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Identification of biomarkers for pre-clinical or very early disease for use in experimental medicine is the key challenge to be overcome for the successful and effective delivery of clinical trials in AD. The MRC/NIHR funded 'deep and frequent phenotyping study' is embedded in the Dementias Platform UK and will combine established markers, such as PET amyloid imaging and structural MRI, with novel markers, such as PET tau imaging and retinal imaging; and include potential markers which are not yet fully validated in this population, such as electrophysiology and peripheral molecular markers. These potential markers will be evaluated alone and together with conventional assessments of clinical and cognitive change, allowing the development of a multi-modal marker set for measurement of change and its prevention or modification in AD.

The feasibility study is in progress using the infrastructure for experimental medicine established in the UK by the NIHR Translational Research Collaboration for Dementia (TRC-D). We will establish whether it is practicable to do very frequent phenotyping in this population; whether such deep and frequent phenotyping is acceptable to participants; and whether protocols, trial governance and process arrangements be established that would allow clinical trials to proceed within a reasonable time frame and cost.