Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-24 @ 3:38 PM
NCT ID:
NCT01046292
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT01046292
Study Brief:
Protocol Section:
NCT01046292