Dementias Platform UK Clinical Studies and Great Minds register: Protocol of a targeted brain health studies re-contact database

Abstract

Introduction: The case for de-risking neurodegenerative research and development through highly informative experimental medicine studies early in the disease process is strong. Such studies depend on the availability of genetic as well as high-granularity, longitudinal, phenotypic data in healthy aging individuals who can be recruited into early phase trials on the basis of their perceived dementia risk. Until now the creation of such research infrastructure has been hampered by the lack of expense and time required to gather the rich longitudinal data needed for adequate risk stratification. Dementias Platform UK (DPUK) is a public-private partnership that brings together data from over 40 cohorts in a standardised framework, which represents an until now unavailable opportunity to create such a resource through a streamlined brain health re-contact platform based on existing cohorts, as well as prospectively collected data. Methods and analysis: The DPUK re-contact platform consists of an opt-in (Great Minds, GM) and an opt-out component (Clinical Studies register, CSR). GM requires invited DPUK cohort participants to consent to targeted re-contact at the GM website and then to provide self-reported demographic and medical history information relevant to recruitment into clinical studies. Participants complete prospective browser- and smartphone-based cognitive tests and are given the option for remote genetic and actigraphy testing. The GM data is linked to the retrospective DPUK cohort dataset, including genotypic and longitudinal phenotypic data. The CSR is a solution for cohorts explicitly allowing targeted re-contact. Approved studies provide pre-screening criteria on the basis of the CSR/GM dataset, and individuals meeting these criteria are offered participation directly (GM) or through the parent DPUK cohort (CSR). Descriptive statistics will be used to summarise the outcomes relevant to the number of participants engaged with the register. Its sample size is not defined but is limited by the size of the DPUK parent cohorts. Ethics and dissemination: The database was approved by the South Central - Oxford C Research Ethics Committee, reference 18/SC/0268 on the 27th of June 2018 and amended on the 1st of November 2019. The availability of the Register to researchers will be disseminated through DPUK official communication channels as well as national and international scientific meetings.