Regulatory considerations for developing remote measurement technologies for Alzheimer's disease research

Abstract

The Remote Assessment of Disease and Relapse – Alzheimer’s Disease (RADAR-AD) consortium evaluated remote measurement technologies (RMTs) for assessing functional status in AD. The consortium engaged with the European Medicines Agency (EMA) to obtain feedback on identification of meaningful functional domains, selection of RMTs and clinical study design to assess the feasibility of using RMTs in AD clinical studies. We summarized the feedback and the lessons learned to guide future projects.

Fig. 1. Concept of Interest Derived from a Meaningful Aspect of Health (Activities of Daily Living).

Health experiences (a) reported by the Patient Advisory Board (PAB) were mapped onto the functional domains (b) that were then operationalized (c). For example, the functional domain ‘Managing finances’ was assessed with an App mimicking the withdrawal of money. Operationalizations of this functional domain are then subdivided into measurable elements such as the total duration of an attempt to withdraw money, the duration to enter the correct PIN code, or the duration of entering the correct amount of money to be withdrawn. These ultimately translate into a Concept of Interest (CoI).

Fig. 2. Qualification advice process and timelines.

Overall, the advice period lasted 7 months, which was preceded by the compilation of the briefing book (5 months). Validation comments from the European Medicines Agency (EMA) were received 3 months after submission. After submitting a revised version of the briefing book, the consortium received a list of issues that were addressed in a written response as well as an online meeting. The final Qualification Advice was received 7 months after the briefing book submission. Submissions by the consortium are shown in blue, CHMP responses in brown and meetings in green.