Official start of the RADAR-AD clinical study

The first participant to take part in the RADAR-AD study was included on the 10th of July in our clinical site in Thessaloniki, Greece. This marks the official start of the RADAR-AD clinical study, despite a short delay due to the COVID-19 pandemic. In the upcoming weeks the RADAR-AD consortium expects more inclusions to follow in other clinical sites of the project.

RADAR-AD’s clinical team in Greece preparing for the first clinical visitThe RADAR-AD project aims to assess symptoms of Alzheimer’s disease with remote monitoring technologies, from the early stages of the disease to the dementia stage. Remote monitoring technologies provide the opportunity to measure symptoms continuously (instead of periodic assessment in the clinic) and objectively (without interference of the patient, care giver or physician). In this way, we could possibly assess symptoms more accurately and earlier in the disease process. Moreover, in light of the current pandemic, remote measurement has the benefit that no physical contact is required.

The first participant to be included in the RADAR-AD study was examined on the 10th of July at the Greek Association of Alzheimer's Disease and Related Disorders (GAADRD) in Thessaloniki. Although the participant was recruited from the Medical School of Aristotle University, the RADAR-AD Greek team scheduled the appointment at the GAADRD's facilities for participants' and researchers' convenience. This first visit marks the start of the remote monitoring trial of the RADAR-AD project. It is very important to see whether RADAR-AD can effectively collect data from participants remotely and be able to assess their functional and cognitive status. 

RADAR-AD’s project co-lead Dag Aarsland from King’s College London shares:

'The RADAR-AD Consortium is delighted to announce that July saw the first participant enrolled into RADAR-AD study. Despite the COVID-19 pandemic resulting in RADAR-AD centres across Europe having to suspend recruitment, our colleagues in Thessaloniki, Greece, are the first to able to begin recruitment. After some understandable delays, most other RADAR-AD centres are ready to follow at short notice, as soon as each clinical site is cleared to re-start clinical studies from the relevant regional governing bodies.’

RADAR-AD clinical studies

Ultimately, the RADAR-AD project aims to transform patient care through remote assessment. To achieve this goal, the consortium has set up three clinical studies. The first study is the main one and includes the setting up of wearable devices, such as smartphone apps or activity trackers, when participants make a clinic visit. The main study will be executed across various clinical sites in Europe for approximately 8 weeks. Thereafter, the second study will comprise the installation of digital technologies in participants’ homes and will last for 4 weeks. Lastly, the third study will entail the assessment of use of these digital devices in an existing smart-home environment. The first participant included on the 10th of July will participate in the first study of RADAR-AD.

First participant inclusion in Greece

The Greek team responsible for inclusions of participants for RADAR-AD is represented by Mara Gkioka – neuropsychologist responsible for assessing the participants with regards to their cognitive status for the main RADAR-AD study, Ioulietta Lazarou - psychologist and clinical research associate at CERTH ITI who will be responsible for examining the use of digital devices in an existing smart-home environment, Dr. Thanos Stavropoulos - Post doc research fellow at CERTH ITI, also responsible for examining the use of devices in an existing smart-home environment and Dimitrios Stantzalis - developer at CERTH ITI who was present during the baseline assessment for assisting in technological and platform-related matters.

The RADAR-AD clinical team in Greece followed the clinical protocol developed by the VUmc for the main RADAR-AD study. Therefore, the first participant included in the RADAR-AD study followed baseline assessment including questionnaires, installation of apps and wearable devices, among others. In line with the current regulations surrounding the COVID-19 pandemic, all researchers and the participant wore protective masks, washed their hands and used antiseptics on a regular basis. Moreover, the team maintained distance and kept the windows open all the time during the visit so as to ensure the safety of all people involved.

Future steps

In terms of future steps, the recruitment aims of the RADAR-AD consortium are to follow the clinical protocols and recruit 20 participants in total for its Greek clinical site, and 220 participant in total for all sites. The consortium believes that now it is of utmost importance to be able to monitor the participants remotely. Therefore, the RADAR-AD team will continue to inform the participants about the study and hopes to reach the initial goal set out for the project.

With regard to the rest of RADAR-AD’s clinical sites - the sites in the Netherlands, Germany, Norway, Romania, Slovenia and United Kingdom have already obtained approval from their ethical committees to start the study. They are now preparing the first participant inclusion. On-site training for all clinical sites by the clinical team at the VUmc to align their study procedures was disrupted due to the COVID-19 situation. Instead, the RADAR-AD consortium has developed training videos which can be used to replace the initially planned physical trainings. In this way researchers can familiarize themselves with the devices and study procedures. The consortium expects that these sites will start with the inclusion of their first participants after the summer holidays.