Deep and Frequent Phenotyping study protocol: an observational study in prodromal Alzheimer's disease.
Thomas, Alan J
Ritchie, Craig W
Thomas, David L
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Koychev, I., Lawson, J., Chessell, T., Mackay, C., Gunn, R., Sahakian, B., Rowe, J., et al. (2019). Deep and Frequent Phenotyping study protocol: an observational study in prodromal Alzheimer's disease.. BMJ open, 9 (3), e024498. https://doi.org/10.1136/bmjopen-2018-024498
Abstract Introduction Recent 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 (for example 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 analysis The 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, PET and CSF markers of pathology, structural MRI markers of neurodegeneration) and experimental modalities (functional MRI, magneto- 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 dissemination The study gained favourable ethical opinion from the South Central - Oxford B NHS Research Ethics Committee (REC reference 17/SC/0315; approved on the 18th of August 2017; amendment 13th of February 2018). Data will be shared with the scientific community no more than one year following completion of study and data assembly.
Humans, Alzheimer Disease, Disease Progression, Magnetic Resonance Imaging, Case-Control Studies, Cognition, Phenotype, Aged, Female, Male, Multicenter Studies as Topic, Amyloid beta-Peptides, Neuroimaging, Biomarkers, Observational Studies as Topic, Positron Emission Tomography Computed Tomography, Mental Status and Dementia Tests, Gait Analysis
MRC (via University of Oxford) (HQR00800)
WELLCOME TRUST (103838/Z/14/Z)
Alzheimer's Research UK (ARUK-PPG2016B-10)
Embargo Lift Date
External DOI: https://doi.org/10.1136/bmjopen-2018-024498
This record's URL: https://www.repository.cam.ac.uk/handle/1810/289224