title: Global Trends in Alzheimer Disease Clinical Development: Increasing the Probability of Success.
abstract: OBJECTIVE
  Alzheimer disease (AD) is a growing global health and economic issue as elderly populations increase dramatically across the world. Despite the many clinical trials conducted, currently no approved disease-modifying treatment exists. In this commentary, the present status of AD drug development and the grounds for collaborations between government, academia, and industry to accelerate the development of disease-modifying AD therapies are discussed.
  
  
  METHODS
  Official government documents, literature, and news releases were surveyed by MEDLINE and website research.
  
  
  RESULTS
  Currently approved anti-AD drugs provide only short-lived symptomatic improvements, which have no effect on the underlying pathogenic mechanisms or progression of the disease. The failure to approve a disease-modifying drug for AD may be because the progression of AD in the patient populations enrolled in clinical studies was too advanced for drugs to demonstrate cognitive and functional improvements. The US Food and Drug Administration and the European Medicines Agency recently published draft guidance for industry which discusses approaches for conducting clinical studies with patients in early AD stages. For successful clinical trials in early-stage AD, however, it will be necessary to identify biomarkers highly correlated with the clinical onset and the longitudinal progress of AD. In addition, because of the high cost and length of clinical AD studies, support in the form of global initiatives and collaborations between government, industry, and academia is needed.
  
  
  CONCLUSIONS
  In response to this situation, national guidance and international collaborations have been established. Global initiatives are focusing on 2025 as a goal to provide new treatment options, and early signs of success in biomarker and drug development are already emerging.
authors.affiliation: Global CNS Business, Otsuka Pharmaceutical Development and Commercialization, Ltd (OPDC), Princeton, New Jersey. Electronic address: suginoh@otsuka.jp.
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Sugino
authors.affiliation: Global Pharmaceutical Business, Otsuka Pharmaceutical Co Ltd, Tokyo, Japan.
authors.forename: Akihito
authors.initials: A
authors.lastname: Watanabe
authors.affiliation: Qs' Research Institute, Otsuka Pharmaceutical Co Ltd, Tokushima, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Amada
authors.affiliation: Global Pharmaceutical Business, Otsuka Pharmaceutical Co Ltd, Tokyo, Japan.
authors.forename: Miho
authors.initials: M
authors.lastname: Yamamoto
authors.affiliation: Qs' Research Institute, Otsuka Pharmaceutical Co Ltd, Tokushima, Japan.
authors.forename: Yuta
authors.initials: Y
authors.lastname: Ohgi
authors.affiliation: Global Medical Affairs, OPDC, Princeton, NJ.
authors.forename: Dusan
authors.initials: D
authors.lastname: Kostic
authors.affiliation: Global Clinical Development, OPDC, USA, Princeton, New Jersey.
authors.forename: Raymond
authors.initials: R
authors.lastname: Sanchez
mesh_terms: D000544:Alzheimer Disease / Q000097:blood / Q000188:drug therapy* / Q000517:prevention & control; D015415:Biomarkers / Q000097:blood; D002986:Clinical Trials as Topic; D017277:Drug Approval; D014943:Global Health; D006801:Humans; D018696:Neuroprotective Agents / Q000627:therapeutic use; D018697:Nootropic Agents / Q000627:therapeutic use; D012107:Research Design
chemical_list: D015415:Biomarkers; D018696:Neuroprotective Agents; D018697:Nootropic Agents
keywords: Alzheimer disease (AD); biomarker; drug development; early stage; mild cognitive impairment (MCI)