Effect of Ginkgo Biloba Special Extract LI 1370 on Dual-tasking in Patients With MCI
NCT ID: NCT01046292
Last Updated: 2015-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2010-01-31
2015-10-31
Brief Summary
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The primary endpoint in the evaluation of GBE efficacy is gait speed. The secondary endpoint is cycle time variability under dual-task conditions.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ginkgo biloba
Ginkgo 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.
Placebo control
Ginkgo 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.
Interventions
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Ginkgo 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
50 Years
85 Years
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Reto W Kressig, MD, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
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Basel University Hospital, Basel Mobility Center
Basel, Canton of Basel-City, Switzerland
Countries
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Other Identifiers
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GBE LI 1370
Identifier Type: -
Identifier Source: org_study_id
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