Efficacy and Safety of Ginkgo Biloba Extract in Mild Cognitive Impairment and Cerebrovascular Insufficiency

Study Overview
=================
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.

Official Title
-----------------
Efficacy and Safety of Ginkgo Biloba Standardized Extract (24% Ginkoflavonoglicozides and 6% Terpenes) in Treatment of Mild Cognitive and Concentration Impairment

Conditions
-----------------
Mild Cognitive Impairment, Cerebrovascular Insufficiency

Intervention / Treatment
-----------------
* Drug: Ginkgo biloba standardized extract 24/6
* Drug: Ginkgo Biloba standardized extract 24/6
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Ginkgo Biloba standardized extract 24/6 | Drug: Ginkgo biloba standardized extract 24/6<br>* tablets, 120 mg/day (60 mg two times daily) during 6 months<br>Drug: Ginkgo Biloba standardized extract 24/6<br>* tablets, 60 mg/day during 6 months<br>|
| Placebo Comparator: 3<br>placebo | Drug: placebo<br>* placebo during 6 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of MDRS |  | 6 months | 
| Changes of VFT |  | 6 months | 
| Changes of CGI |  | 6 months | 
| Changes of SCAG |  | 6 months | 
| Changes of MMSE |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of TCD, and color Doppler of carotid arteries |  | 6 months | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ginkgo biloba, cerebrovascular insufficiency, mild cognitive impairment, concentration impairment