NCT01046292

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2010

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

5.1 years

First QC Date

January 8, 2010

Last Update Submit

October 12, 2015

Conditions

Mild Cognitive Impairment

Keywords

Gait, Ginkgo biloba, mild cognitive impairment

Outcome Measures

Primary Outcomes (1)

  • gait speed

    baseline, 3, 6, 12 months

Secondary Outcomes (1)

  • cycle time variability

    baseline, 3, 6, 12 months

Study Arms (2)

Ginkgo biloba

EXPERIMENTAL
Drug: Ginkgo biloba

Placebo control

PLACEBO COMPARATOR
Drug: Ginkgo biloba

Interventions

Ginkgo bilobaDRUG

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
Ginkgo bilobaPlacebo control

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basel University Hospital, Basel Mobility Center

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Ginkgo Extract

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Reto W Kressig, MD, Prof.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2010

First Posted

January 11, 2010

Study Start

January 1, 2010

Primary Completion

February 1, 2015

Study Completion

October 1, 2015

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

CH(1)