A Methylation Profiling Diagnostic for Early Diagnosis of Alzheimer’s disease

Each year an estimated 40M people suffer from Alzheimer’s disease (AD) globally, and a new case is diagnosed every 4 seconds, leading to a substantial socioeconomic burden of over €800B annually. Despite this large need, currently there is no cure available for AD. Moreover, the clinical trial failure rate for novel AD therapies being tested is over 99%.

Every failed trial leads to large financial losses for the trial sponsor, and as a result there is an urgent need to reimagine AD clinical trial design.

Recently, there has been a paradigm shift in the design of AD clinical trials, with most new trials now focusing on enrollment of Prodromal AD (P-AD) patients.

However, patient recruitment in the P-AD stage is challenging as current methodologies (PET, MRI) lead to a large number of false positive and negative cases. As a result, optimal stratification of P-AD patients during clinical trial recruitment, remains an unmet market need.

To meet this market need, ADmit Therapeutics, an innovative diagnostics SME, aims to deliver MAP-AD: an automated epigenetic analysis platform for accurate prediction of progression status of P-AD patients.

The MAP-AD platform relies on novel machine learning algorithms that can identify specific methylation patterns in mitochondrial DNA (mtDNA) isolated from the blood samples of P-AD patients.

This allows for a rapid and accurate selection of patients to be enrolled into a clinical trial independent of Aβ status, for the first time.

During this EIC Accelerator project, we will finalize the development of our predictive algorithms together with a dedicated software interface, and perform clinical validation in collaboration with our hospital partners to deliver a finalized platform that is ready for commercial launch.

We have a strong network of partners such as Bellvitge University Hospital, Hospital Clinic de Barcelona, CITA-Alzheimer, Hospital Moisès Broggi, Hospital General de l'Hospitalet, Janssen, Roche who will be the early adopters of MAP-AD.