German registry for dementia and early memory problems

German Dementia Registry

This registry will collect clinical and biomarker information over time from people in Germany with subjective cognitive decline, mild cognitive impairment, or early dementia to see how symptoms and tests change.

Quick facts

• Study type: Observational
• Enrollment: 5000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: RWTH Aachen University (Academic / other)
• Locations: 24 sites (Heidelberg, Baden-Wurttemberg and 23 other locations)
• Trial ID: NCT07433010 on ClinicalTrials.gov

What this trial studies

The German Dementia Registry is a prospective, multicenter platform that collects longitudinal real-world clinical data and biomarker results from patients with SCD, MCI, and early dementia across participating German sites. Data are entered via an online platform and aligned with diagnostic and treatment guidelines to capture routine clinical practice. The registry will track disease progression, biomarker dynamics (for example CSF amyloid and tau measures), and treatment patterns to help distinguish Alzheimer's disease from other dementia causes. Collected information is intended to support improved early diagnostic criteria and inform use of newly approved treatments in real-world settings.

Who should consider this trial

Good fit: Adults in Germany who can provide informed consent (or have a legal representative), have a diagnosis of subjective cognitive decline, mild cognitive impairment, or early dementia, and have or are willing to undergo biomarker testing are ideal candidates.

Not a fit: People with advanced or late-stage dementia, those without available biomarker data, or those who cannot consent or attend participating German centers are unlikely to receive direct benefit from this registry.

Why it matters

Potential benefit: If successful, the registry could improve understanding of dementia progression and help refine biomarker-based early diagnosis and treatment decisions.

How similar studies have performed: Other large cohorts and registries (for example ADNI and several European national registries) have successfully provided natural-history and biomarker data, so this approach builds on established methods rather than being entirely novel.

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.

Where this trial is running

Heidelberg, Baden-Wurttemberg and 23 other locations

• Heidelberg University Hospital — Heidelberg, Baden-Wurttemberg, Germany (Recruiting)
• ZI Mannheim — Mannheim, Baden-Wurttemberg, Germany (Recruiting)
• University Hospital Tübingen — Tübingen, Baden-Wurttemberg, Germany (Recruiting)
• Ulm University Hospital — Ulm, Baden-Wurttemberg, Germany (Recruiting)
• Universitätsklinikum Erlangen — Erlangen, Bavaria, Germany (Recruiting)
• Klinikum Frankfurt (Oder) — Frankfurt (Oder), Brandenburg, Germany (Recruiting)
• Immanuel Klinik Rüdersdorf — Rüdersdorf, Brandenburg, Germany (Recruiting)
• Medical Center Hamburg-Eppendorf — Hamburg, Free and Hanseatic City of Hamburg, Germany (Recruiting)
• Asklepios Klinik Nord — Hamburg, Free and Hanseatic City of Hamburg, Germany (Recruiting)
• Klinikum Bremen-Ost — Bremen, Free Hanseatic City of Bremen, Germany (Recruiting)
• University Medical Center Göttingen — Göttingen, Lower Saxony, Germany (Recruiting)
• Greifswald University Medicine — Greifswald, Mecklenburg-Vorpommern, Germany (Recruiting)
• RWTH Aachen University Hospital — Aachen, North Rhine-Westphalia, Germany (Recruiting)
• University Hospital Cologne — Cologne, North Rhine-Westphalia, Germany (Not_yet_recruiting)
• University Hospital Essen — Essen, North Rhine-Westphalia, Germany (Recruiting)
• Pfalzklinikum Klingenmünster — Klingenmünster, Rhineland-Palatinate, Germany (Recruiting)
• University Medical Center Mainz — Mainz, Rhineland-Palatinate, Germany (Not_yet_recruiting)
• Saarland University Medical Center — Homburg, Saarland, Germany (Recruiting)
• University of Leipzig Medical Center — Leipzig, Saxony, Germany (Recruiting)
• Madical Faculty University Hospital Magdeburg — Magdeburg, Saxony-Anhalt, Germany (Recruiting)
• University Hospital Schleswig-Holstein — Kiel, Schleswig-Holstein, Germany (Recruiting)
• Charité - Universitätsmedizin Berlin — Berlin, State of Berlin, Germany (Recruiting)
• Charité Campus Benjamin Franklin — Berlin, State of Berlin, Germany (Recruiting)
• University Hospital Jena — Jena, Thuringia, Germany (Not_yet_recruiting)

Study contacts

• Principal investigator: Jörg B. Schulz, Prof. Dr. — Department of Neurology, RWTH Aachen University Hospital
• Study coordinator: Prof. Dr. Jörg B. Schulz, MD

Conditions Dementia Disorder; Dementia; Registry; Biomarkers; Neurodegeneration; Natural history; Treatment; Mild Cognitive Impairment