Alzheimer's National Registry for Treatment and Diagnostics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Evaluate whether FDA-approved treatments improve health outcomes (as measured by slowing of functional decline) over time in a real-world population in broad clinical settings.
研究概览
简要总结
The Alzheimer's Network for Treatment and Diagnostics (ALZ-NET) will collect longitudinal clinical and safety data for enrolled patients being evaluated for or treated with novel FDA-approved Alzheimer's disease (AD) therapies. ALZ-NET is a longitudinal registry with an expandable platform, designed to grow with scientific and medical advancements. As new treatments are approved and implemented in care, ALZ-NET will track the long-term health outcomes associated with their use in a real-world setting. ALZ-NET is a resource for evidence gathering, information sharing and education across clinical and research communities, encouraging innovative research and supporting opportunities to improve clinical care delivery. All participating physicians and site staff will complete comprehensive training to ensure adherence of data requirements and registry timelines.
详细描述
ALZ-NET is collecting longitudinal clinical and safety data for enrolled patients that are being evaluated for or being treated with novel FDA-approved AD therapies. ALZ-NET is a longitudinal registry with an expandable platform, designed to grow with scientific and medical advancements. As new treatments are approved and implemented in care, ALZ-NET will track the long-term health outcomes associated with their use in a real-world setting. ALZ-NET aims to assess the clinical course of people from a variety of backgrounds and communities, to achieve representativeness beyond the populations historically enrolled in clinical trials. ALZ-NET will be a resource for evidence gathering, information sharing, and education across clinical and research communities, encouraging innovative, inclusive research and supporting opportunities to improve clinical care delivery.
ALZ-NET will align with the following objectives:
- Collect baseline and longitudinal patient data, including measures of cognition, function, and long-term safety.
- Collect and archive diagnostic, neuroimaging, genetic and fluid biomarkers.
- Track health outcomes and resource utilization through existing databases.
- Share deidentified data, images and biosamples with the research community and other stakeholders.
All participating physicians and site staff will complete comprehensive training to ensure adherence of data requirements and registry timelines. ALZ-NET will collect longitudinal data through site submitted case report forms and payer claims. Additional objectives of ALZ-NET are to establish a biorepository of plasma, CSF and DNA samples and to archive brain images from participants who consent to these optional elements.
In addition to the aims and objectives outlined within this protocol, ALZ-NET will serve as a backbone registry and platform for collection of regulatory grade data and collaboration with affiliated studies. Affiliated studies are thoroughly reviewed by the ALZ-NET Steering Committee before receiving affiliation approval. ALZ-NET will allow for seamless co enrollment of participants that are being evaluated for or receiving a novel FDA-approved treatment for AD. This collaboration structure is designed to reduce the operational burden of participating sites and patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •Patient or patient's legally authorized representative (LAR) or proxy (e.g., spouse or legal guardian) has the ability to understand the purpose and risks of ALZ-NET and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local patient privacy regulations.
- •Patient is at least 18 years of age at the time of informed consent.
- •Patient has a diagnosis of MCI or dementia with clinical suspicion of AD as contributing pathology and (1) is being evaluated for treatment or, (2) will be initiating treatment, or (3) has already initiated treatment with novel FDA-approved AD therapies in real-world clinical practice.
- •If treatment is initiated at the time of consent, patient meets appropriate label requirements and treatment follows appropriate use recommendations for novel FDA-approved AD therapy/therapies.
- •Patient's treating clinician has made the decision to provide clinical care or treatment prior to patient consent and independently of the purpose of ALZ-NET.
排除标准
- 未提供
结局指标
主要结局
Evaluate whether FDA-approved treatments improve health outcomes (as measured by slowing of functional decline) over time in a real-world population in broad clinical settings.
时间窗: 2 years
The primary measure of functional status will be the overall score of the Functional Activities Questionnaire (FAQ). FAQ is measured on a scale of 0 to 30 with higher scores indicating more impaired function.
Evaluate whether FDA-approved treatments improve health outcomes (as measured by slowing of cognitive decline) over time in a real-world population in broad clinical settings.
时间窗: 2 years
The primary measures of cognitive status will be the overall score of the Mini Mental State Examination (MMSE). MMSE is measured on a scale of 0 to 30 with higher scores indicating better cognitive function.
Evaluate safety outcomes of FDA-approved treatments over time in a real-world population in broad clinical settings.
时间窗: 2 years
The measures of safety will be summaries of rates of adverse events over time. Specific safety outcomes of interest include amyloid related imaging abnormalities (ARIA)
次要结局
未报告次要终点