German Dementia Registry

Обзор

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.

Подробное описание

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).

Вмешательства

• Другое 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.

Первичные конечные точки

• 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. [Срок оценки: 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.]

Критерии участия

Критерии включения

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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 24 центра

• Heidelberg University Hospital — Heidelberg
• ZI Mannheim — Mannheim
• University Hospital Tübingen — Tübingen
• Ulm University Hospital — Ulm
• Universitätsklinikum Erlangen — Erlangen
• Klinikum Frankfurt (Oder) — Frankfurt (Oder)
• Immanuel Klinik Rüdersdorf — Rüdersdorf
• Medical Center Hamburg-Eppendorf — Hamburg
• … и ещё 16 центров

Идентификаторы

NCT: NCT07433010 · 19-050 · DRKS00027547

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗