NCT07433010

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
894mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

24 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
May 2022Dec 2099

Study Start

First participant enrolled

May 16, 2022

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
73.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2099

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2099

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

77.6 years

First QC Date

February 4, 2026

Last Update Submit

February 18, 2026

Conditions

Keywords

DementiaRegistryBiomarkersNeurodegenerationNatural historyTreatmentMild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

This is an observational study; no treatments are carried out within the scope of the registry. The usual treatment/medication of patients is merely documented. Additionally, using a variety of questionnaires and tests, data is generated from participants in relation to early dementia.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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.
  • Unable or unwilling to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Heidelberg University Hospital

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

ZI Mannheim

Mannheim, Baden-Wurttemberg, 68159, Germany

RECRUITING

University Hospital Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Ulm University Hospital

Ulm, Baden-Wurttemberg, 89070, Germany

RECRUITING

Universitätsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

RECRUITING

Klinikum Frankfurt (Oder)

Frankfurt (Oder), Brandenburg, 15236, Germany

RECRUITING

Immanuel Klinik Rüdersdorf

Rüdersdorf, Brandenburg, 15562, Germany

RECRUITING

Klinikum Bremen-Ost

Bremen, City state Bremen, 28325, Germany

RECRUITING

Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, 20251, Germany

RECRUITING

Asklepios Klinik Nord

Hamburg, Hamburg, 22419, Germany

RECRUITING

University Medical Center Göttingen

Göttingen, Lower Saxony, 37075, Germany

RECRUITING

Greifswald University Medicine

Greifswald, Mecklenburg-Vorpommern, 17489, Germany

RECRUITING

RWTH Aachen University Hospital

Aachen, North Rhine-Westphalia, 52074, Germany

RECRUITING

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

NOT YET RECRUITING

University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

RECRUITING

Pfalzklinikum Klingenmünster

Klingenmünster, Rhineland-Palatinate, 76889, Germany

RECRUITING

University Medical Center Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

NOT YET RECRUITING

Saarland University Medical Center

Homburg, Saarland, 66421, Germany

RECRUITING

University of Leipzig Medical Center

Leipzig, Saxony, 04103, Germany

RECRUITING

Madical Faculty University Hospital Magdeburg

Magdeburg, Saxony-Anhalt, 39120, Germany

RECRUITING

University Hospital Schleswig-Holstein

Kiel, Schleswig-Holstein, 24105, Germany

RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

RECRUITING

Charité Campus Benjamin Franklin

Berlin, State of Berlin, 12203, Germany

RECRUITING

University Hospital Jena

Jena, Thuringia, 07747, Germany

NOT YET RECRUITING

Related Links

MeSH Terms

Conditions

Alzheimer DiseaseDementiaNerve DegenerationCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsCognition Disorders

Study Officials

  • Jörg B. Schulz, Prof. Dr.

    Department of Neurology, RWTH Aachen University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Dr. Jörg B. Schulz, MD

CONTACT

Prof. Dr. Kathrin Reetz, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Jörg B. Schulz, MD, Head of the Department of Neurology at the University Hospital Aachen and Project Manager

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 25, 2026

Study Start

May 16, 2022

Primary Completion (Estimated)

December 1, 2099

Study Completion (Estimated)

December 1, 2099

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Locations