Ginkgo biloba special extract LI 1370 improves dual-task walking in patients with MCI: a randomised, double-blind, placebo-controlled exploratory study
Aging Clin Exp Res
Ginkgo biloba special extract LI 1370 improves dual-task walking in patients with MCI: a randomised, double-blind, placebo- controlled exploratory study
Yves J. Gschwind 0 1 2 4 5 6 7
Stephanie A. Bridenbaugh 0 1 2 4 5 6 7
Sarah Reinhard 0 1 2 4 5 6 7
Urs Granacher 0 1 2 4 5 6 7
Andreas U. Monsch 0 1 2 4 5 6 7
Reto W. Kressig 0 1 2 4 5 6 7
0 Memory Clinic, Felix Platter Hospital, University Center for Medicine of Aging , Burgfelderstrasse 101, 4055 Basel , Switzerland
1 Division of Training and Movement Sciences, Research Focus Cognition Sciences, University of Potsdam , Am Neuen Palais 10, Building 12, 14469 Potsdam , Germany
2 Felix Platter Hospital, Basel Mobility Center, University Center for Medicine of Aging , Burgfelderstrasse 101, 4055 Basel , Switzerland
3 Yves J. Gschwind
4 Keyword Gait · Walking · Executive function · Mild cognitive impairment · Cognitive enhancer · Ginkgo biloba extract
5 Faculty of Medicine, University of Basel , Basel , Switzerland
6 Felix Platter Hospital, University Center for Medicine of Aging , Burgfelderstrasse 101, 4055 Basel , Switzerland
7 Faculty of Psychology, University of Basel , Basel , Switzerland
Background In patients with mild cognitive impairment (MCI), gait instability, particularly in dual-task situations, has been associated with impaired executive function and an increased fall risk. Ginkgo biloba extract (GBE) could be an effective mean to improve gait stability. Aims This study investigated the effect of GBE on spatiotemporal gait parameters of MCI patients while walking under single and dual-task conditions. Methods Fifty patients aged 50-85 years with MCI and associated dual-task-related gait impairment participated in this randomised, double-blind, placebo-controlled, exploratory phase IV drug trial. Intervention group (IG) patients received GBE (Symfona® forte 120 mg) twice-daily for 6 months while control group (CG) patients received placebo capsules. A 6-month open-label phase with identical GBE dosage followed. Gait was quantified at months 0, 3, 6 and 12.
Introduction
Safe and efficient gait is crucial for mobility,
independence and quality of life in older people [
1
]. For decades,
it was generally considered that gait was regulated at the
spinal level. The development of neuroimaging (e.g.
magnetic resonance imaging) and electrophysiological
technologies (e.g. transcranial magnetic stimulation) have
led to a greater understanding of the neuro-motor control
of gait. It has been recently reported that frontal and
central brain regions, specifically executive functions which
depend upon the integrity of the prefrontal cortex, play a
key role in gait control during single and dual-task
walking [
2, 3
]. In cognitive disorders, such as mild cognitive
impairment (MCI) and dementia, executive functions, and
thus gait control are impaired [4]. Studies suggest that the
administration of cognitive enhancers might be effective in
improving both, executive functions and gait performance
[
5
].
Currently, there is limited knowledge about efficient
drug interventions in older people with MCI [
6
]. A recent
meta-analysis of 2625 patients with dementia showed that
treatment with Ginkgo biloba extract (GBE) 120 or 240 mg
daily over 22 weeks can improve cognition and activities of
daily living [
7
]. In vitro and in vivo studies have described
modes of GBE action which include
vasomodulatory/vasotropic, antagonistic platelet activating factor, antioxidant,
metabolic, anti-apoptotic, neuroprotective, and receptor as
well as (neuro-) transmitter modulating properties [
8–11
].
GBE may also increase cerebral blood flow
microcirculation and reduce vascular permeability [11].
Older people with MCI can show deficits in cerebral
blood flow [
12
]. Particularly, reduced cerebral blood flow in
the frontal lobe was reported to be significantly associated
with impaired gait performance (i.e. decreased gait
velocity, increased gait variability) [
13
]. Since GBE improves
cerebral microcirculation, it may also improve circulation
in the prefrontal cortex [
14
], which may, in turn, improve
executive functions, and thus gait stability.
This study aimed to elucidate the effects of GBE on
spatio-temporal gait parameters during single and
dualtask walking in MCI patients. We hypothesised that MCI
patients treated with GBE will show a change in gait
stability in dual-task walking compared to those MCI patients
treated with placebo. Primary and secondary endpoints
were gait velocity and stride time variability in dual-task
walking conditions, respectively. In addition, compliance to
study medication and safety were evaluated.
Methods
Study framework
Fifty older patients diagnosed with MCI and associated
dual-task-related gait impairment participated in this
randomised, double-blind, placebo-controlled, exploratory
phase IV drug trial. This single-centre study took place at
the University of Basel Hospital, Division of Acute
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