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

Tracking Information

First Received Date ^ICMJE

March 12, 2007

Last Updated Date

February 4, 2009

Start Date ^ICMJE

May 2007

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Changes of MDRS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Changes of VFT [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Changes of CGI [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Changes of SCAG [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Changes of MMSE [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Changes of MDRS at 6 months
Changes of VFT at 6 months
Changes of CGI at 6 months
Changes of SCAG at 6 months
Changes of MMSE at 6 months

Change History

Complete list of historical versions of study NCT00446485 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Changes of TCD, and color Doppler of carotid arteries [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Changes of platelets, hematocrit, prothrombin time, and activated partial tromboplastin time [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Changes of total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Safety will be assessed according to occurrence of adverse events during the trial [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Changes of TCD, and color Doppler of carotid arteries at 6 months
Changes of platelets, hematocrit, prothrombin time, and activated partial tromboplastin time at 6 months
Changes of total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides at 6 months
Safety will be assessed according to occurrence of adverse events during the trial

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Mild Cognitive Impairment
Cerebrovascular Insufficiency

Intervention ^ICMJE

Drug: Ginkgo biloba standardized extract 24/6
Drug: Ginkgo Biloba standardized extract 24/6
Drug: placebo

Study Arms / Comparison Groups

Active Comparator: Ginkgo Biloba standardized extract 24/6
Placebo Comparator: placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2009

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Vida Demarin, MD, PhD	00385 1 3787740	vida.demarin@zg.t-com.hr
Contact: Zlatko Trkanjec, MD, PhD	00385 1 3787169	ztrkanj@kbsm.hr

Location Countries ^ICMJE

Croatia

Administrative Information

NCT ID ^ICMJE

NCT00446485

Responsible Party

Vida Demarin MD PHD, Sestra Milosrdnice University Hospital, Zagreb

Study ID Numbers ^ICMJE

MIL-001

Study Sponsor ^ICMJE

Milsing d.o.o.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Vida Demarin, MD PHD

University Department of Neurology, Sestre milosrdnice University Hospital, Vinogradska 29, HR-10000 Zagreb, Croatia

Information Provided By

Milsing d.o.o.

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP