The German Dementia Registry (DEMREG): study protocol of a biomarker-based national registry for cognitive impairment and dementia.

INTRODUCTION

The German Dementia Registry (DEMREG) is a large-scale national prospective biomarker-based study for cognitive impairment and dementia, providing an integrated clinical research platform for research studies.

METHODS

The DEMREG study longitudinally collects demographic, clinical, genetic, biological, and imaging data, along with risk factors and treatment information from real-world settings. Comprehensive clinical assessments are conducted yearly. This extensive resource enables researchers to investigate current diagnostic and treatment practices and explore the complex relationships between risk factors and outcomes. The registry is now active across 22 sites in Germany, all members of the the German Memory Clinic Network (DNG), with more than 500 patients recruited to date, and is expected to include up to 1.000 patients annually.

PERSPECTIVE: The DEMREG study represents a large nationally harmonized cohort of detailed real-world clinical and biological data from patients with cognitive impairment and dementia, enabling insights into long-term dynamics and treatment responses. This infrastructure has the potential to foster collaborative research and roll out healthcare innovations across different settings in Germany. In this context, a substudy will soon be conducted to evaluate long-term safety and efficacy measures of the new monoclonal antibodies targeting amyloid plaques in a clinical setting.

TRIAL REGISTRATION: The protocol is registered at German Clinical Trials Register (DRKS00027547), Date of Registration: 01.04.2022.