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Protocol of the cognitive health in ageing register: investigational, observational and trial studies in dementia research (CHARIOT): prospective readiness cOhort (PRO) SubStudy.

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, CT
Watermeyer, T
Price, G
De Jager Loots, CA
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
Lakey, K
Lisa, C
Chowdary Seemulamoodi, Y
Kafetsouli, D
Perera, D
Car, J
Majeed, A
Ward, H
Ritchie, K
Perneczky, R
Kivipelto, M
Scott, D
Bracoud, L
Saad, Z
Novak, G
Ritchie, CW
Middleton, L
Item Type: Journal Article
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 clinicaltrials.gov (NCT02114372). Notices of protocol modifications will be made available through this trial registry.
Issue Date: 24-Jun-2021
Date of Acceptance: 1-Jun-2021
URI: http://hdl.handle.net/10044/1/91510
DOI: 10.1136/bmjopen-2020-043114
ISSN: 2044-6055
Publisher: BMJ Journals
Start Page: 1
End Page: 12
Journal / Book Title: BMJ Open
Volume: 11
Issue: 6
Copyright Statement: © 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. http://creativecommons.org/licenses/by-nc/4.0/ 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: http://creativecommons.org/licenses/by-nc/4.0/.
Sponsor/Funder: Imperial College Healthcare NHS Trust- BRC Funding
National Institute for Health Research
Funder's Grant Number: RDF01
NF-SI-0617-10116
Keywords: Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
epidemiology
dementia
preventive medicine
old age psychiatry
PREVENTION INSTRUMENT PROJECT
ALZHEIMERS-DISEASE
APOLIPOPROTEIN-E
INDIVIDUALS
RELIABILITY
DEFINITION
PREVALENCE
GUIDELINES
BATTERY
DECLINE
dementia
epidemiology
old age psychiatry
preventive medicine
Aged
Aging
Alzheimer Disease
Cognition
Cognitive Dysfunction
Disease Progression
Humans
London
Neuropsychological Tests
Observational Studies as Topic
Prospective Studies
Humans
Alzheimer Disease
Disease Progression
Prospective Studies
Cognition
Neuropsychological Tests
Aging
Aged
London
Observational Studies as Topic
Cognitive Dysfunction
dementia
epidemiology
old age psychiatry
preventive medicine
Aged
Aging
Alzheimer Disease
Cognition
Cognitive Dysfunction
Disease Progression
Humans
London
Neuropsychological Tests
Observational Studies as Topic
Prospective Studies
1103 Clinical Sciences
1117 Public Health and Health Services
1199 Other Medical and Health Sciences
Publication Status: Published
Conference Place: England
Online Publication Date: 2021-06-24
Appears in Collections:Faculty of Medicine
School of Public Health



This item is licensed under a Creative Commons License Creative Commons