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New Therapeutics in Alzheimer's Disease Longitudinal Cohort study (NTAD): study protocol.

Published version
Peer-reviewed

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Authors

Lanskey, Juliette Helene  ORCID logo  https://orcid.org/0000-0002-6626-7686
Cheng, Yun-Ju 
Karadag, Melek 

Abstract

INTRODUCTION: With the pressing need to develop treatments that slow or stop the progression of Alzheimer's disease, new tools are needed to reduce clinical trial duration and validate new targets for human therapeutics. Such tools could be derived from neurophysiological measurements of disease. METHODS AND ANALYSIS: The New Therapeutics in Alzheimer's Disease study (NTAD) aims to identify a biomarker set from magneto/electroencephalography that is sensitive to disease and progression over 1 year. The study will recruit 100 people with amyloid-positive mild cognitive impairment or early-stage Alzheimer's disease and 30 healthy controls aged between 50 and 85 years. Measurements of the clinical, cognitive and imaging data (magnetoencephalography, electroencephalography and MRI) of all participants will be taken at baseline. These measurements will be repeated after approximately 1 year on participants with Alzheimer's disease or mild cognitive impairment, and clinical and cognitive assessment of these participants will be repeated again after approximately 2 years. To assess reliability of magneto/electroencephalographic changes, a subset of 30 participants with mild cognitive impairment or early-stage Alzheimer's disease will also undergo repeat magneto/electroencephalography 2 weeks after baseline. Baseline and longitudinal changes in neurophysiology are the primary analyses of interest. Additional outputs will include atrophy and cognitive change and estimated numbers needed to treat each arm of simulated clinical trials of a future disease-modifying therapy. ETHICS AND DATA STATEMENT: The study has received a favourable opinion from the East of England Cambridge Central Research Ethics Committee (REC reference 18/EE/0042). Results will be disseminated through internal reports, peer-reviewed scientific journals, conference presentations, website publication, submission to regulatory authorities and other publications. Data will be made available via the Dementias Platform UK Data Portal on completion of initial analyses by the NTAD study group.

Description

Peer reviewed: True

Keywords

Dementia, NEUROLOGY, NEUROPHYSIOLOGY, Neurophysiology, Protocols & guidelines, RADIOLOGY & IMAGING, Humans, Middle Aged, Aged, Aged, 80 and over, Alzheimer Disease, Longitudinal Studies, Reproducibility of Results, Disease Progression, Cognitive Dysfunction, Cohort Studies

Journal Title

BMJ Open

Conference Name

Journal ISSN

2044-6055
2044-6055

Volume Title

Publisher

BMJ
Sponsorship
Medical Research Council (MR/L023784/1)
Medical Research Council (MR/L023784/2)
Alzheimer's Research UK (ARUK-PG2017B-19)
Medical Research Council (MC_UU_00005/12)
Medical Research Council (MC_UU_00005/8)
National Institute for Health and Care Research (IS-BRC-1215-20014)
Wellcome Trust (103838/Z/14/Z)
MRC (via University of Oxford) (MR/T033371/1)
MRC (MC_UU_00030/8)
This work is part of the Dementias Platform UK (MR/L023784/1 & MR/L023784/2) which is funded by the Medical Research Council, Janssen, AstraZeneca, Araclon, IXICO, Somalogic, GlaxoSmithKline, Invicro, Cambridge Cognition and Cognetivity. The study has additional support from Alzheimer’s Research UK (ARUK-PG2017B-19), the Wellcome Trust (103838), Medical Research Council (SUAG/051 G101400; SUAG/046 G101400), NIHR Cambridge Biomedical Research Centre (BRC-1215-20014) and NIHR Oxford Biomedical Research Centre (BRC-1215-20008). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. For the purpose of Open Access, the author has applied a CC BY public copyright licence to any Author Accepted Manuscript version arising from this submission.
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