficiently controlled insulin-dependent diabetes mellitus
15. Clinically significant anaemia
16. Known clinically significant thyroid dysfunction
17. Known HIV infection or Lues of any stage (according to medical history or clinical signs and symptoms)
18. Active malignant disease (Exception: prostate cancer T1N0M0 which does not require treatment within the next 7 months except hormone therapy)
19.Known hypersensitivity to Ginkgo biloba extract
20.Severe and insufficiently corrected loss of vision or hearing, severe language difficulties or any other disability that may prevent the patient from co-operating adequately in the trial or that may interfere with neuropsychological tes
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method