German Dementia Registry
ConditionDementia Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRWTH Aachen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
This is a registry.
Other interventionThis 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.
Treatment groups
No treatment groups listed
Trial outcomes
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
RWTH Aachen University
Lead sponsor
Eisai GmbH
Collaborator
Lilly Deutschland GmbH Germany
Collaborator
Biogen
Collaborator
Source ClinicalTrials.gov