Brief ReportsPrimary Endpoints in Current Phase II/III Trials for Alzheimer Disease A Systematic Survey of Trials Registered at ClinicalTrials.govTakeshima, Nozomi MD, PhD*; Ishiwata, Keita BE†; Sozu, Takashi PhD‡; Furukawa, Toshi A. MD, PhD*Author Information *Department of Health Promotion of Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Yoshida Konoe-cho, Sakyo-ku, Kyoto †Department of Management Science ‡Department of Information and Computer Technology, Faculty of Engineering, Tokyo University of Science, Tokyo, Japan N.T. has received lecture fees from Otsuka and Meiji. T.A.F. has received lecture fees from Eli Lilly, Janssen, Meiji, MSD, Otsuka, Pfizer and Mitsubishi-Tanabe, and consultancy fees from Takeda Science Foundation. The remaining authors declare no conflicts of interest. Reprints: Nozomi Takeshima, MD, PhD, Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Yoshida Konoe-cho, Sakyo-ku, Kyoto 606-8501, Japan (e-mail: firstname.lastname@example.org). Alzheimer Disease & Associated Disorders: January–March 2020 - Volume 34 - Issue 1 - p 97-100 doi: 10.1097/WAD.0000000000000297 Buy Metrics Abstract This study examined the primary and secondary endpoints used by recent phase II/III randomized controlled trials (RCTs) of drugs for the Alzheimer disease. We searched the Clinical Trials.gov database to identify all RCTs registered from January 1, 2011 until August 19, 2018. We identified 122 RCTs and examined primary and secondary endpoints most commonly used. The median number of primary endpoints was 1 (range: 1 to 48) and the median number of secondary endpoints was 4 (range: 1 to 19). Cognitive function was used as a primary endpoint by 59% of the RCTs identified. Although few trials included a primary outcome set that fulfilled the US Food and Drug Administration (FDA) or European Committee for Medicinal Products for Human Use (CHMP) requirements, these were met by a combination of the primary and secondary outcomes of more than half of the trials. Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.