RecruitingRecruiting
German Dementia Registry
NCT07433010 · RWTH Aachen University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
The aim of the German Dementia Registry is to prospectively collect longitudinal real-world data on all consenting patients diagnosed in clinical routine with Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI), and early dementia of different etiologies in Germany, independent of their actual treatment regimen. For this purpose, an online platform will be provided.
Data are collected during patient visits and items for data collection are aligned with diagnostic/treatment guidelines and clinical procedures. The disease specific registry will be conducted to prospectively follow the natural course of dementia and to differentiate e.g. patients with Alzheimer's dementia from patients with dementia of other etiology.
The data collected will provide prospective and longitudinal data demonstrating the natural course of disease and the current diagnostic and treatment behavior in clinical routine in the German healthcare system. Prospective monitoring of dementia patients is expected to lead to a better understanding of the natural history of dementia and the changes in biomarker values within different etiologies of dementia. This can help to improve and adapt the early diagnostic criteria regarding biomarkers and real-world data for patients on newly approved treatments (e.g. amyloid antibodies).
Eligibility criteria
Inclusion Criteria:
Inclusion Criteria for Patient:
* Ability of the participant and/or his/her legally authorized representative (e.g., spouse or legal guardian), as appropriate and applicable, to understand the purpose and risks of the register and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local privacy regulations.
* Participating patients must have a diagnosis of SCD, MCI or early dementia of different etiology (i.e. Alzheimer's Disease, Frontotemporal Dementia, Parkinson's Disease, Lewy-Body Dementia, Progressive Supranuclear Palsy, Corticobasal Degeneration, Normal Pressure Hydrocephalus, Major Depression; Vascular Dementia; TDP-43 associated limbic encephalopathy (LATE), Mixed Dementia AD + VaD, Prion-Associated Dementia) together with biomarkers such as cerebrospinal fluids (CSF) amyloid beta 1-42, amyloid beta 1-40, amyloid beta 1-42/amyloid beta 1-40 ratio, total tau and phosphorylated tau, amyloid or tau imaging.
* At least 18 years of age.
Inclusion Criteria for family member:
* At least 18 years of age.
* Patient was included in the registry
* Family member is strongly involved to the patient's life according to the patient's statement
* Ability of the participant, as appropriate and applicable, to understand the purpose and risks of the register
Exclusion Criteria:
Exclusion Criteria for Patient:
* Unwilling to provide informed consent.
* No available biomarkers such as cerebrospinal fluids (CSF) amyloid beta 1-42, amyloid beta 1-40, amyloid beta 1-42/amyloid beta 1-40 ratio, total tau and phosphorylated tau, amyloid or tau imaging.
Exclusion Criteria for family member:
* Unable or unwilling to provide informed consent.
Study design
Enrollment target: 5000 participants
Age groups: adult, older_adult
Timeline
Starts: 2022-05-16
Estimated completion: 2099-12
Last updated: 2026-02-25
Interventions
Other: This is a registry.
Primary outcomes
- • The primary objective is the development of a registry to collect longitudinal data on patients with cognitive impairment and dementia with fluid biomarkers in Germany. (This is an open-ended prospective registry. Data is collected during a baseline visit. Follow-up visits are conducted on an annual basis (1 year ±3 months) for as long as possible for each patient.)
Sponsor
RWTH Aachen University · other
With: Eisai GmbH, Lilly Deutschland GmbH Germany, Biogen
Contacts & investigators
ContactProf. Dr. Jörg B. Schulz, MD · contact · NE-Wissenschaftsmanagement@ukaachen.de · +49 241 80-89600
ContactProf. Dr. Kathrin Reetz, MD · contact
InvestigatorJörg B. Schulz, Prof. Dr. · principal_investigator, Department of Neurology, RWTH Aachen University Hospital
All locations (24)
Heidelberg University HospitalRecruiting
Heidelberg, Baden-Wurttemberg, Germany
ZI MannheimRecruiting
Mannheim, Baden-Wurttemberg, Germany
University Hospital TübingenRecruiting
Tübingen, Baden-Wurttemberg, Germany
Ulm University HospitalRecruiting
Ulm, Baden-Wurttemberg, Germany
Universitätsklinikum ErlangenRecruiting
Erlangen, Bavaria, Germany
Klinikum Frankfurt (Oder)Recruiting
Frankfurt (Oder), Brandenburg, Germany
Immanuel Klinik RüdersdorfRecruiting
Rüdersdorf, Brandenburg, Germany
Medical Center Hamburg-EppendorfRecruiting
Hamburg, Free and Hanseatic City of Hamburg, Germany
Asklepios Klinik NordRecruiting
Hamburg, Free and Hanseatic City of Hamburg, Germany
Klinikum Bremen-OstRecruiting
Bremen, Free Hanseatic City of Bremen, Germany
University Medical Center GöttingenRecruiting
Göttingen, Lower Saxony, Germany
Greifswald University MedicineRecruiting
Greifswald, Mecklenburg-Vorpommern, Germany
RWTH Aachen University HospitalRecruiting
Aachen, North Rhine-Westphalia, Germany
University Hospital CologneNot Yet Recruiting
Cologne, North Rhine-Westphalia, Germany
University Hospital EssenRecruiting
Essen, North Rhine-Westphalia, Germany
Pfalzklinikum KlingenmünsterRecruiting
Klingenmünster, Rhineland-Palatinate, Germany
University Medical Center MainzNot Yet Recruiting
Mainz, Rhineland-Palatinate, Germany
Saarland University Medical CenterRecruiting
Homburg, Saarland, Germany
University of Leipzig Medical CenterRecruiting
Leipzig, Saxony, Germany
Madical Faculty University Hospital MagdeburgRecruiting
Magdeburg, Saxony-Anhalt, Germany
University Hospital Schleswig-HolsteinRecruiting
Kiel, Schleswig-Holstein, Germany
Charité - Universitätsmedizin BerlinRecruiting
Berlin, State of Berlin, Germany
Charité Campus Benjamin FranklinRecruiting
Berlin, State of Berlin, Germany
University Hospital JenaNot Yet Recruiting
Jena, Thuringia, Germany