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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01046292
First received: January 8, 2010
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Mild Cognitive Impairment
Drug: Ginkgo biloba
Phase 4

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

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • gait speed [ Time Frame: baseline, 3, 6, 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • cycle time variability [ Time Frame: baseline, 3, 6, 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: January 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ginkgo biloba 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.
Other Name: Symfona® forte
Placebo Comparator: Placebo control 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.
Other Name: Symfona® forte

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046292

Locations
Switzerland
Basel University Hospital, Basel Mobility Center
Basel, Basel-Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Reto W Kressig, MD, Prof. University Hospital, Basel, Switzerland
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01046292     History of Changes
Other Study ID Numbers: GBE LI 1370
Study First Received: January 8, 2010
Last Updated: April 15, 2014
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
Gait, Ginkgo biloba, mild cognitive impairment

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014