OTAPA: Optimising Trial Design to Achieve Personalised prevention of Alzheimer’s disease

Alzheimer’s disease is among the largest health care challenges. Former clinical trials have taught important lessons: (i) the stage of dementia is too late to ‘undo’ brain damage. Clinical trials should focus on the stages before dementia. (ii) AD is a complex disease. This implies that there will never be one silver bullet that is effective treatment for all. We should focus on personalized treatment. The aim of OTAPA was to develop recommendations to improve the design of clinical trials.

In collaboration with the Brain Research Center we asked participants of clinical trials for their motivation to participate and their experiences. In addition, we have combined existing data-sets of clinical trials with the ambition to re-analyse them. En important challenge was that these data-sets were not easily accessible, and that there were large differences between data types hampering pooling of data. We wrote an article calling on pharmaceutical companies to make their data more easily accessible and harmonize data collection. Using proteomics analysis of the cerebrospinal fluid, we identified five molecular subtypes of AD. In the SCIENCe cohort, an observational study in cognitively normal individuals at risk of AD dementia, we found that the currently used cognitive tasks are sensitive enough to show decline over time, but only when participants are followed for a sufficiently long period of time.

Based on these findings, we formulated recommendations for clinical trials in AD.

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