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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Professor of Neurology Vida Demarin, MD, PhD, Milsing d.o.o.
ClinicalTrials.gov Identifier:
NCT00446485
First received: March 12, 2007
Last updated: September 24, 2015
Last verified: September 2015
  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 ]

Enrollment: 90
Study Start Date: May 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (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   (Adult, Senior)
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

Locations
Croatia
University Department of Neurology, Sestre milosrdnice University Hospital, Vinogradska 29
Zagreb, Croatia, 10000
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: Professor of Neurology Vida Demarin, MD, PhD, MD, PhD, FAAN, FAHA, FESO Fellow of Croatian Academy of Sciences and Arts Professor of Neurology, Milsing d.o.o.
ClinicalTrials.gov Identifier: NCT00446485     History of Changes
Other Study ID Numbers: MIL-001 
Study First Received: March 12, 2007
Last Updated: September 24, 2015
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
Neurocognitive Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 24, 2016