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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00446485
• Other study ID #: MIL-001
• Status: Completed
• Phase: Phase 4
• First received: March 12, 2007
• Last updated: September 24, 2015
• Start date: May 2007
• Est. completion date: April 2010

Study information

• Verified date: September 2015
• Source: Milsing d.o.o.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

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

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Cerebrovascular Insufficiency
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Drug:
• Ginkgo biloba standardized extract 24/6
tablets, 120 mg/day (60 mg two times daily) during 6 months
• Ginkgo Biloba standardized extract 24/6
tablets, 60 mg/day during 6 months
• placebo
placebo during 6 months

Locations

Country	Name	City	State
Croatia	University Department of Neurology, Sestre milosrdnice University Hospital, Vinogradska 29	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
Milsing d.o.o.

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of MDRS		6 months
Primary	Changes of VFT		6 months
Primary	Changes of CGI		6 months
Primary	Changes of SCAG		6 months
Primary	Changes of MMSE		6 months
Secondary	Changes of TCD, and color Doppler of carotid arteries		6 months
Secondary	Changes of platelets, hematocrit, prothrombin time, and activated partial tromboplastin time		6 months
Secondary	Changes of total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides		6 months
Secondary	Safety will be assessed according to occurrence of adverse events during the trial		6 months