Multicenter, Open-Label, Prospective Study Shows Safety and Therapeutic Benefits of a Defined Ginkgo Biloba Extract for Adults with Major Neurocognitive Disorder.

Introduction: The safety and therapeutic effects of Gingko biloba extract EGb 761® to treat cognitive decline have been demonstrated in numerous clinical trials. However, trials in Indian populations have been lacking.

Methods: This open-label, multicenter, single-arm, phase IV trial enrolled 150 patients aged ≥50 years with major neurocognitive disorder due to Alzheimer's disease, major vascular neurocognitive disorder, or mixed forms of both according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria and a Mini-Mental State Examination (MMSE) score of 12-24.

Extract EGb 761 in the Treatment of Patients with Mild Neurocognitive Impairment: A Systematic Review.

Background: Many clinical trials testing extract EGb 761 in patients with mild forms of cognitive impairment were conducted before widely accepted terms and diagnostic criteria for such conditions were available. This makes it difficult to compare any results from earlier and more recent trials. The objective of this systematic review was to provide a descriptive overview of clinical trials of EGb 761 in patients who met the diagnostic criteria for mild neurocognitive disorder (mild NCD) according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5).

Single and Repeated Doses of EGb 761 do not Affect Pharmacokinetics or Pharmacodynamics of Rivaroxaban in Healthy Subjects.

The present drug-drug interaction study investigates whether single or repeated doses of 240 mg extract EGb 761 alter the pharmacokinetics or pharmacodynamics of rivaroxaban in healthy subjects. This was a single-centre, two-period, fixed-sequence trial. In Period 1, rivaroxaban was taken alone.

EGb 761 Does Not Affect Blood Coagulation and Bleeding Time in Patients with Probable Alzheimer's Dementia-Secondary Analysis of a Randomized, Double-Blind Placebo-Controlled Trial.

Following reports of bleeding upon Ginkgo intake, we assessed whether Ginkgo extract EGb 761 affects coagulation or platelet function or increases the risk of bleeding. In a double-blind, placebo-controlled trial, prothrombin time, activated partial thromboplastin time, international normalized ratio and bleeding time were measured in patients with Alzheimer's dementia at baseline, weeks 6 and 26. A total of 513 patients were randomized to 120 mg ( = 169) or 240 mg EGb 761 ( = 170) or placebo ( = 174).

extract EGb 761 alleviates neurosensory symptoms in patients with dementia: a meta-analysis of treatment effects on tinnitus and dizziness in randomized, placebo-controlled trials.

Background: Tinnitus and dizziness are frequent in old age and often seen as concomitant symptoms in patients with dementia. In earlier clinical trials, extract EGb 761 was found to alleviate tinnitus and dizziness in elderly patients. Consequently, a meta-analysis was conducted to evaluate the effects of EGb 761 at a daily dose of 240 mg on tinnitus and dizziness associated with dementia.

Treatment effects of Ginkgo biloba extract EGb 761® on the spectrum of behavioral and psychological symptoms of dementia: meta-analysis of randomized controlled trials.

Unlabelled: ABSTRACTBackground:In randomized controlled trials, Ginkgo biloba extract EGb 761® has been found to be effective in the treatment of behavioral and psychological symptoms of dementia (BPSD).

Methods: To assess the effects of EGb 761® on specific BPSD, we analyzed data from all randomized, placebo-controlled, at least 20-week, trials of EGb 761® enrolling patients with dementia (probable Alzheimer's disease (AD), probable vascular dementia or probable AD with cerebrovascular disease) who had clinically significant BPSD (Neuropsychiatric Inventory (NPI) total score at least 6). Data were pooled and joint analyses of NPI single item composite and caregiver distress scores were performed by meta-analysis with a fixed effects model.

Towards the concept of disease-modifier in post-stroke or vascular cognitive impairment: a consensus report.

Background: Vascular cognitive impairment (VCI) is a complex spectrum encompassing post-stroke cognitive impairment (PSCI) and small vessel disease-related cognitive impairment. Despite the growing health, social, and economic burden of VCI, to date, no specific treatment is available, prompting the introduction of the concept of a disease modifier.

Consensus And Suggestions: Within this clinical spectrum, VCI and PSCI remain advancing conditions as neurodegenerative diseases with progression of both vascular and degenerative lesions accounting for cognitive decline.

Therapeutic efficacy of the Ginkgo special extract EGb761 within the framework of the mitochondrial cascade hypothesis of Alzheimer's disease.

Objectives: The mitochondrial cascade hypothesis of dementia assumes mitochondrial dysfunction as an important common pathomechanism for the whole spectrum of age-associated memory disorders from cognitive symptoms in the elderly over mild cognitive impairment to Alzheimer's dementia. Thus, a drug such as the Ginkgo special extract EGb 761 which improves mitochondrial function should be able to ameliorate cognitive deficits over the whole aging spectrum.

Methods: We review the most relevant publications about effects of EGb 761 on cognition and synaptic deficits in preclinical studies as well as on cognitive deficits in man from aging to dementia.

A retrospective classification of diagnoses in terms of DSM-5 for patients included in randomized controlled trials of Ginkgo biloba extract EGb 761(®).

When the early trials of Ginkgo biloba extract EGb 761(®) were conducted, different terms were used to denote ageing-associated neurocognitive disorders. With the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), a taxonomy covering dementia and pre-dementia stages of such disorders became available. DSM-5 diagnostic criteria for neurocognitive disorders (NCDs) were applied to patients with any type of ageing-associated cognitive impairment, including dementia, enrolled in randomized controlled clinical trials of EGb 761(®), taking into account the reported inclusion and exclusion criteria and patient characteristics at baseline.

Treatment of Vertigo: A Randomized, Double-Blind Trial Comparing Efficacy and Safety of Ginkgo biloba Extract EGb 761 and Betahistine.

A multicenter clinical trial was performed to compare the efficacy and safety of Ginkgo biloba extract EGb 761 and betahistine at recommended doses in patients with vertigo. One hundred and sixty patients (mean age 58 years) were randomly assigned to double-blind treatment with EGb 761 (240 mg per day) or betahistine (32 mg per day) for 12 weeks. An 11-point numeric analogue scale, the Vertigo Symptom Scale-short form, the Clinical Global Impression Scales and the Sheehan Disability Scale were used as outcome measures.

Sensitivity to change of composite and frequency scores of the neuropsychiatric inventory in mild cognitive impairment.

Background: The most appropriate means of capturing data from the Neuropsychiatric Inventory (NPI) must be understood to optimize use of this instrument in clinical trials. The utility of the composite score (frequency times severity) was recently demonstrated in mild and moderate dementia. Determination of frequency compared to composite scores in mild cognitive impairment (MCI) warrants investigation.

Recommendations for nanomedicine human subjects research oversight: an evolutionary approach for an emerging field.

The nanomedicine field is fast evolving toward complex, "active," and interactive formulations. Like many emerging technologies, nanomedicine raises questions of how human subjects research (HSR) should be conducted and the adequacy of current oversight, as well as how to integrate concerns over occupational, bystander, and environmental exposures. The history of oversight for HSR investigating emerging technologies is a patchwork quilt without systematic justification of when ordinary oversight for HSR is enough versus when added oversight is warranted.

Sensitivity to change of composite and frequency scores of the Neuropsychiatric Inventory in mild to moderate dementia.

Background: The Neuropsychiatric Inventory (NPI) is widely used to assess psychopathology in dementia. The scoring involves ratings of frequency and severity, as well as the calculation of a composite score. It was suggested recently that, due to lower variance, the frequency score might be more sensitive to detect treatment-related change and to discriminate active treatment from placebo than the composite score, particularly in milder forms of the disease.

Endothelial cell repopulation after stenting determines in-stent neointima formation: effects of bare-metal vs. drug-eluting stents and genetic endothelial cell modification.

Aims: Understanding endothelial cell repopulation post-stenting and how this modulates in-stent restenosis is critical to improving arterial healing post-stenting. We used a novel murine stent model to investigate endothelial cell repopulation post-stenting, comparing the response of drug-eluting stents with a primary genetic modification to improve endothelial cell function.

Methods And Results: Endothelial cell repopulation was assessed en face in stented arteries in ApoE(-/-) mice with endothelial-specific LacZ expression.

Ginkgo biloba extract EGb 761® in dementia with neuropsychiatric features: a randomised, placebo-controlled trial to confirm the efficacy and safety of a daily dose of 240 mg.

A multi-centre, double-blind, randomised, placebo-controlled, 24-week trial with 410 outpatients was conducted to demonstrate efficacy and safety of a 240 mg once-daily formulation of Ginkgo biloba extract EGb 761(®) in patients with mild to moderate dementia (Alzheimer's disease or vascular dementia) associated with neuropsychiatric symptoms. Patients scored 9 to 23 on the SKT cognitive battery, at least 6 on the Neuropsychiatric Inventory (NPI), with at least one of four key items rated at least 4. Primary outcomes were the changes from baseline to week 24 in the SKT and NPI total scores.

Alleviating neuropsychiatric symptoms in dementia: the effects of Ginkgo biloba extract EGb 761. Findings from a randomized controlled trial.

Purpose: To examine the effects of Ginkgo biloba extract EGb 761(®) on neuropsychiatric symptoms of dementia.

Patients And Methods: Randomized, controlled, double-blind, multicenter clinical trial involving 410 outpatients with mild to moderate dementia (Alzheimer's disease with or without cerebrovascular disease, vascular dementia), scoring at least 5 on the Neuropsychiatric Inventory (NPI), with at least one item score of 3 or more. Total scores on the SKT cognitive test battery (Erzigkeit's short syndrome test) were between 9 and 23.

Efficacy and safety of a once-daily formulation of Ginkgo biloba extract EGb 761 in dementia with neuropsychiatric features: a randomized controlled trial.

Objective: To test the efficacy and safety of a once-daily formulation of EGb 761 in the treatment of patients with dementia with neuropsychiatric features.

Methods: Multi-centre trial of 410 outpatients with mild to moderate dementia (Alzheimer's disease, vascular dementia or mixed form) scoring between 9 and 23 on the SKT cognitive test battery, at least five on the Neuropsychiatric Inventory (NPI) and three or higher in at least one item of the NPI. Patients were randomly allocated to double-blind treatment with 240 mg of EGb 761 or placebo once daily for 24 weeks.

Drug-eluting stent coatings.

This paper reviews the development of coronary stents from a polymer scientist's view point, and presents the first results of an interdisciplinary team assembled for the development of new stent systems. Poly(styrene-b-isobutylene-b-styrene) block copolymer (SIBS), a nanostructured thermoplastic elastomer, is used in clinical practice as the drug-eluting polymeric coating on the Taxus coronary stent (trademark of Boston Scientific Co.).

Effect of the coating morphology on the drug release from engineered drug-polymer nanocomposites.

The ElectroNanospray process (Nanocopoeia, Inc) transforms drugs and polymers into many nanoscale material states including powders, liquids, encapsulated particles, and coatings. This enabling technology platform allows application of polymers and drugs to the surface of medical devices such as coronary stents in a single-stage process. Modification of ElectroNanospray process parameters resulted in surface coatings with rich morphologies ranging in appearance from smooth and heterogeneous to highly porous and rough (open matrix).

Multimodal dynamic imaging of therapeutic biomedical coatings in aqueous medium.

Drug release from therapeutic biomedical films such as drug-polymer composite coatings on drug eluting stents is a highly complex and poorly understood process. The dynamics of drug release and the evolution of surface morphology during release have direct impact on the performance of the device. This information is not easily accessible, and there have been few systematic studies to investigate drug release from biomedical coatings in real time.

In vitro and in vivo effects of the probiotic Escherichia coli strain M-17: immunomodulation and attenuation of murine colitis.

We examined the in vitro and in vivo effects of a probiotic, Escherichia coli strain M-17 (EC-M17), on NF-kappaB signalling, cytokine secretion and efficacy in dextran sulfate sodium (DSS)-induced murine colitis. NF-kappaB signalling was assessed using an NF-kappaB luciferase reporter cell line that was stimulated with TNF-alpha (100 ng/ml). p65 Nuclear binding and cytokine secretion (TNF-alpha, IL-1beta and IL-6) were evaluated using a RAW 264.

A randomized, double-blind, placebo-controlled trial of two doses of Ginkgo biloba extract in dementia of the Alzheimer's type.

Context: Previous studies of Ginkgo biloba extract (GbE) in patients with various forms of cognitive impairment or dementia have shown promising results.

Objective: To determine the clinical efficacy of GbE in mild to moderate dementia of the Alzheimer type.

Design: Randomized, placebo-controlled, double-blind, parallel-group, multicenter trial.

Ensaculin (KA-672 HCl): a multitransmitter approach to dementia treatment.

Ensaculin, a novel benzopyranone substituted with a piperazine moiety, showed memory-enhancing effects in paradigms of passive and conditioned avoidance in both normal and artificially amnesic rodents. It exhibited neuroprotective activities in an NMDA toxicity model and neurotrophic effects in primary cultured rat brain cells. The compound could be characterized as a weak NMDA receptor-operated channel blocker.