Journal article
New Therapeutics in Alzheimer’s Disease longitudinal cohort study (NTAD): study protocol
- Abstract:
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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.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Version of record, pdf, 2.1MB, Terms of use)
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- Publisher copy:
- 10.1136/bmjopen-2021-055135
Authors
- Funder identifier:
- https://ror.org/029chgv08
- Grant:
- 104571/Z/14/Z
- Publisher:
- BMJ Publishing Group
- Journal:
- BMJ Open More from this journal
- Volume:
- 12
- Issue:
- 12
- Article number:
- e055135
- Publication date:
- 2022-12-15
- Acceptance date:
- 2022-11-01
- DOI:
- EISSN:
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2044-6055
- ISSN:
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2044-6055
- Language:
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English
- Keywords:
- Pubs id:
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1315378
- Local pid:
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pubs:1315378
- Deposit date:
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2022-12-16
- ARK identifier:
Terms of use
- Copyright holder:
- Lanskey et al.
- Copyright date:
- 2022
- Rights statement:
- © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
- Notes:
- This work is related to the thesis Synaptic health in Alzheimer’s Disease: exploring MEG, MRI, and neuropathology.
- Licence:
- CC Attribution (CC BY)
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