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CompletedNCT01046292Updated Oct 14, 2015

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

A Phase 4 interventional study of Ginkgo biloba in Mild Cognitive Impairment, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-10-14.

Sponsored by University Hospital, Basel, Switzerland · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study 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.

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Conditions studied

  • Mild Cognitive Impairment

Keywords

  • Gait, Ginkgo biloba, mild cognitive impairment
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In context

Cognitive Dysfunction

3,845 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's enrollment of 50 is below the median of 64 across 2,810 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Ginkgo biloba

    Drug: Ginkgo biloba

  • Placebo comparator
    Placebo control

    Drug: Ginkgo biloba

Interventions

  • DrugGinkgo 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.

    Also known as: Symfona® forte

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What researchers measure

Primary outcomes

  1. gait speed

    Time frame: baseline, 3, 6, 12 months

Secondary outcomes

  1. cycle time variability

    Time frame: baseline, 3, 6, 12 months

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Study locations

1 site
  • Basel University Hospital, Basel Mobility Center
    Basel, Basel-Stadt 4031, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01046292
Lead sponsor
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
Jan 11, 2010
Start date
Jan 2010
Primary completion
Feb 2015
Completion
Oct 2015
Last update
Oct 14, 2015

Study contacts

Reto W Kressig, MD, Prof.
principal investigator · University Hospital, Basel, Switzerland

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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