PPD™ CorEvitas™ International Alzheimer's (ALZ) Drug Safety and Effectiveness Registry
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Alzheimer Disease Epidemiology and presentation
研究概览
简要总结
The design is an open-ended, prospective, observational, (non-interventional) registry for subjects with mild cognitive impairment (MCI), early symptomatic Alzheimer's disease, Alzheimer's disease, or dementia with clinical suspicion of Alzheimer's disease under the care of a neurologist, psychiatrist, geriatrician or other qualified provider. Longitudinal data are collected from subjects, their care partner(s), and their treating healthcare provider during routine clinical encounters using a structured and standardized data collection method. Approximately 2,000 subjects, with no defined upper limit, across around 75 clinical sites worldwide will be recruited.
详细描述
The objective of the registry is to create a prospective cohort of Alzheimer's disease subjects to evaluate long-term real-world safety and effectiveness of standard of care treatments for Alzheimer's disease. Data collected through the registry may be used to address a range of research questions and use cases, including but not limited to: Evaluating the effectiveness and safety of commercially available medications for the treatment of Alzheimer's disease, Providing information to support ongoing risk-benefit evaluation by drug manufacturers and regulators, Research related to drug utilization, disease burden, and unmet needs and Supporting post-authorization safety studies to generate evidence related to real world safety of medications used for the treatment of the disease(s) under study
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
- 是
入选标准
- •To be eligible to participate in this registry, an individual must meet all the following criteria (determined by the investigator):
- •Has been diagnosed with mild cognitive impairment (MCI), early symptomatic Alzheimer's disease, Alzheimer's disease, or dementia with clinical suspicion of Alzheimer's disease.
- •Subject is at least 18 years of age or older and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted at the time of enrollment.
- •Has care partner(s) willing to participate as a source of information who maintains regular contact with the subject (defined as at least ten hours per week), will accompany the subject to the clinic visits, has attained the legal age for consent under the applicable law of jurisdiction in which the research is being conducted at the time of consent, and is willing and able to provide informed consent as the care partner.
- •Subject has the ability to understand the purpose, risks, and voluntariness of Registry participation and is willing and able to provide informed consent
- •For US subjects only, must be willing and able to provide Personally Identifiable Information (full legal name, sex at birth, date of birth, home address zip/postal code, and social security number at a minimum).
- •Has been prescribed (and intends to initiate) a commercially available therapy for the treatment of Alzheimer's disease (or symptoms of Alzheimer's disease) (Eligible Medication) at the time of enrollment.
- •Note: Participation in the registry will not interfere with the standard of care provided by the subject's treating clinician. Investigators retain independent clinical judgment in managing patient care.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in the registry:
- •Is participating or planning to participate in a double-blind randomized clinical trial for a MCI or AD.
- •Has been previously treated with an ATT prior to enrollment into the registry
结局指标
主要结局
Alzheimer Disease Epidemiology and presentation
时间窗: Every 6 months for 10 years
The major clinical outcome include an assessment of the epidemiology of Alzheimer's Disease; to better understand the presentation and natural history.
Alzheimer Disease management, and outcomes
时间窗: Every 6 months for 10 years
The major clinical outcome include an assessment of the epidemiology of Alzheimer Disease; to better understand the management and outcomes.
次要结局
未报告次要终点