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

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Ginkgo biloba
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Gait, Ginkgo biloba, mild cognitive impairment

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Basel University Hospital, Basel Mobility Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ginkgo biloba

Placebo control

Arm Description

Outcomes

Primary Outcome Measures

gait speed

Secondary Outcome Measures

cycle time variability

Full Information

First Posted
January 8, 2010
Last Updated
October 12, 2015
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT01046292
Brief Title
Effect of Ginkgo Biloba Special Extract LI 1370 on Dual-tasking in Patients With MCI
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Gait, Ginkgo biloba, mild cognitive impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ginkgo biloba
Arm Type
Experimental
Arm Title
Placebo control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ginkgo biloba
Other Intervention Name(s)
Symfona® forte
Intervention Description
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.
Primary Outcome Measure Information:
Title
gait speed
Time Frame
baseline, 3, 6, 12 months
Secondary Outcome Measure Information:
Title
cycle time variability
Time Frame
baseline, 3, 6, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reto W Kressig, MD, Prof.
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Basel University Hospital, Basel Mobility Center
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

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

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