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

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Basel, Switzerland

Criteria

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