Digital endpoints in clinical trials of Alzheimer's disease and other neurodegenerative diseases: challenges and opportunities.

Brem, Anna-Katharine; Kuruppu, Sajini; de Boer, Casper; Muurling, Marijn; Diaz-Ponce, Ana; Gove, Dianne; Curcic, Jelena; Pilotto, Andrea; Ng, Wan-Fai; Cummins, Nicholas; Malzbender, Kristina; Nies, Vera J M; Erdemli, Gul; Graeber, Johanna; Narayan, Vaibhav A; Rochester, Lynn; Maetzler, Walter; Aarsland, Dag (2023). Digital endpoints in clinical trials of Alzheimer's disease and other neurodegenerative diseases: challenges and opportunities. Frontiers in neurology, 14, p. 1210974. Frontiers Media S.A. 10.3389/fneur.2023.1210974

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Alzheimer's disease (AD) and other neurodegenerative diseases such as Parkinson's disease (PD) and Huntington's disease (HD) are associated with progressive cognitive, motor, affective and consequently functional decline considerably affecting Activities of Daily Living (ADL) and quality of life. 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 in clinical trials. Major advances in the last decade in digital technologies have opened a window of opportunity to introduce digital endpoints into clinical trials that can reform the assessment and tracking of neurodegenerative symptoms. The Innovative Health Initiative (IMI)-funded projects RADAR-AD (Remote assessment of disease and relapse-Alzheimer's disease), IDEA-FAST (Identifying digital endpoints to assess fatigue, sleep and ADL in neurodegenerative disorders and immune-mediated inflammatory diseases) and Mobilise-D (Connecting digital mobility assessment to clinical outcomes for regulatory and clinical endorsement) aim to identify digital endpoints relevant for neurodegenerative diseases that provide reliable, objective, and sensitive evaluation of disability and health-related quality of life. In this article, we will draw from the findings and experiences of the different IMI projects in discussing (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; and (6) the significance of inter-project exchange and data- and algorithm-sharing.

Item Type:

Journal Article (Review Article)


04 Faculty of Medicine > University Psychiatric Services > University Hospital of Geriatric Psychiatry and Psychotherapy

UniBE Contributor:

Brem, Anna- Katharine


600 Technology > 610 Medicine & health




Frontiers Media S.A.




Pubmed Import

Date Deposited:

13 Jul 2023 07:42

Last Modified:

16 Jul 2023 02:27

Publisher DOI:


PubMed ID:


Uncontrolled Keywords:

Alzheimer’s disease Huntington’s disease Parkinson’s disease dementia digital biomarker digital health technologies neurodegenerative diseases remote measurement technologies




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