Building on the strength of data provided by DPUK, the clinical studies register will provide a critical link to much-needed studies and trials to better understand the disease and potential treatments.
Although dementia is the disorder with the greatest unmet need, over the last 20 years there has been a near 100% failure in the development of new treatments. While many reasons underlie this failure, they centre on an inability to recruit well characterised individuals – such as those from cohorts. We know so much more about cohort volunteers than the general public which make them idea subjects for experimental medicine programmes and early phase trials.
To make possible a new generation of highly targeted clinical studies, DPUK is establishing a clinical studies register of highly characterised individuals from cohort studies. It will provide increased academic opportunity and renewed pharma interest in developing new dementia therapies.
How it will work
The three key design elements of the register are:
- Providing fine-grained risk stratification: Although most studies will need to access individuals at increased risk of dementia, for comparison, access to low risk individuals will also be required. Of greatest interest are individuals with brain imaging, particularly if the brain imaging has been repeated. However, individuals with existing cognitive data are also highly informative.
- Access to existing data: The register will access from cohorts a limited number of variables relevant to dementia risk. These will include age and family history of disease (including dementia), selected genetic information, selected lifestyle data (exercise, smoking, and alcohol), MRI scans, mood and cognition. These will be used to inform risk stratification algorithms and implement inclusion and exclusion criteria for proposed clinical studies.
- Web- and smartphone- based enhancement of existing data: The value of the register for studies lies in its ability to characterise early disease status and progression which can be highly variable. Register participants take six-monthly online repeat assessments of cognition, mood and everyday functioning which captures individual trajectories This data will be made available to cohorts.