Could a Cure for Alzheimer’s be Invented in the Triangle? Absolutely.

By The Editors of Talking Trials,
Old people with neurodegenerative diseases

Currently, the estimated annual cost of nine common neurological diseases totals to $800 billion, predictably increasing as the elderly population doubles by 2050. More specifically, there is a catastrophic unmet need in Alzheimer’s disease treatment, prevention and clinical research. In a recent segment with WRAL News’ Health Team with Dr. Allen Mask, Worldwide Clinical Trials’ chief operating officer, Peter Benton, discusses Worldwide’s uncommon approach to fighting against neurodegenerative diseases through its recent partnership with Datavant.

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GeNeuro and Worldwide Pursue First Clinical Efficacy Study of Breakthrough MS Drug

By The Editors of Talking Trials,
Multiple Sclerosis

Worldwide Clinical Trials recently teamed up with GeNeuro, a clinical stage pharmaceutical company, to develop a new approach to the treatment of autoimmune diseases. Currently, the teams are working on the first clinical efficacy study of GNbAC1, a promising new approach for the treatment of Multiple Sclerosis.

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Secure, Real-World Data Drives Enhanced Insights for Neurodegenerative Disease Trials

By Dr. Natalia Drosopoulou, Executive Director of Project Management and Franchise Area Lead in Neuroscience, Worldwide Clinical Trials,
Neurodegenerative diseases

Neurodegenerative disease clinical trials are challenging, but they don’t have to be. Optimizing clinical trial patient recruitment and outcomes with external data sets can open new opportunities for pharma and biotech companies seeking to enhance their clinical trials in areas such as compliance, adherence, enrollment, safety, and even efficacy.

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A Methodology for Advancing the Selection of Biomarkers for Use in Psychiatric Clinical Trials – Part 1

By Natalia Drosopoulou, Ph.D., Executive Director of Global Project Management, Neuroscience, Worldwide Clinical Trials,
biomarkers in brain diagnostics

  For this two-part blog series, Talking Trials asked Worldwide’s Dr. Drosopoulou, author of the recent article, “A Methodology for Advancing the Selection of Biomarkers for Use in Psychiatric Clinical Trials,” published in the Journal for Clinical Studies, to weigh in on the use of biomarkers for clinical research. Clinical trials using biomarkers in patient selection have higher overall success probabilities than clinical trials without biomarkers.1 That’s one of the many compelling results from a recent study of drug development success published in the journal Biostatistics. Wong and colleagues found clinical trials using biomarkers to stratify patients exhibit almost twice the overall probability of success compared to trials without biomarkers (10.3% vs. 5.5%).

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Treatment-Resistant Schizophrenia – New Definitions for Research and Clinical Use

By Bartosz Janikowski, M.D., Vice President, Medical & Scientific Affairs, Worldwide Clinical Trials,

Treatment-resistant schizophrenia is a phenomenon that most clinicians and researchers try to combat in their daily practices. Treatment-resistant schizophrenics are patients who are repeatedly admitted to hospitals or require frequent visits to specialists or, as study subjects, are often excluded from participation in efficacy and safety studies of new antipsychotic medications. That said, the research community faced various definitions of treatment-resistance and response to schizophrenia treatments and was also often not looking specifically into the issue of the adequate adherence to treatments provided sometimes resulting in confusion between treatment resistance and potential resistance to treatment.

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Parkinson’s Clinical Trials: MDS-PD Criteria Implications

By Tomislav Babic, MD, PhD, Vice President Neuroscience Franchise, Worldwide Clinical Trials,
UK Parkinson's Society Brain Bank criteria

Second only to Alzheimer’s disease, Idiopathic Parkinson’s Disease (IPD) is one of the most common neurodegenerative disorders. Despite its prevalence, approximately 5 to 10% of patients with IPD are misdiagnosed, and conversely, up to 20% of patients diagnosed with IPD reveal alternative diagnoses upon autopsy, such as multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, Ad type pathology, and cerebrovascular disease. Improving Accuracy with MDS-PD It has been suggested that an accuracy of 90% is the best that can be achieved with clinical assessment and existing Parkinson’s disease diagnostic criteria, such as the UK PD Society Brain Bank criteria. In an effort to improve on this and increase diagnostic specificity, the Movement Disorders Society (MDS) recently published Clinical Diagnostic Criteria for Parkinson’s disease (MDS-PD), which reflects more recent understanding of IPD. Increasing Recognition to Non-Motor Manifestations Designed specifically for use in clinical research, but also as a general guide to clinical diagnosis of IPD consequent to Lewy body pathology1, the updated Parkinson’s disease diagnostic criteria gives increasing recognition to non-motor manifestations (motor abnormalities remain central). As with previous diagnostic criteria, the MDS-PD criteria utilize a two-step process for diagnoses. First, parkinsonism, defined as bradykinesia in combination with either rest tremor, rigidity or both, is required. However, this definition of parkinsonism fails to take into consideration a loss of postural reflexes,...

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Dementia Research: What Can Nrf2 Do For You—and Our Aging Brains?

By Tomislav Babic, M.D., Ph.D.,
Dementia, Nrf2, Aging Brain

Nrf2 has garnered a lot of attention in the field of dementia research. Following are some of the latest scientific breakthroughs that may influence the way we approach central nervous system (CNS) and dementia clinical research over the next few years.

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