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

Sponsored by:	Milsing d.o.o.
Information provided by:	Milsing d.o.o.
ClinicalTrials.gov Identifier:	NCT00446485

Purpose

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

Condition	Intervention	Phase
Mild Cognitive Impairment Cerebrovascular Insufficiency	Drug: Ginkgo biloba standardized extract 24/6 Drug: Ginkgo Biloba standardized extract 24/6 Drug: placebo	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Ginkgo Biloba Standardized Extract (24% Ginkoflavonoglicozides and 6% Terpenes) in Treatment of Mild Cognitive and Concentration Impairment

Further study details as provided by Milsing d.o.o.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	90
Study Start Date:	May 2007
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Ginkgo Biloba standardized extract 24/6	Drug: Ginkgo biloba standardized extract 24/6 tablets, 120 mg/day (60 mg two times daily) during 6 months Drug: Ginkgo Biloba standardized extract 24/6 tablets, 60 mg/day during 6 months
3: Placebo Comparator placebo	Drug: placebo placebo during 6 months

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446485

Contacts

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

Locations

Croatia
University Department of Neurology, Sestre milosrdnice University Hospital, Vinogradska 29	Recruiting
Zagreb, Croatia, 10000
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
Sub-Investigator: Marijana Lisak, MD
Sub-Investigator: Sandra Morovic, MD
Sub-Investigator: Iris Zavoreo, MD
Sub-Investigator: Miljenka Jelena Kesić, MD
Sub-Investigator: Irena Martinic Popovic, MD
Sub-Investigator: Mislav Budisic, MD
Sub-Investigator: Jelena Bosnjak, MD
Sub-Investigator: Sonja Antic, MD

Sponsors and Collaborators

Milsing d.o.o.

Investigators

Principal Investigator:

Vida Demarin, MD PHD

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

More Information

Responsible Party:	Sestra Milosrdnice University Hospital, Zagreb ( Vida Demarin MD PHD )
Study ID Numbers:	MIL-001
Study First Received:	March 12, 2007
Last Updated:	January 4, 2008
ClinicalTrials.gov Identifier:	NCT00446485
Health Authority:	Republic of Croatia: Ethic Committee of Sestre milosrdnice University Hospital

Keywords provided by Milsing d.o.o.:

ginkgo biloba
cerebrovascular insufficiency
mild cognitive impairment
concentration impairment

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Vascular Diseases
Central Nervous System Diseases
Dementia

Brain Diseases
Cerebrovascular Disorders
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009