Mild Cognitive Impairment
Conditions
Keywords
Gait, Ginkgo biloba, mild cognitive impairment
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.
Interventions
DRUGGinkgo biloba
The participants will be randomly allocated to either the intervention group or the placebo control group at a ratio of 1:1. After six months, GBE will be administered to all participants for another 6 months for free. The daily administered dose (taken with meals in the morning and evening) will consist of either twice-daily 1 capsule of Symfona® forte 120mg GBE or identically appearing placebo.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| gait speed | baseline, 3, 6, 12 months |
Secondary
| Measure | Time frame |
|---|---|
| cycle time variability | baseline, 3, 6, 12 months |
Countries
Switzerland
Outcome results
None listed