Back to resultsEfficacy and Safety of Ginkgo Biloba Extract in Mild Cognitive Impairment and Cerebrovascular Insufficiency
Primary Purpose
Mild Cognitive Impairment, Cerebrovascular Insufficiency
Status
Completed
Phase
Phase 4
Locations
Croatia
Study Type
Interventional
Intervention
Ginkgo biloba standardized extract 24/6
Ginkgo Biloba standardized extract 24/6
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring ginkgo biloba, cerebrovascular insufficiency, mild cognitive impairment, concentration impairment
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
Sites / Locations
- University Department of Neurology, Sestre milosrdnice University Hospital, Vinogradska 29
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
3
Arm Description
Ginkgo Biloba standardized extract 24/6
placebo
Outcomes
Primary Outcome Measures
Changes of MDRS
Changes of VFT
Changes of CGI
Changes of SCAG
Changes of MMSE
Secondary Outcome Measures
Changes of TCD, and color Doppler of carotid arteries
Changes of platelets, hematocrit, prothrombin time, and activated partial tromboplastin time
Changes of total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides
Safety will be assessed according to occurrence of adverse events during the trial
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00446485
Brief Title
Efficacy and Safety of Ginkgo Biloba Extract in Mild Cognitive Impairment and Cerebrovascular Insufficiency
Official Title
Efficacy and Safety of Ginkgo Biloba Standardized Extract (24% Ginkoflavonoglicozides and 6% Terpenes) in Treatment of Mild Cognitive and Concentration Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milsing d.o.o.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Cerebrovascular Insufficiency
Keywords
ginkgo biloba, cerebrovascular insufficiency, mild cognitive impairment, concentration impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Ginkgo Biloba standardized extract 24/6
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Ginkgo biloba standardized extract 24/6
Intervention Description
tablets, 120 mg/day (60 mg two times daily) during 6 months
Intervention Type
Drug
Intervention Name(s)
Ginkgo Biloba standardized extract 24/6
Intervention Description
tablets, 60 mg/day during 6 months
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo during 6 months
Primary Outcome Measure Information:
Title
Changes of MDRS
Time Frame
6 months
Title
Changes of VFT
Time Frame
6 months
Title
Changes of CGI
Time Frame
6 months
Title
Changes of SCAG
Time Frame
6 months
Title
Changes of MMSE
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes of TCD, and color Doppler of carotid arteries
Time Frame
6 months
Title
Changes of platelets, hematocrit, prothrombin time, and activated partial tromboplastin time
Time Frame
6 months
Title
Changes of total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides
Time Frame
6 months
Title
Safety will be assessed according to occurrence of adverse events during the trial
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vida Demarin, MD PHD
Organizational Affiliation
University Department of Neurology, Sestre milosrdnice University Hospital, Vinogradska 29, HR-10000 Zagreb, Croatia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Department of Neurology, Sestre milosrdnice University Hospital, Vinogradska 29
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Ginkgo Biloba Extract in Mild Cognitive Impairment and Cerebrovascular Insufficiency
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