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

Milsing

Status and phase: Completed; Phase 4

Conditions: Mild Cognitive Impairment; Cerebrovascular Insufficiency

Treatments: Drug: Ginkgo biloba standardized extract 24/6; Drug: placebo; Drug: Ginkgo Biloba standardized extract 24/6

Study type: Interventional

Funder types: Other

Identifiers

NCT00446485

MIL-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Ginkgo Biloba standardized extract 24/6

Treatment:

Drug: Ginkgo biloba standardized extract 24/6

3

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo