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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Mild Cognitive Impairment
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 29, 2014