Ginkgo biloba special extract LI 1370 improves dual-task walking in patients with MCI: a randomised, double-blind, placebo-controlled exploratory study

Aging Clinical and Experimental Research, Feb 2017

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 spatio-temporal 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. Results After 6 months, dual-task-related cadence increased in the IG compared to the CG (p = 0.019, d = 0.71). No significant changes, but GBE-associated numerical non-significant trends were found after 6-month treatment for dual-task-related gait velocity and stride time variability. Discussion Findings suggest that 120 mg of GBE twice-daily for at least 6 months may improve dual-task-related gait performance in patients with MCI. Conclusions The observed gait improvements add to the understanding of the self-reported unspecified improvements among MCI patients when treated with standardised GBE.

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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 Geri (...truncated)


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Yves J. Gschwind, Stephanie A. Bridenbaugh, Sarah Reinhard, Urs Granacher, Andreas U. Monsch, Reto W. Kressig. Ginkgo biloba special extract LI 1370 improves dual-task walking in patients with MCI: a randomised, double-blind, placebo-controlled exploratory study, Aging Clinical and Experimental Research, 2017, pp. 609-619, Volume 29, Issue 4, DOI: 10.1007/s40520-016-0699-y