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

Phase 4

Completed

• Conditions: Mild Cognitive Impairment; Cerebrovascular Insufficiency
• Interventions: Drug: placebo; Drug: Ginkgo Biloba standardized extract 24/6

• Registration Number: NCT00446485
• Lead Sponsor: Milsing d.o.o.

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.

Study Timeline

• Study First Submitted: 2007-03-12
• Study First Submitted QC: 2007-03-12
• Study First Posted: 2007-03-13
• Study Start: 2007-05
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-24
• Last Update Posted: 2015-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	placebo	placebo
1	Ginkgo Biloba standardized extract 24/6	Ginkgo Biloba standardized extract 24/6

Primary Outcome Measures

Name	Time	Method
Changes of VFT	6 months
Changes of CGI	6 months
Changes of SCAG	6 months
Changes of MMSE	6 months
Changes of MDRS	6 months

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

University Department of Neurology, Sestre milosrdnice University Hospital, Vinogradska 29; 🇭🇷 Zagreb, Croatia