German Dementia Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 24
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
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.
时间窗: 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.
次要结局
未报告次要终点
研究者
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