ClinicalTrials.gg
RecruitingNCT07433010DemRegUpdated Feb 25, 2026

German Dementia Registry

An observational study in Dementia Disorder, sponsored by RWTH Aachen University. Recruiting at 24 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-25.

Sponsored by RWTH Aachen University · Observational

From the registry’s dates

  • Started May 2022; still recruiting 4 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years and older
Sex
All
01

Study 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 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).

02

Conditions studied

  • Dementia Disorder

Keywords

  • Dementia
  • Registry
  • Biomarkers
  • Neurodegeneration
  • Natural history
  • Treatment
  • Mild Cognitive Impairment
03

In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 200 across 814 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

RWTH Aachen University is the lead sponsor of 230 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Target follow-up
20 Years
Patient registry
Yes

Interventions

  • OtherThis 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.

06

What researchers measure

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.

    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.

07

Study locations

21 of 24 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2022 (actual). Primary completion is estimated for Dec 2099, 931 months after the start.

Of 364 non-industry observational studies under Alzheimer Disease, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 203. This study's planned 931 months is above that.

Counting every sponsor, half of 405 studies reached it within 67 months; a quarter within 35 and three quarters within 171.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2026
First posted
Feb 25, 2026
StartActual
May 16, 2022
Primary completionEst.
Dec 2099
CompletionEst.
Dec 2099
Last update
Feb 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07433010
Collaborators
Eisai GmbH, Lilly Deutschland GmbH Germany, Biogen
Responsible party
Prof. Dr. Jörg B. Schulz, MD (Prof. Dr. Jörg B. Schulz, MD, Head of the Department of Neurology at the University Hospital Aachen and Project Manager, RWTH Aachen University) — Principal investigator
First posted
Feb 25, 2026
Start date
May 16, 2022
Primary completion
Dec 2099 (estimated)
Completion
Dec 2099 (estimated)
Last update
Feb 25, 2026

Study contacts

Prof. Dr. Jörg B. Schulz, MD
Contact
NE-Wissenschaftsmanagement@ukaachen.de
+49 241 80-89600
Prof. Dr. Kathrin Reetz, MD
Contact
Jörg B. Schulz, Prof. Dr.
principal investigator · Department of Neurology, RWTH Aachen University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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