Deep and Frequent Phenotyping study protocol: an observational study in prodromal Alzheimer’s disease
| Autor: | Barbara J. Sahakian, David L. Thomas, Alan J. Thomas, Jennifer Lawson, Clare E. Mackay, Vanessa Raymont, Ivan Koychev, Brian D. M. Tom, Roger N. Gunn, Paresh Malhotra, Simon Lovestone, Iain Chessell, James B. Rowe, John Gallacher, Clive Ballard, Matt Murray, Imre Lengyel, Craig W. Ritchie, Iracema Leroi, Tharani Chessell, Lynn Rochester, Dennis Chan |
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| Přispěvatelé: | Koychev, Ivan [0000-0001-6813-8493], Apollo - University of Cambridge Repository |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Male
Pediatrics Disease 0302 clinical medicine Cognition Positron Emission Tomography Computed Tomography Protocol Multicenter Studies as Topic 030212 general & internal medicine tau amyloid alzheimer’s disease General Medicine Alzheimer's disease 16. Peace & justice Mental Status and Dementia Tests Magnetic Resonance Imaging 3. Good health Observational Studies as Topic Mental Health Phenotype Manchester Institute for Collaborative Research on Ageing Disease Progression Female Gait Analysis medicine.medical_specialty prodromal dementia ResearchInstitutes_Networks_Beacons/MICRA Neuroimaging 03 medical and health sciences Alzheimer Disease medicine Dementia Humans Aged Amyloid beta-Peptides business.industry Case-control study Repeated measures design biomarkers medicine.disease Clinical trial Case-Control Studies Observational study business 030217 neurology & neurosurgery |
| Zdroj: | Koychev, I, Lawson, J, Chessell, T, Mackay, C, Gunn, R, Sahakian, B, Rowe, J B, Thomas, A J, Rochester, L, Chan, D, Tom, B, Malhotra, P, Ballard, C, Chessell, I, Ritchie, C W, Raymont, V, Leroi, I, Lengyel, I, Murray, M, Thomas, D, Gallacher, J & Lovestone, S 2019, ' Deep and Frequent Phenotyping study protocol: an observational study in prodromal Alzheimer’s disease ', BMJ Open, vol. 9, no. 3, pp. e024498 . https://doi.org/10.1136/bmjopen-2018-024498 Koychev, I, Lawson, J, Chessell, T, Mackay, C, Gunn, R, Sahakian, B, Rowe, J B, Thomas, A J, Rochester, L, Chan, D, Tom, B, Malhotra, P, Ballard, C, Chessell, I, Ritchie, C W, Raymont, V, Leroi, I, Lengyel, I, Murray, M, Thomas, D L, Gallacher, J & Lovestone, S 2019, ' Deep and Frequent Phenotyping study protocol : An observational study in prodromal Alzheimer's disease ', BMJ Open, vol. 9, no. 3, e024498 . https://doi.org/10.1136/bmjopen-2018-024498 Koychev, I, Lawson, J, Chessell, T, Mackay, C, Gunn, R, Sahakian, B, Rowe, J B, Thomas, A J, Rochester, L, Chan, D, Tom, B, Malhotra, P, Ballard, C, Chessell, I, Ritchie, C W, Raymont, V, Leroi, I, Lengyel, I, Murray, M, Thomas, D L, Gallacher, J & Lovestone, S 2019, ' Deep and Frequent Phenotyping study protocol: an observational study in prodromal Alzheimer's disease ', BMJ Open, vol. 9, no. 3, e024498 . https://doi.org/10.1136/bmjopen-2018-024498 BMJ Open |
| DOI: | 10.1136/bmjopen-2018-024498 |
| Popis: | IntroductionRecent failures of potential novel therapeutics for Alzheimer’s disease (AD) have prompted a drive towards clinical studies in prodromal or preclinical states. However, carrying out clinical trials in early disease stages is extremely challenging—a key reason being the unfeasibility of using classical outcome measures of dementia trials (eg, conversion to dementia) and the lack of validated surrogate measures so early in the disease process. The Deep and Frequent Phenotyping (DFP) study aims to resolve this issue by identifying a set of markers acting as indicators of disease progression in the prodromal phase of disease that could be used as indicative outcome measures in proof-of-concept trials.Methods and analysisThe DFP study is a repeated measures observational study where participants will be recruited through existing parent cohorts, research interested lists/databases, advertisements and memory clinics. Repeated measures of both established (cognition, positron emission tomography (PET) imaging or cerebrospinal fluid (CSF) markers of pathology, structural MRI markers of neurodegeneration) and experimental modalities (functional MRI, magnetoencephalography and/or electroencephalography, gait measurement, ophthalmological and continuous smartphone-based cognitive and other assessments together with experimental CSF, blood, tear and saliva biomarkers) will be performed. We will be recruiting male and female participants aged >60 years with prodromal AD, defined as absence of dementia but with evidence of cognitive impairment together with AD pathology as assessed using PET imaging or CSF biomarkers. Control participants without evidence of AD pathology will be included at a 1:4 ratio.Ethics and disseminationThe study gained favourable ethical opinion from the South Central—Oxford B NHS Research Ethics Committee (REC reference 17/SC/0315; approved on 18 August 2017; amendment 13 February 2018). Data will be shared with the scientific community no more than 1 year following completion of study and data assembly. |
| Databáze: | OpenAIRE |
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