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Name RADAR-AD
Long Name Remote assessment of disease and relapse – Alzheimer’s disease
Description Remote assessment of disease and relapse – Alzheimer’s disease. People in the earliest stages of Alzheimer’s disease experience declining cognitive and functional abilities, making it harder for them to remember things and places, carry out simple calculations, use a phone/computer, drive, and adhere to medications. The goal of the RADAR-AD platform is to develop a digital platform that would draw on smartphone, wearable and home-based digital technologies to track subtle changes in the cognitive and functional abilities of people with Alzheimer’s disease. The project will adapt the existing RADAR-CNS project’s platform for Alzheimer’s disease. Among other things, the team will have to take account of the fact that many people with Alzheimer’s disease are older and so may be less familiar with technology, while their condition may make it more difficult for them to learn to handle technological devices. People with Alzheimer’s disease will be fundamentally involved in the design and development of the project so that the systems put in place are acceptable and appropriate for them. The platform will be tested in a clinical study with people with different stages of Alzheimer’s disease. Ultimately, the project results will make it easier to assess how well new dementia treatments work.
Objectives 1. Define meaningful and disease-relevant functional domains that are likely to be specific and sensitive to early stages of Alzheimer’s progression and predictive of deleterious long-term outcomes such as loss of independence and nursing home entry. 2. Prioritise pre-existing wearable/home-based sensors and devices and computerised functional tasks based on existing literature, discussions with patient/caregivers and regulators, and our own piloting, and linking these to the available RADAR-CNS platform. 3. Model functional and cognitive decline using data from available longitudinal cohorts. 4. Validate the platform technology-enabled function assessment system in a real world clinical setting, i.e. an observational clinical study, with a 3 months baseline assessment of function to establish a reliable cross-sectional measure of function using the built sensor-based system in a cohort covering the full spectrum from normal cognition through mild cognitive impairment (MCI), mild AD and moderate and severe AD 5. If validation is successful, work with regulatory agencies to develop a path to define formally outcome measures in assessing therapeutic interventions in AD.
Website http://www.radar-ad.org/
Start date 01-01-2019
End date 30-06-2023
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Name Projects Type of institution Country  
Janssen Pharmaceutica NV EPAD ADAPTED AMYPAD IMPRiND EQIPD NEURONET EMIF IM2PACT PHAGO PRISM RADAR-CNS RADAR-AD ROADMAP IDEA-FAST Pharma-Cog EPND EFPIA Belgium
Alzheimer Europe EPAD AMYPAD MOPEAD AETIONOMY EMIF RADAR-AD ROADMAP NEURONET Pharma-Cog EPND Patient/carers organisation Luxembourg
Eli Lilly And Company Ltd EPAD IMPRiND MOPEAD PHAGO PRISM RADAR-AD ROADMAP NEURONET IDEA-FAST Pharma-Cog EFPIA United Kingdom
Novartis Pharma AG EPAD IMPRiND EQIPD AETIONOMY IM2PACT PRISM RADAR-AD ROADMAP Mobilise-D Pharma-Cog EPND EFPIA Switzerland
Karolinska Institutet EPAD AMYPAD MOPEAD AETIONOMY EMIF RADAR-AD Academia Sweden
King's College London PHAGO RADAR-CNS RADAR-AD EMIF PD-MIND EPND Academia United Kingdom
Agentschap College Ter Beoordeling Van Geneesmiddelen RADAR-AD ROADMAP EPND Academia Netherlands
Fraunhofer Gesellschaft Zur Foerderung Der Angewandten Forschung EV EPAD AETIONOMY PHAGO RADAR-AD Academia Germany
University Of Oxford EPAD IMPRiND IM2PACT RADAR-AD ROADMAP EMIF EPND Academia United Kingdom
VU University Medical Center Amsterdam EPAD AMYPAD IM2PACT PRISM MOPEAD RADAR-CNS RADAR-AD EMIF PRISM2 Pharma-Cog EPND Academia Netherlands
Lygature RADAR-CNS RADAR-AD PD-MIND EPND SME Netherlands
Altoida AG RADAR-AD SME Switzerland
Software AG RADAR-CNS RADAR-AD SME Germany
The Hyve BV RADAR-CNS RADAR-AD Other Netherlands
Ethniko Kentro Erevnas Kai Technologikis Anaptyxis RADAR-AD Academia Greece
Takeda Pharmaceuticals International AG EPND EPAD PRISM RADAR-AD ROADMAP IDEA-FAST Mobilise-D NEURONET EFPIA Switzerland
WP number Description Project  
WP1 Project Management RADAR-AD
WP2 Identification of clinical functional domains relevant to early AD progression RADAR-AD
WP3 Interaction with regulatory authorities and patient associations RADAR-AD
WP4 Development of a technology-enabled platform RADAR-AD
WP5 Clinical validation of technology-enabled functional assessment RADAR-AD
WP6 Communication and dissemination RADAR-AD
Deliverable number Title Project Submission date Link Keywords  
D3.1 First meeting standing patient advisory group RADAR-AD 31-01-2020 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5cc763dcc&appId=PPGMS
D6.2 Launch of website RADAR-AD 31-03-2019 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5c3822120&appId=PPGMS
D6.3 Generic press release to be used by all partners RADAR-AD 03-05-2019 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5c43d838a&appId=PPGMS
D2.1 Preliminary Prioritized list of functional domains RADAR-AD 31-03-2019 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5c382145e&appId=PPGMS
D3.5 Focus group report on ADLs that can be monitored with RMT RADAR-AD 26-08-2019 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5c72758cf&appId=PPGMS
D1.2 Report on Kick-off meeting RADAR-AD 30-06-2019 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5c5601be8&appId=PPGMS
D5.1 Research Protocol RADAR-AD 04-07-2019 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5c5c8e86d&appId=PPGMS
D6.1 Develop visual identity and communication strategy RADAR-AD 31-03-2019 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5c382162f&appId=PPGMS
D4.3 Integration of additional data sources and report detailing setup and on-boarding process for each device integrated with the platform RADAR-AD 03-02-2020 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5cc763f56&appId=PPGMS
D4.4 Customized platform and test plan for WP5 study RADAR-AD 03-02-2020 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5cc763dd2&appId=PPGMS
D4.6 Pre-study-start release of deployable Plug-in components RADAR-AD 13-11-2020 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5cc41f240&appId=PPGMS
D2.4 Generation of the overview on the variables, cohort selection and intermediate statistical modeling RADAR-AD 16-01-2020 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5cbb28351&appId=PPGMS
D3.4 Focus group report on AD patients as vulnerable population, stigma and misuse of RMT RADAR-AD 18-01-2020 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5cc41c4d7&appId=PPGMS
D1.8 Draft version of Data Management Plan RADAR-AD 31-07-2019 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5c7d2938f&appId=PPGMS
D2.3 Identification and evaluation of Longitudinal Cohorts RADAR-AD 14-01-2020 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5cbb28286&appId=PPGMS
D3.7 Report on insights from patient and caregiver interviews on moral beliefs RADAR-AD 20-07-2020 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5d2259cb6&appId=PPGMS
D5.2 Updated version of research protocol RADAR-AD 03-02-2020 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5cca450bc&appId=PPGMS
D4.8 Installed and tested live RADAR-AD environment for use by WP5 RADAR-AD 13-11-2020 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5cc41e44d&appId=PPGMS
D4.1 Device Selection Report RADAR-AD 29-03-2021 https://www.radar-ad.org/sites/radarad/files/2021-02/RADAR-AD%20device%20selection%20report.pdf
D1.9 First update of Data Management Plan RADAR-AD 29-03-2021 https://www.radar-ad.org/sites/radarad/files/2021-02/First%20update%20of%20Data%20Management%20Plan.pdf
D3.10 First meeting report of the standing regulatory and policy advisory group RADAR-AD 29-03-2021 https://www.radar-ad.org/sites/radarad/files/2021-02/First%20meeting%20report%20of%20the%20standing%20regulatory%20and%20policy%20advisory%20group.pdf
D2.2 Manuscript describing functional domains RADAR-AD 29-03-2021 https://www.radar-ad.org/sites/radarad/files/2021-02/Manuscript%20describing%20functional%20domains.pdf
D6.4 Full implementation of communication strategy (M12) RADAR-AD 11-12-2019 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5cb4c786c&appId=PPGMS
D4.7 Post-study-start release of deployable plug-in components RADAR-AD 02-11-2020 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5d67cd016&appId=PPGMS
D3.9 Briefing package for stakeholders RADAR-AD 01-05-2020 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5cf4504c1&appId=PPGMS
D2.6 Confirmed Prioritized list of functional domains for use in WP5 RADAR-AD 22-01-2020 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5d58465f8&appId=PPGMS
D3.8 Report with assessment of regulatory situation RADAR-AD 29-06-2021 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5d67c8ce9&appId=PPGMS Remote Monitoring Technologies,Qualification Opinions Qualification Advices
D3.2 Second meeting standing patient advisory group Lead RADAR-AD 04-01-2021 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5d93ebfce&appId=PPGMS
Title First author last name Year Project Link Keywords  
Sensors in Everyday Objects for Dementia Care Stavropoulos 2019 RADAR-AD https://healthmanagement.org/c/healthmanagement/issuearticle/sensors-in-everyday-objects-for-dementia-care?fbclid=IwAR2MmEbgFtd42E991doeCeMT3w6e9iPvcQEE65v34Q-mcZ28EgAz884iMBc dementia, care, sensors
Selecting Remote Measurement Technologies to Optimize Assessment of Function in Early Alzheimer's Disease: A Case Study Owens 2020 RADAR-AD https://doi.org/10.3389/fpsyt.2020.582207 Alzheimer’s disease, dementia—Alzheimer disease, function, mild cognitive impairment—MCI, remote measurement technologies, telemedicine, activities of daily living
The Role of Heart Rate Variability in the Future of Remote Digital Biomarkers Owens 2020 RADAR-AD https://doi.org/10.3389/fnins.2020.582145 autonomic nervous system, digital biomarkers, heart rate variability, homeostasis, neurovisceral integration, remote measurement technologies
Remote monitoring technologies in Alzheimer's disease: design of the RADAR-AD study Muurling 2021 RADAR-AD https://doi.org/10.1186/s13195-021-00825-4 Alzheimer’s disease; Remote monitoring technologies; Wearable technologies.
Wearable Devices for Assessing Function in Alzheimer's Disease: A European Public Involvement Activity About the Features and Preferences of Patients and Caregivers Stavropoulos 2021 RADAR-AD https://doi.org/10.3389/fnagi.2021.643135 Alzheimer's disease; caregivers; dementia—Alzheimer disease; internet of the things; public involvement; technology acceptance and adoption; technology acceptance and perception; wearable sensors devices.
IoT Wearable Sensors and Devices in Elderly Care: A Literature Review Stavropoulos 2020 RADAR-AD https://doi.org/10.3390/s20102826
The Use of Remote Monitoring Technologies: A Review of Recent Regulatory Scientific Advices, Qualification Opinions, and Qualification Advices Issued by the European Medicines Agency Dekker 2021 RADAR-AD https://doi.org/10.3389/fmed.2021.619513 European Medicine Agency; qualification advices; qualification opinions; remote monitoring devices; scientific advices.
Exploring Network Properties Across Preclinical Stages of Alzheimer’s Disease Using a Visual Short-Term Memory and Attention Task with High-Density Electroencephalography Lazarou 2022 RADAR-AD https://doi.org/10.3233/jad-215421 Alzheimer’s disease; brain networks; electroencephalography; mild cognitive impairment; subjective cognitive decline; visual attention; visual short-term memory.
Title Description Type Project  
Real-world data from RADAR-AD study of multiple wearable and digital devices

RADAR-AD will undertake a prospective multi-center study to test different types of remote monitoring technology (RMT). RADAR-AD will test wearables, portable technologies and fixed sensors. Study numbers: n = 50 preclinical AD, n = 60 prodromal AD, n = 70 mild/moderate AD, n= 40 healthy controls. Data will be captured and modelled using the RADAR-BASE platform (https://radar-base.org/index.php/home/about-us/). For more information, please visit:

https://www.radar-ad.org/our-research/our-scientific-approach

dataset-clinical-radar-ad-13 RADAR-AD
Patient Advisory Board

RADAR-AD has established a Patient Advisory Board (PAB) which is composed of people living with AD and AD support groups. RADAR-AD holds regular consultation sessions with the PAB, covering topics such as the feasibility and acceptability of different interventions, and the wording of participant information documents. For more information, please visit:

https://www.radar-ad.org/patient-engagement/patient-advisory-board/our-work

sem-clinical-radar-ad-3 RADAR-AD
Advanced augmented reality monitor for assessing the risk of Alzheimer and Dementia

The test is based on two augmented reality gamified tasks. In the first task virtual objects appearing on the video image captured by the device active camera will be hidden in some specific part of the room and need to be retrieved some minute afterward. A second test require to navigate through the room by watching in the images of the environment transmitted by the camera of the device while a virtual situation of danger and stress is simulated. The execution of these tests requires an active functional engagement of several cognitive dimension and is captured by the device sensors every second. The duration is typically about 15 minutes.

https://altoida.com/

tools-clinical-radar-ad-12 RADAR-AD
Daily life tasks monitoring app for cognitive status assessment (Banking App)

A smartphone Banking App has been developed by CERTH to assess parameters related to the ability of managing finances during a clinical trial in the context of Dem@Care (http://demcare.eu). The cross-border trial with 190 participants in Thessaloniki, Greece and 100 in Nice, France revealed high accuracy (more than 80%) to discriminate between healthy, MCI and AD cognitive states, while the banking app itself found statistically significant differences between the three groups in multiple parameters e.g. time to complete, fictional correct input (PIN number, account number), number of attempts etc. The app is implemented as a web application with a responsive User Interface which means it may be used on any PC, tablet or smartphone device. It simulates realistic usage of a bank ATM, prompting for PIN code, amount and account number to transfer money to, in attempt to pay the bills. Meanwhile, it measures parameters related to the disease such as number of attempts, correctness of input, duration etc. The Banking App is recommended for usage in a lab setting under guidance of professionals as an assessment (not a monitoring tool), which is its purpose in RADAR-AD.

tools-clinical-radar-ad-13 RADAR-AD
Advanced data management dashboard for monitoring of data continuity from remote sensors

Development of RADAR-AD near real-time dashboard to establish appropriate Grafana alerts for clinical teams based on participant data status. This significantly improved design for dashboarding the data flowing through the RADAR-base has a number of advantages over previous iterations.

tools-non-clinical-radar-ad-28 RADAR-AD
Advanced passive remote monitoring (pRMT) application for user behavior modelling.

Current pRMT app from RADAR-base collects sensor data, such as number/duration of incoming/outgoing calls, caller ID; number/length of incoming/outgoing SMS.

https://radar-base.org/index.php/data-sensors

tools-non-clinical-radar-ar-30 RADAR-AD
Manual data upload tool for remote monitoring sensors data acquisition files.

The RADAR-base platform was developed in the framework of the IMI RADAR-CNS project and provides an end-to-end solution to collect, manage, store and visualize sensor data from smartphones and wearable devices to enable remote monitoring of study participants and decentralized clinical trials. The platform supports multiple devices for passive data collection as well as surveys and questionnaires for active participants feedback. The following data streams can be collected from smartphone sensors: Relative location, Acceleration, Gyration, Magnetic field, Step count, Light, Phone interaction status, Application usage, Bluetooth devices, Battery level. Depending on the connected wearable devices, a wide range of data streams can be collected, e.g. Acceleration, Heart rate, Electrodermal activity, Temperature, Sleep and Physical Activity.

tools-non-clinical-radar-ar-31 RADAR-AD
Mezurio - A smartphone app supporting active participation in research studies and clinical trials

Mezurio is a smartphone app developed through a pre-competitive collaboration between industry (Lilly & Roche) and academia (University of Oxford), based on the very earliest neural and cognitive correlates of preclinical Alzheimer's disease (AD), utilising both active and passive data collection, and which is open and freely available to scientists. Emphasis has been placed on designing interactive experiences, which participants find engaging, thus enabling repeat, remote measurement in a little-but-often format over extensive periods. Participants interact with the app for no more than 10 minutes at a regular time of their own choosing, during each day of the study. They complete a mix of gamified tasks and short self-report questionnaire measures. The tasks cover ecologically valid measure of the kinds of complex cognition required for activities of daily living, including episodic, semantic, and spatial memory over real-world durations, executive components of attention and planning, verbal story telling tasks which test free-recall and fluency. The difficulty of each task adapts to the participants’ own abilities. Finally, the participants will be asked to install and use a keyboard dynamics module.

https://mezur.io

tools-non-clinical-radar-ar-32 RADAR-AD
Priority list of functional domains.

It is critical to define appropriately the targets functional domains for remote monitoring technologies (RMT) used in clinical studies of Alzheimer’s disease (AD) patients. The project published a prioritised list of functional domains that are likely to be specific and sensitive to early stages of AD progression and predictive of deleterious long-term outcomes such as loss of independence and nursing home entry. These findings can be applied to any clinical study that wishes to measure function in early AD or employ RMTs to measure health parameters and disease progression remotely.

https://www.frontiersin.org/articles/10.3389/fpsyt.2020.582207/full#h6

tools-clinical-radar-ad-15 RADAR-AD

 

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