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International Clinical Trials

Non-Invasive Novel Biomarkers to Predict Alzheimer’s Risk

Since the National Institute on Aging and Alzheimer’s Association issued its 2011 guidelines delineating separate diagnostic recommendations for preclinical, mild cognitive impairment, and dementia stages, Alzheimer’s disease (AD) research has moved on. As a neurodegenerative syndrome, diagnosis initially hinged on the clinical picture, cognitive testing, and MRIs. More recently, however, this extremely complex disease continuum has come to be defined, primarily, by its biological manifestations.

Defining the disease by its biology enables more consistent characterisation and aids in understanding the disease and its mechanisms better (1). At the same time, it enables greater precision in clinical trials (1). With the revolution toward personalised and precision medicine, in the realm of AD, biomarkers are crucial. Biomarkers related to precise states and stages of the disease, at an individual level, are needed to provide the best patient management options, and are also needed as clinical trial endpoints to help further our understanding of this multifactorial disease.

Because of the intense search for effective biomarkers for AD and for central nervous system disease in general, the race toward validation of new biomarkers in these indications is fast-paced and exciting. This article discusses current biomarkers and non-invasive, investigational biomarkers for research and diagnosis of Alzheimer’s disease, as well as clinical trial partner capabilities that may be helpful along the path to development.

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Since May 2018, Simon Samaan PharmD, PhD, is a Clinical Pathologist and has directed the diagnosis of metabolism pathologies, AD biomarkers, and pharmacogenetics at Laboratoire Cerba in France. He is also in charge of the French national colorectal cancer screening test programme. After a Master’s in Human Genetics and a PhD in Fundamental Bases of Oncogenesis from Paris Diderot – Sorbonne University, France, in 2013, Simon joined the genetics department of Robert Debré University Hospital in Paris where he developed the next-generation sequencing tools for the molecular diagnosis of white matter disorders (leukodystrophy). Simon is a member of many French medical and scientific societies, such as French Society of Inherited Metabolic Diseases, L’Association Nationale des Praticiens de Génétique Moléculaire, Association Française de Génie Civil, and the National Pharmacogenetic Network.

With nearly 20 years in the scientific and medical research and industry, Jérôme Sallette, PhD, is the Chief Scientific Officer of Cerba HealthCare and Cerba Research, a division of Cerba HealthCare providing global central lab testing and evaluation for clinical trials and diagnostics trials. After five years in the high-content imaging industry, he joined Cerba HealthCare in 2010 and occupied various roles and executive positions in marketing, innovation and science. Jérôme is an engineer in physics and chemistry from ESPCI Paris, France. He graduated from Paris 7/Denis Diderot University, France, in physics biology interface and holds a PhD in neurobiology from the Pasteur Institute in Paris. He also graduated from the ESSEC Business School, France.
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