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

University Hospital Basel

Status and phase: Completed; Phase 4

Conditions: Mild Cognitive Impairment

Treatments: Drug: Ginkgo biloba

Study type: Interventional

Funder types: Other

Identifiers

NCT01046292

GBE LI 1370

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Ginkgo biloba

Experimental group

Treatment:

Drug: Ginkgo biloba

Placebo control

Placebo Comparator group

Treatment:

Drug: Ginkgo biloba