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Completed

NCT Number: NCT00446485

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

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

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Key information

Conditions

Mild Cognitive Impairment Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cerebrovascular Insufficiency Cognition Disorders Cognitive Dysfunction Mental Disorders Nervous System Diseases Neurocognitive Disorders Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Department of Neurology, Sestre milosrdnice University Hospital, Vinogradska 29

Zagreb, 10000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ginkgo biloba standardized extract 24/6

Drug

tablets, 120 mg/day (60 mg two times daily) during 6 months

Placebo

Drug

placebo during 6 months

Primary outcomes

  1. Changes of MDRS

    Time frame: 6 months

  2. Changes of VFT

    Time frame: 6 months

  3. Changes of CGI

    Time frame: 6 months

  4. Changes of SCAG

    Time frame: 6 months

  5. Changes of MMSE

    Time frame: 6 months

Secondary outcomes

  1. Changes of TCD, and color Doppler of carotid arteries

    Time frame: 6 months

  2. Changes of platelets, hematocrit, prothrombin time, and activated partial tromboplastin time

    Time frame: 6 months

  3. Changes of total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides

    Time frame: 6 months

  4. Safety will be assessed according to occurrence of adverse events during the trial

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Milsing d.o.o.

Other

Registry information

Official study title

Efficacy and Safety of Ginkgo Biloba Standardized Extract (24% Ginkoflavonoglicozides and 6% Terpenes) in Treatment of Mild Cognitive and Concentration Impairment

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Mar 13, 2007
Registry last updated
Sep 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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