Cerebrovascular Insufficiency, Mild Cognitive Impairment
Conditions
Keywords
ginkgo biloba, cerebrovascular insufficiency, mild cognitive impairment, concentration impairment
Brief summary
The purpose of the study is to determine weather Ginkgo biloba standardized extract (24% ginkoflavonoglicozides and 6% terpenes) is effective in treatment of cognitive and concentration impairment
Detailed description
Inclusion criteria is cerebrovascular insufficiency MNSE\>20. 90 patients are divided into three groups randomly. First group is being administered 120 mg ginkgo biloba extract, second group 60 mg of the extract and the third group has being administered placebo during the period of 6 months. Methods used for evaluation are SCAG, MMSE, MDRS, VFT, CGI, TCD and color Doppler of carotid arteries. Methods used for follow up safety include: routine blood tests, biochemical tests, neurologic and physical examination, vital signs and ECG.
Interventions
tablets, 120 mg/day (60 mg two times daily) during 6 months
tablets, 60 mg/day during 6 months
placebo during 6 months
Sponsors
Study design
Eligibility
Inclusion criteria
* cerebrovascular insufficiency and mild cognitive disorder (MMSE=20-28)
Exclusion criteria
* pregnancy * cognitive disorder caused by psychological, metabolic endocrine nutritional and heart disorder * alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of MMSE | 6 months |
| Changes of MDRS | 6 months |
| Changes of VFT | 6 months |
| Changes of CGI | 6 months |
| Changes of SCAG | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Changes of platelets, hematocrit, prothrombin time, and activated partial tromboplastin time | 6 months |
| Changes of total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides | 6 months |
| Safety will be assessed according to occurrence of adverse events during the trial | 6 months |
| Changes of TCD, and color Doppler of carotid arteries | 6 months |
Countries
Croatia