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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Milsing d.o.o..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Milsing d.o.o.
ClinicalTrials.gov Identifier:
NCT00446485
First received: March 12, 2007
Last updated: February 4, 2009
Last verified: February 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Ginkgo Biloba Standardized Extract (24% Ginkoflavonoglicozides and 6% Terpenes) in Treatment of Mild Cognitive and Concentration Impairment

Resource links provided by NLM:


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: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
Placebo Comparator: 3
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Vida Demarin MD PHD, Sestra Milosrdnice University Hospital, Zagreb
ClinicalTrials.gov Identifier: NCT00446485     History of Changes
Other Study ID Numbers: MIL-001
Study First Received: March 12, 2007
Last Updated: February 4, 2009
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

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Cerebrovascular Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014