Dementia DisorderDemRegNCT07433010
German Dementia Registry
An observational study of Dementia Disorder, run by RWTH Aachen University at 24 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia Disorder
- What is being tested?
- This is a registry.
- How many people
- 5,000 participants
- Where
- 24 sitesGermany
- Study dates
- 16 May 2022to Dec 2099
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Prof. Dr. Kathrin Reetz, MD contact
24 sites in 1 country
Germany24 sites, 24 recruiting
- Recruiting
RWTH Aachen University Hospital
Aachen, North Rhine-Westphalia, 52074
Prof. Dr. Jörg B. Schulz, +49 0241 80-89600, NE-Wissenschaftsmanagement@ukaachen.de
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
- Recruiting
Charité Campus Benjamin Franklin
Berlin, State of Berlin, 12203
- Recruiting
Klinikum Bremen-Ost
Bremen, Free Hanseatic City of Bremen, 28325
- Not yet recruiting
University Hospital Cologne
Cologne, North Rhine-Westphalia, 50937
- Recruiting
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
- Recruiting
University Hospital Essen
Essen, North Rhine-Westphalia, 45147
- Recruiting
Klinikum Frankfurt (Oder)
Frankfurt (Oder), Brandenburg, 15236
- Recruiting
University Medical Center Göttingen
Göttingen, Lower Saxony, 37075
- Recruiting
Greifswald University Medicine
Greifswald, Mecklenburg-Vorpommern, 17489
- Recruiting
Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20251
- Recruiting
Asklepios Klinik Nord
Hamburg, Free and Hanseatic City of Hamburg, 22419
- Recruiting
Heidelberg University Hospital
Heidelberg, Baden-Wurttemberg, 69120
- Recruiting
Saarland University Medical Center
Homburg, Saarland, 66421
- Not yet recruiting
University Hospital Jena
Jena, Thuringia, 07747
- Recruiting
University Hospital Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105
- Recruiting
Pfalzklinikum Klingenmünster
Klingenmünster, Rhineland-Palatinate, 76889
- Recruiting
University of Leipzig Medical Center
Leipzig, Saxony, 04103
- Recruiting
Madical Faculty University Hospital Magdeburg
Magdeburg, Saxony-Anhalt, 39120
- Not yet recruiting
University Medical Center Mainz
Mainz, Rhineland-Palatinate, 55131
- Recruiting
ZI Mannheim
Mannheim, Baden-Wurttemberg, 68159
- Recruiting
Immanuel Klinik Rüdersdorf
Rüdersdorf, Brandenburg, 15562
- Recruiting
University Hospital Tübingen
Tübingen, Baden-Wurttemberg, 72076
- Recruiting
Ulm University Hospital
Ulm, Baden-Wurttemberg, 89070
About this study
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.
Read the 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).
- Conditions
- Dementia Disorder
- Being tested
- This is a registry.
- Keywords
- Dementia, Registry, Biomarkers, Neurodegeneration, Natural history, Treatment, Mild Cognitive Impairment
- Medical subject headings
- Alzheimer Disease, Dementia, Nerve Degeneration, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a registry.Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start16 May 2022
- Primary completionDec 2099 (estimated)
- Study completionDec 2099 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai GmbH, Lilly Deutschland GmbH Germany, Biogen
- Responsible party
- Principal investigator, Prof. Dr. Jörg B. Schulz, MD, RWTH Aachen University
- Investigators
- Jörg B. Schulz, Prof. Dr., Principal investigator, Department of Neurology, RWTH Aachen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433010
- Sponsor's protocol ID
- 19-050
- Other IDs
- DRKS00027547
- Acronym
- DemReg
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German Dementia Registry
- ClinicalTrials.gov ID
- NCT07433010
- Acronym / sponsor ID
- DemReg / 19-050
- Conditions
- Dementia Disorder
- Keywords
- Dementia, Registry, Biomarkers, Neurodegeneration, Natural history, Treatment, Mild Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Eisai GmbH, Lilly Deutschland GmbH Germany, Biogen
- Study start
- 16 May 2022 (actual)
- Primary completion
- Dec 2099 (estimated)
- Study completion
- Dec 2099 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is a registry.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. | Other | – |
Primary outcome
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.
Time frame: 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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- The German Dementia Registry (DEMREG): study protocol of a biomarker-based national registry for cognitive impairment and dementia \| Neurological Research and Practice \| Springer Nature LinkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. Dr. Kathrin Reetz, MD contact
Jörg B. Schulz, Prof. Dr. principal investigator
Department of Neurology, RWTH Aachen University Hospital
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia Disorder, run by RWTH Aachen University at 24 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Dr. Jörg B. Schulz, MD (+49 241 80-89600, NE-Wissenschaftsmanagement@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.