Affiliations: [a] Innovation Center for Neurological Disorders and Department of Neurology, Xuanwu Hospital, Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, People’s Republic of China | [b]
National Clinical Research Center for Geriatric Diseases, Beijing, People’s Republic of China | [c] Clinical Center for Neurodegenerative Disease and Memory Impairment, Capital Medical University, Beijing, People’s Republic of China | [d] Center of Alzheimer’s Disease, Beijing Institute for Brain Disorders, Beijing, People’s Republic of China
Correspondence:
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Correspondence to: Jianping Jia, MD, PhD, Innovation Center for Neurological Disorders, Department of Neurology, Xuanwu Hospital, Capital Medical University, 45 Changchun Street, Beijing, China. Tel.: +86 10 83199449; Fax: +86 10 83171070; E-mail: E-mail: jiajp@vip.126.com.
Abstract: Alzheimer’s disease (AD) research is entering a unique moment in which enormous information about the molecular basis of this disease is being translated into therapeutics. However, almost all drug candidates have failed in clinical trials over the past 30 years. These many trial failures have highlighted a need for the incorporation of biomarkers in clinical trials to help improve the trial design. Fluid biomarkers measured in cerebrospinal fluid and circulating blood, which can reflect the pathophysiological process in the brain, are becoming increasingly important in AD clinical trials. In this review, we first succinctly outline a panel of fluid biomarkers for neuropathological changes in AD. Then, we provide a comprehensive overview of current and future application of fluid biomarkers in clinical trials for AD. We also summarize the many challenges that have been encountered in efforts to integrate fluid biomarkers in clinical trials, and the barriers that have begun to be overcome. Ongoing research efforts in the field of fluid biomarkers will be critical to make significant progress in ultimately unveiling disease-modifying therapies in AD.
