Standard assessments, such as questionnaires and interviews, cognitive testing, and mobility assessments, lack sensitivity, especially in early stages of neurodegenerative diseases and in the disease progression, and have therefore a limited utility as outcome measurements. Digital technologies have great potential for research and clinical use in Alzheimer’s disease. They offer a unique opportunity to identify, assess and track cognition and everyday function over time.
Mission and vision
- We ultimately aim to transform patient care through remote assessment
- If the technology validation is successful, we want to develop a path to formally define – based on solid device data - outcome measures in assessing therapeutic interventions in AD
- This must be done in close collaboration with regulatory authorities and patients
Previous publications
Previous RADAR-AD publications describe the design of the project, selection of suitable RMTs, feasibility and usability, public involvement activities and ethical challenges. First results have been published on specific RMTs, such as augmented reality and physiological measures. For an overview of publications to date, please view this list on RADAR-AD.
The videos on the RADAR-AD website provide further insight into the research, preliminary results and participant experiences within the project.
Importance of regulatory involvement when evaluating digital technologies
For research results to be translated from bench to bedside, early regulatory involvement is key. In collaboration with other IMI-funded consortia (Mobilise-D and IDEA-FAST) we undertook a mini review, published in Frontiers in Neurology, in which we discussed the experiences of the different consortia that are relevant for the development of digital endpoints in clinical trials.
The digital endpoints from the trials include:
- (1) the value of remote technologies to assess neurodegenerative diseases
- (2) feasibility, acceptability and usability of digital assessments
- (3) challenges related to the use of digital tools
- (4) public involvement and the implementation of patient advisory boards
- (5) regulatory learnings
- (6) the significance of inter-project exchange and data- and algorithm-sharing
From December 2022 to July 2023, 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. This process has recently been published in npj Digital Medicine.
EMA key considerations
The Committee for Medicinal Products for Human Use (CHMP) agreed with the process that RADAR-AD adopted for RMT selection and identification of functional domains reflecting meaningful aspects of AD. Longitudinal research will be necessary to evaluate whether the identified functional domains are indicative of different stages of AD, starting from the very early stages, and can be implemented to predict, or monitor disease progression.
Future of RADAR-AD
Further RADAR-AD results are expected to be published in the near future, which include in-depth analyses of cognition, motor, speech and sleep related measures. Combining different digital measures, we are currently developing a multimodal digital biomarker of functional deficits in early Alzheimer’s disease. In a viewpoint, we will moreover discuss ethical issues related to digital biomarker research.