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

This study has been completed.
Information provided by (Responsible Party):
Professor of Neurology Vida Demarin, MD, PhD, Milsing d.o.o. Identifier:
First received: March 12, 2007
Last updated: September 24, 2015
Last verified: September 2015
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]
  • Changes of VFT [ Time Frame: 6 months ]
  • Changes of CGI [ Time Frame: 6 months ]
  • Changes of SCAG [ Time Frame: 6 months ]
  • Changes of MMSE [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Changes of TCD, and color Doppler of carotid arteries [ Time Frame: 6 months ]
  • Changes of platelets, hematocrit, prothrombin time, and activated partial tromboplastin time [ Time Frame: 6 months ]
  • Changes of total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides [ Time Frame: 6 months ]
  • Safety will be assessed according to occurrence of adverse events during the trial [ Time Frame: 6 months ]

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
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.

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00446485

University Department of Neurology, Sestre milosrdnice University Hospital, Vinogradska 29
Zagreb, Croatia, 10000
Sponsors and Collaborators
Milsing d.o.o.
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. Identifier: NCT00446485     History of Changes
Other Study ID Numbers: MIL-001
Study First Received: March 12, 2007
Last Updated: September 24, 2015

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 processed this record on May 22, 2017