The International Registry for Alzheimer's Disease and Other Dementias (InRAD): An International Registry Observational Study Dedicated to Evaluating Outcomes Data in Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50,000
- 试验地点
- 18
- 主要终点
- Changes in Alzheimer's Disease Clinical Staging over time
研究概览
简要总结
The goal of this international observational study is to evaluate long-term disease outcomes and treatment safety in people with Alzheimer's disease (PwAD), by collecting real-world data from routine clinical practice across global clinical centers.
The InRAD Registry Observational Study has several aims:
- To collect medical information for many years from a large group of people with Alzheimer's disease. This will be used for research, which will support improved understanding about the disease.
- To enable researchers to look at the effectiveness, usefulness and safety of treatments for Alzheimer's disease.
- To enable researchers to answer similar research questions and compare results in many different areas of the world.
People with Alzheimer's disease who meet the eligibility criteria and agree to participate in the Study will be asked to visit their doctor (e.g. psychiatrist, geriatrician, or neurologist) at least once a year, or as frequently as is needed for their care. During or after their appointments they may be offered assessments, tests, medications, and treatments as determined by their doctor and their team. This is an observational data collection.
详细描述
The study protocol is owned by all InRAD Observational Study Investigators. All centers taking part in InRAD are the data controllers. InRAD is a data processor and is providing operational management and system support.
Study Type: Prospective, non-interventional, multinational observational cohort study.
Study Objective: The primary goal of the InRAD Observational Study is to collect and analyze real-world data (RWD) to evaluate long-term disease outcomes and treatment safety in people with Alzheimer's disease (PwAD). The study aims to:
- Assess disease stage transitions, cognitive and functional changes over time.
- Examine the relationship between demographics, comorbidities, diagnostic and monitoring tests, drug exposures, and outcomes.
- Compare disease demographics and outcomes across countries and regions.
- Characterize the occurrence of medical events, including Serious Adverse Events (SAEs) and Adverse Events (AEs), particularly in relation to AD-specific treatments.
Study Population: Adults undergoing diagnostic work-up for Alzheimer's disease or already diagnosed. Includes treated, treatment-eligible, and untreated patients. Participants must be attending an InRAD Center and provide informed consent for long-term follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be undergoing diagnostic work-up for Alzheimer's disease (AD), OR
- •Have a confirmed diagnosis of AD (whether currently treated with an AD-specific treatment, or untreated),
- •Be attending an InRAD Center,
- •Have provided informed consent for long-term follow-up
排除标准
- •Any patient or legal representative who is unable or unwilling to provide a signed informed consent form
研究组 & 干预措施
Alzheimer's Disease Registry Participants
Individuals diagnosed with Alzheimer's disease or undergoing diagnostic work-up, enrolled in the InRAD Registry for long-term observational follow-up. This cohort includes treated, treatment-eligible, and untreated patients across global clinical centers participating in routine care and data collection.
干预措施: None, this is a non-interventional observational study (Other)
结局指标
主要结局
Changes in Alzheimer's Disease Clinical Staging over time
时间窗: 10 years
Use of the "Clinical staging for individuals on the Alzheimer's disease continuum" NIA-AA 2018/24 criteria, ranging from Stage 0 to Stage 6: * Stage 0 Asymptomatic, deterministic gene; * Stage 1 Asymptomatic, biomarker evidence only; * Stage 2 Transitional decline: mild detectable change, but minimal impact on daily function; * Stage 3 Cognitive impairment with early functional impact; * Stage 4 Dementia with mild functional impairment; * Stage 5 Dementia with moderate functional impairment; * Stage 6 Dementia with severe functional impairment.
次要结局
未报告次要终点