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

Mild Cognitive Impairment Clinical Trial

Official title:

Effect of Ginkgo Biloba Special Extract LI 1370 on Dual-tasking in Patients With MCI: a Randomized, Double-blind, Placebo-controlled Exploratory Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046292
• Other study ID #: GBE LI 1370
• Status: Completed
• Phase: Phase 4
• First received: January 8, 2010
• Last updated: October 12, 2015
• Start date: January 2010
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Switzerland	Basel University Hospital, Basel Mobility Center	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gait speed		baseline, 3, 6, 12 months	Yes
Secondary	cycle time variability		baseline, 3, 6, 12 months	Yes