Using CSF Biomarkers of Alzheimer’s Disease in Early Clinical Development

Alzheimer’s disease is a progressive brain disorder that becomes increasingly common with aging. As the global population ages, Alzheimer’s disease is rapidly becoming an urgent public health challenge; it now affects 35 million individuals worldwide and is projected to affect 115 million by 2050 if effective therapeutics are not developed.

To date, no disease-modifying therapy has been successful. This lack of success may be partly explained by Alzheimer’s disease having a complex etiology and considerable heterogeneity in its pathophysiology, and by limitations in past clinical trial designs, which have generally enrolled participants later in the course of the disease.

There is increasing evidence demonstrating the high sensitivity and specificity of cerebrospinal fluid (CSF) biomarkers for Alzheimer’s disease, contributing to accurate and earlier diagnosis and aiding the differential diagnosis of Alzheimer’s disease from other dementia etiologies. Because CSF is in direct contact with the extracellular space in the brain, CSF biomarkers are considered to reflect biochemical changes in the brain better than other biological fluids such as plasma/serum or urine. In recent years, a number of studies confirmed the diagnostic value of the so-called “Alzheimer’s disease signature” or “Alzheimer’s disease profile” in CSF. Although the frequency of lumbar punctures was traditionally low in Canada and the United States in comparison with northern European countries, clinical research initiatives positively impacted the attitude toward lumbar punctures in recent years and contributed to the implementation of CSF biomarkers in clinical practice and drug development.

For a clinical site performing drug studies in Alzheimer’s disease, it is of great importance to service the requirements needed for performance specialized Alzheimer’s disease studies. The Alzheimer’s patient is part of a very vulnerable population and assuring him or her and their caretaker with optimal care and modern safety requirements during the study has the highest priority. Also, specific assessments need to be established and perfected in the designated clinic, like experienced medical staff for performing lumbar punctures, serial CSF sampling by indwelling catheter, EEG and cognitive testing batteries to name a few. 

Join this free webinar to hear about these new trends in Alzheimer’s disease studies. 

Speakers

Izaak Den Daas, PhD, Director, Patient Studies at QPS Netherlands BV

Izaak Den Daas is an experienced clinical pharmacologist with a demonstrated history of working in the pharmaceuticals and contract research organization (CRO) industry. Izaak brings strong operations professional skills in medical devices, biotechnology, cell culture, research and development and CRO management. His current responsibilities focus on ensuring that the QPS NL (Netherlands) patient clinics are functioning seamlessly, including management and maintenance of the quality system, defining and managing the procurement policies, as well as scientific support by evaluation and design of patient studies. Izaak also supports QPS NL business development in the sponsor acquisition process, identifying the wishes of the sponsor concerning patient studies, gathering and evaluating study feedback, participation in sponsor visits and taking the desired steps for improvement of the quality of patient studies.

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Professor Peter Paul De Deyn, MD, Scientific Director Alzheimer Center Groningen, UMCG Groningen, The Netherlands

Professor Peter Paul De Deyn is a neurologist neuropsychiatrist at the University Medical Center Groningen (UMCG) specializing in preclinical and clinical studies of neurodegenerative disease. Professor De Deyn is the scientific director of the UMCG Alzheimer Center Groningen (ACG). The ACG is a leading knowledge and research center in the field of Alzheimer’s and dementia. The objectives of the ACG are to improve the quality of life of people with dementia and their close relatives and to stimulate scientific research into memory disorders and dementia. In addition, he serves as professor of neurology at the University of Antwerp, practices as a neurologist in the memory clinic, serves as head of the laboratory of neurochemistry and behavior and serves as scientific director at the Institute of Born-Bunge.

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