Effect of Ginkgo Biloba Special Extract LI 1370 on Dual-tasking in Patients With MCI

Phase 4

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Drug: Ginkgo biloba

• Registration Number: NCT01046292
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

The aim of this study is to evaluate the effects of Ginkgo Biloba Extract (GBE) in executive function-impaired Mild Cognitive Impairment (MCI) patients by assessing gait while walking alone as well as under differing dual-task conditions.

The primary endpoint in the evaluation of GBE efficacy is gait speed. The secondary endpoint is cycle time variability under dual-task conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-08
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-11
• Primary Completion: 2015-02
• Status Verified: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-12
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age 50-85 years
• Swiss German or German speaker
• Completed elementary school
• Impaired executive function (gait speed reduction ≥ 10% under dual-task as compared to normal walking)
• No dementia according to International Classifications of Diseases (ICD)-10 and Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV.
• Cognitive decline (self/informant report or objective task)
• Preserved basic activities of daily living and minimal impairment in complex instrumental functions
• Written informed consent and nihil obstat

Exclusion Criteria

• Current drug treatment with Warfarin-like drugs (Coumarins or Clopidogrel), however, acetylsalicylic acid 100mg and 300mg is permitted
• Current intake of GBE or during the last 6 months
• Known hypersensitivity to GBE or its constituents
• Regular intake of antipsychotic, anxiolytic or sedative drugs(allowed if clinically stable for at least the past 3 months while under treatment)
• Concomitant gait-relevant disorders: severe cardio/pulmonary/cerebron -vascular disorders, bleeding diathesis, polyneuropathy and severe orthopedic disorders, organic cerebral disease epilepsy, low vision
• Severe medical conditions (e.g. chronic renal insufficiency, severe hepatic disorders,cardio-vascular disease, uncontrolled hypertension, peptic ulcer, malignoma)
• Participation in another clinical intervention study within the last 2 months
• Use of walking aid
• Normal walking speed is < 100cm/s

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ginkgo biloba	Ginkgo biloba	-
Placebo control	Ginkgo biloba	-

Primary Outcome Measures

Name	Time	Method
gait speed	baseline, 3, 6, 12 months

Secondary Outcome Measures

Name	Time	Method
cycle time variability	baseline, 3, 6, 12 months

Trial Locations

Locations (1)

Basel University Hospital, Basel Mobility Center; 🇨🇭 Basel, Basel-Stadt, Switzerland