Protocol of the Cognitive Health in Ageing Register: Investigational, Observational and Trial Studies in Dementia Research (CHARIOT): Prospective Readiness cOhort (PRO) SubStudy

Chinedu T. Udeh-Momoh, Tamlyn Watermeyer, Geraint Price, Celeste A. de Jager Loots, Natalia Reglinska-Matveyev, Michael Ropacki, Nzeera Ketter, Michael Fogle, Nandini Raghavan, Michael Arrighi, Robert Brashear, Jianing Di, Susan Baker, Parthenia Giannakopoulou, Catherine Robb, Darina Bassil, Martin Cohn, Heather McLellan-Young, Jennifier Crispin, Kristina LakeyCurry Lisa, Yellappa Chowdary Seemulamoodi, Dimitra Kafetsouli, Dinithi Perera, Josip Car, Azeem Majeed, Heather Ward, Karen Ritchie, Robert Perneczky, Miia Kivipelto, David Scott, Luc Bracoud, Ziad Saad, Gerald Novak, Craig W Ritchie, Lefkos Middleton

Research output: Contribution to journalArticlepeer-review

Abstract

The Cognitive Health in Ageing Register: Investigational, Observational and Trial Studies in Dementia Research (CHARIOT): Prospective Readiness cOhort (PRO) SubStudy (CPSS), sponsored by Janssen Pharmaceutical Research & Development LLC, is an Alzheimer's disease (AD) biomarker enriched observational study that began 3 July 2015 CPSS aims to identify and validate determinants of AD, alongside cognitive, functional and biological changes in older adults with or without detectable evidence of AD pathology at baseline. CPSS is a dual-site longitudinal cohort (3.5 years) assessed quarterly. Cognitively normal participants (60-85 years) were recruited across Greater London and Edinburgh. Participants are classified as high, medium (amnestic or non-amnestic) or low risk for developing mild cognitive impairment-Alzheimer's disease based on their Repeatable Battery for the Assessment of Neuropsychological Status performance at screening. Additional AD-related assessments include: a novel cognitive composite, the Global Preclinical Alzheimer's Cognitive Composite, brain MRI and positron emission tomography and cerebrospinal fluid analysis. Lifestyle, other cognitive and functional data, as well as biosamples (blood, urine, and saliva) are collected. Primarily, study analyses will evaluate longitudinal change in cognitive and functional outcomes. Annual interim analyses for descriptive data occur throughout the course of the study, although inferential statistics are conducted as required. CPSS received ethical approvals from the London-Central Research Ethics Committee (15/LO/0711) and the Administration of Radioactive Substances Advisory Committee (RPC 630/3764/33110) The study is at the forefront of global AD prevention efforts, with frequent and robust sampling of the well-characterised cohort, allowing for detection of incipient pathophysiological, cognitive and functional changes that could inform therapeutic strategies to prevent and/or delay cognitive impairment and dementia. Dissemination of results will target the scientific community, research participants, volunteer community, public, industry, regulatory authorities and policymakers. On study completion, and following a predetermined embargo period, CPSS data are planned to be made accessible for analysis to facilitate further research into the determinants of AD pathology, onset of symptomatology and progression. The CHARIOT:PRO SubStudy is registered with clinicaltrials.gov (NCT02114372). Notices of protocol modifications will be made available through this trial registry. [Abstract copyright: © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.]
Original languageEnglish
Article numbere043114
Number of pages12
JournalBMJ Open
Volume11
Issue number6
Early online date24 Jun 2021
DOIs
Publication statusPublished - 24 Jun 2021

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