Peripheral Biomarker Based Combinatorial Early Diagnostics for Dementia

Project Information

CombiDiag

Grant agreement ID: 101071485

DOI

10.3030/101071485

EC signature date 28 June 2022

Start date 1 February 2023

End date 31 July 2027

Funded under

• Marie Skłodowska-Curie Actions (MSCA)

Total cost

No data

EU contribution

€ 2 160 201,60

Coordinated by

UNIVERSITATSMEDIZIN ROSTOCK
Germany

Periodic Reporting for period 1 - CombiDiag (Peripheral Biomarker Based Combinatorial Early Diagnostics for Dementia)

Reporting period: 2023-02-01 to 2025-01-31

Summary of the context and overall objectives of the project

CombiDiag DN aims to develop an AI-data-driven peripheral biomarker based combinatorial diagnostic protocol for early stages of Alzheimers disease (AD), a major form of dementia, and to train a new generation of fellows for this interdisciplinary field. Dementia, a devastating disease of older age, is the challenge of our lifetime and one of the Societal Challenges listed by the UN Sustainable Development Goals and Horizon Europe. CombiDiag responds to this challenge to establish a much-needed DN to carry out an integrated study of minimally invasive and cost-effective peripheral biomarkers, including body fluid markers from blood, urine and saliva, and digital markers from speech, motor functions and sleep for developing the combinatorial early AD diagnostics. The consortium comprises nine academic and eight non-academic institutions across Europe, USA, Canada, and China. It synergises leading academic and industrial experts worldwide to build a triple-i research and training platform for the training of a new generation of Fellows to take early AD diagnostic research to a new level. Fellows will be trained under the Vitae Researcher Development Framework innovatively combined with the CombiDiag platform for triple-i scientific and transferable skills as well as personal quality, creative thinking, and business mind-set. The DN has a highly innovative research programme for the discovery of peripheral AD biomarkers, detection techniques, AI/data driven technology, clinical validation, and integration into trial designs. The advances in CombiDiag research will enable a case finding tool at primary care level for helping achieve improved drug discoveries, disease-modifying treatments, preventive strategies and care provision for AD. CombiDiag will deliver 10 highly-skilled, creative and entrepreneurial Fellows, setting them on a path to successful careers in academia or industry to ensure that the medical and societal challenges imposed by AD are met.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

**Scientific Summary:**

The CombiDiag project aims to advance research in early Alzheimer's disease (AD) diagnostics through cutting-edge scientific objectives and innovative methodologies. Significant progress has been made in discovering peripheral biomarkers from blood, saliva, urine, motor, speech, and sleep using laboratory-based techniques. Specifically, 26 metabolites have been identified as potential differentiators between AD patients and healthy controls, leading to the development of the NeuroDeGene® tool for early diagnosis.

The project also focuses on cross-validating these biomarkers through a proof-of-concept clinical study, developing an AI-driven diagnostic protocol for early AD detection, creating a data sharing platform, and conducting clinical validation trials. Additionally, efforts are underway to develop a business model for maximizing societal and economic impact.

The collaborative efforts of the partners involved have resulted in advancements in early AD diagnostics, leveraging data-driven approaches and multidisciplinary collaboration. These efforts aim to improve outcomes for individuals affected by AD by enhancing early detection and management strategies.

**Training Summary:**

CombiDiag's training program integrates a research platform with innovative training methodologies to achieve training objectives for Fellows. The program focuses on providing Fellows with interdisciplinary knowledge and skills spanning engineering, physical science, life science, healthcare, and business to prepare them for future career challenges.

Extensive training has been provided in domain-specific knowledge, hands-on experience, and transferable skills through supervision teams and personal mentoring. Additionally, training events and secondment opportunities with industrial, clinical, and international partners aim to enhance Fellows' triple-i and cultural diversity experience, innovative thinking, and business mindset.

The structured training program implements the Vitae Researcher Development Framework (Vitae RDF) methodology to equip Fellows with essential skills, knowledge, and personal qualities for leadership roles in early AD diagnostics research. The program focuses on developing Fellows into leading experts in their respective fields by providing diverse learning experiences and opportunities for career development.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

na