Inside the 3.000-patient trial design.

The trial recruits across three cohorts: healthy controls aged 45 to 65, people at risk of MCI or early Alzheimer's, and people at risk of early Parkinson's.

Data collection will run for eighteen months, followed by a six-month follow-up. The protocol is planned for pre-registration on ClinicalTrials.gov.

The trial supports the CE technical file, DiGA dossier, UK reimbursement submission, and peer-reviewed publications.