REALISE
Preparedness of German specialists and memory clinics to deliver early and accurate diagnosis for AD disease‐modifying treatment
General
The early detection of Alzheimer's disease using biomarkers is a prerequisite for the use of new antibody therapies in the treatment of the disease, which are currently undergoing the approval process in the EU. Furthermore, non-pharmacological interventions may exert a beneficial effect on the progression of Alzheimer's disease, particularly when diagnosed at an early stage. In light of this, the DZNE is undertaking a nationwide online survey of memory clinics and neurological and psychiatric practices. The project is scheduled to span a period of one and a half years, with the Lilly Deutschland GmbH assuming responsibility for the associated costs, estimated at approximately 150,000 euros.
Background and aims
The S3 guideline on dementia, published in November 2023, emphasises the importance of early detection in the diagnosis of dementia. Mild cognitive impairment (MCI) is recognised as an early or risk syndrome of dementia. In this context, biomarker-based diagnostics are of central importance.
Furthermore, the European Medicines Agency is currently deciding on the approval of two amyloid antibody therapies. In order to identify suitable patients for these novel therapies, comprehensive dementia diagnostics are required, preferably at the risk stage. Furthermore, antibody therapy necessitates the implementation of a rigorous monitoring system to promptly recognise and treat serious adverse events, such as ARIA-A or ARIA-H.
The objective of our online survey is to ascertain the current practices employed in the diagnosis of dementia, the opportunities and challenges inherent to these practices, and the extent to which the current capacities of diagnostic procedures are utilised or can be expanded. In light of the potential approval of antibody therapies, we are also interested in the attitudes of medical practitioners towards these therapies and the extent to which they possess the necessary medical infrastructure for administering and monitoring antibody therapies.
The study facilitates the identification of obstacles and chances for biomarker-based diagnostic in context with the potential approval of antibody therapies.
Overview
The study, entitled "REALISE: pREparedness of GermAn speciaLIsts and memory clinicS to deliver Early and accurate diagnosis for AD disease-modifying treatment", funded by Lilly Deutschland GmbH, will employ a multi-phase online survey of physicians who diagnose dementia.
The objective of this survey is to ascertain the importance of early dementia diagnosis using biomarkers, the existing and expandable diagnostic capacities and the attitude and access requirements for treatment with amyloid antibody therapies after possible approval. The online survey will initially be distributed electronically to the heads of German memory clinics.
Subsequently, the group of respondents will be expanded to include neurological and psychiatric specialists in private practice
Principle Investigators:
Dr. Ingo Kilimann
Start of the study: Spring 2024
Status: survey in progress