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Title: Protocol of the cognitive health in ageing register : investigational, observational and trial studies in dementia research (CHARIOT) : prospective readiness cOhort (PRO) SubStudy
Authors: Udeh-Momoh, Chinedu T.
Watermeyer, Tamlyn
Price, Geraint
de Jager Loots, Celeste A.
Reglinska-Matveyev, Natalia
Ropacki, Michael
Ketter, Nzeera
Fogle, Michael
Raghavan, Nandini
Arrighi, Michael
Brashear, Robert
Di, Jianing
Baker, Susan
Giannakopoulou, Parthenia
Robb, Catherine
Bassil, Darina
Cohn, Martin
McLellan-Young, Heather
Crispin, Jennifier
Lakey, Kristina
Lisa, Curry
Chowdary Seemulamoodi, Yellappa
Kafetsouli, Dimitra
Perera, Dinithi
Car, Josip
Majeed, Azeem
Ward, Heather
Ritchie, Karen
Perneczky, Robert
Kivipelto, Miia
Scott, David
Bracoud, Luc
Saad, Ziad
Novak, Gerald
Ritchie, Craig W.
Middleton, Lefkos
Keywords: Science::Medicine
Issue Date: 2021
Source: Udeh-Momoh, C. T., Watermeyer, T., Price, G., de Jager Loots, C. A., Reglinska-Matveyev, N., Ropacki, M., Ketter, N., Fogle, M., Raghavan, N., Arrighi, M., Brashear, R., Di, J., Baker, S., Giannakopoulou, P., Robb, C., Bassil, D., Cohn, M., McLellan-Young, H., Crispin, J., ...Middleton, L. (2021). Protocol of the cognitive health in ageing register : investigational, observational and trial studies in dementia research (CHARIOT) : prospective readiness cOhort (PRO) SubStudy. BMJ Open, 11(6), e043114-.
Journal: BMJ Open
Abstract: Introduction 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. Methods and analysis 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. Ethics and dissemination 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. Trial registration number The CHARIOT:PRO SubStudy is registered with (NCT02114372). Notices of protocol modifications will be made available through this trial registry.
ISSN: 2044-6055
DOI: 10.1136/bmjopen-2020-043114
Rights: © 2021 The Author(s) (or their employer(s)). Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:
Fulltext Permission: open
Fulltext Availability: With Fulltext
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