German Dementia Registry (DemReg)

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.

Study Overview

• Status: Recruiting
• Conditions: Dementia Disorder
• Intervention / Treatment: Other: This is a registry.

Detailed Description

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).

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Prof. Dr. Jörg B. Schulz, MD; Phone Number: +49 241 80-89600; Email: NE-Wissenschaftsmanagement@ukaachen.de
• Study Contact Backup: Name: Prof. Dr. Kathrin Reetz, MD

Study Locations

• Germany
  • Baden-Wurttemberg
    • Heidelberg, Baden-Wurttemberg, Germany, 69120
      • Recruiting
      • Heidelberg University Hospital
    • Mannheim, Baden-Wurttemberg, Germany, 68159
      • Recruiting
      • ZI Mannheim
    • Tübingen, Baden-Wurttemberg, Germany, 72076
      • Recruiting
      • University Hospital Tübingen
    • Ulm, Baden-Wurttemberg, Germany, 89070
      • Recruiting
      • Ulm University Hospital
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • Universitätsklinikum Erlangen
  • Brandenburg
    • Frankfurt (Oder), Brandenburg, Germany, 15236
      • Recruiting
      • Klinikum Frankfurt (Oder)
    • Rüdersdorf, Brandenburg, Germany, 15562
      • Recruiting
      • Immanuel Klinik Rüdersdorf
  • City state Bremen
    • Bremen, City state Bremen, Germany, 28325
      • Recruiting
      • Klinikum Bremen-Ost
  • Hamburg
    • Hamburg, Hamburg, Germany, 20251
      • Recruiting
      • Medical Center Hamburg-Eppendorf
    • Hamburg, Hamburg, Germany, 22419
      • Recruiting
      • Asklepios Klinik Nord
  • Lower Saxony
    • Göttingen, Lower Saxony, Germany, 37075
      • Recruiting
      • University Medical Center Göttingen
  • Mecklenburg-Vorpommern
    • Greifswald, Mecklenburg-Vorpommern, Germany, 17489
      • Recruiting
      • Greifswald University Medicine
  • North Rhine-Westphalia
    • Aachen, North Rhine-Westphalia, Germany, 52074
      • Recruiting
      • RWTH Aachen University Hospital
      • Contact: Prof. Dr. Jörg B. Schulz; Phone Number: +49 0241 80-89600; Email: NE-Wissenschaftsmanagement@ukaachen.de
    • Cologne, North Rhine-Westphalia, Germany, 50937
      • Not yet recruiting
      • University Hospital Cologne
    • Essen, North Rhine-Westphalia, Germany, 45147
      • Recruiting
      • University Hospital Essen
  • Rhineland-Palatinate
    • Klingenmünster, Rhineland-Palatinate, Germany, 76889
      • Recruiting
      • Pfalzklinikum Klingenmünster
    • Mainz, Rhineland-Palatinate, Germany, 55131
      • Not yet recruiting
      • University Medical Center Mainz
  • Saarland
    • Homburg, Saarland, Germany, 66421
      • Recruiting
      • Saarland University Medical Center
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • Recruiting
      • University of Leipzig Medical Center
  • Saxony-Anhalt
    • Magdeburg, Saxony-Anhalt, Germany, 39120
      • Recruiting
      • Madical Faculty University Hospital Magdeburg
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Recruiting
      • University Hospital Schleswig-Holstein
  • State of Berlin
    • Berlin, State of Berlin, Germany, 10117
      • Recruiting
      • Charité - Universitätsmedizin Berlin
    • Berlin, State of Berlin, Germany, 12203
      • Recruiting
      • Charite Campus Benjamin Franklin
  • Thuringia
    • Jena, Thuringia, Germany, 07747
      • Not yet recruiting
      • University Hospital Jena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This registry will be conducted in adult patients with a diagnosis of SCD, MCI or early dementia of different etiology and existing 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 will allow to evaluate the current diagnostic and treatment behavior and assess the natural history of a cohort of patients with SCD, MCI or early dementia with fluid and/or imaging biomarkers. The data collected on biomarkers and risk factors will help to differentiate e.g. patients with Alzheimer's dementia from patients with dementia of other etiology and to optimize diagnosis, management and care in a real-life environment.	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.

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Collaborators: Biogen; Eisai GmbH; Lilly Deutschland GmbH Germany
• Investigators: Principal Investigator: Jörg B. Schulz, Prof. Dr., Department of Neurology, RWTH Aachen University Hospital

Publications and helpful links

Helpful Links

• The German Dementia Registry (DEMREG): study protocol of a biomarker-based national registry for cognitive impairment and dementia | Neurological Research and Practice | Springer Nature Link

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2022
• Primary Completion (Estimated): December 1, 2099
• Study Completion (Estimated): December 1, 2099

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Treatment; Mild Cognitive Impairment; Dementia; Neurodegeneration; Biomarkers; Registry; Natural history
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Pathologic Processes; Neurocognitive Disorders; Cognition Disorders; Tauopathies; Neurodegenerative Diseases; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Alzheimer Disease; Dementia; Nerve Degeneration
• Other Study ID Numbers: 19-050; DRKS00027547 (Registry Identifier: DRKS - Deutsches Register Klinischer Studien)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Requests for data are deliberated in the Advisory Committee. If the outcome of the deliberation is positive, the data is passed on to the researchers in pseudonymised form. If the request comes from a commercial partner and the outcome of the deliberation is positive, the data is made available in anonymised form.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No