Long-Term Real-World Comparative Effectiveness of Donanemab Plus Usual Care Versus Usual Care Alone in US Patients With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-REAL US)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6,250
- 试验地点
- 1
- 主要终点
- Time to First Increase in Dependence Level Above Baseline (as derived from the Dependence Scale [DS])
研究概览
简要总结
The main purpose of this study is to evaluate the long-term effectiveness of donanemab plus usual care versus usual care alone in participants with early symptomatic AD. The study will employ a prospective, observational cohort design with participant management resembling real-world practice to the greatest extent possible via prospective assessments and linkage to historical and prospective electronic health records. The study will last about 273 weeks and may include up to 28 visits.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants
- •are under care for presumed mild cognitive impairment (MCI) or mild dementia stage of AD (Note: neither a biomarker-based diagnosis of AD nor a diagnosis in electronic health records [EHR] is required prior to screening)
- •have a Telephone Interview for Cognitive Status (TICS) score of ≥21
- •presence of amyloid beta (Aβ) pathology supported by biomarker results (e.g., P-tau, amyloid positron emission tomography (PET), and/or cerebrospinal fluid [CSF]). (Note: A historical biomarker may be used for eligibility if performed within 12 months of study entry)
- •have a reliable study partner who is in frequent contact with the participant and will be available by telephone at designated times (every 6 months), and
- •have EHR data available for linkage and are willing to allow access to EHR data for the duration of the study.
排除标准
- •have prior ischemic or hemorrhagic stroke(s) with an inability to independently perform any one or more basic activities of daily living (ADLs) (i.e., walking, transferring, eating, bathing, dressing, or toileting). (Note: mixed dementias with amyloid pathology are permitted)
- •have current or recent serious or unstable illness (other than AD) that, in the investigator's opinion, could interfere with the ability of the participant or study partner to complete the study (e.g., life expectancy of less than 36 months, requirement for long-term (>12 months) institutional-level care, serious psychiatric illness, etc.)
- •are currently enrolled or intend to enroll in a clinical trial of another investigational product, and
- •have contraindications to donanemab, magnetic resonance imaging (MRI), or amyloid PET tracers. (Donanemab group only).
研究组 & 干预措施
Donanemab Group + Usual Care
Participants will receive open-label (unblinded) donanemab intravenously (IV) and Usual Care
干预措施: Usual Care (Drug)
Usual Care Group
Participants will receive usual care.
干预措施: Usual Care (Drug)
Donanemab Group + Usual Care
Participants will receive open-label (unblinded) donanemab intravenously (IV) and Usual Care
干预措施: Donanemab (Drug)
结局指标
主要结局
Time to First Increase in Dependence Level Above Baseline (as derived from the Dependence Scale [DS])
时间窗: Up to 5 Years
The DS is a caregiver-reported outcome assessing the need for daily in-home or institutional assistance by participants with AD. The DS is completed as a structured interview with a knowledgeable caregiver or study partner. The scale is composed of 13 items evaluating progressive needs for assistance. The total score ranges from 0 to 15, with higher scores indicating a greater degree of dependence on external support.
次要结局
- Time to Loss of Independence (Dependence Level ≥3 as derived from the DS) for the Subgroup of Participants with Dependence Level <3 at Baseline(Up to 5 Years)
- Time to Institutionalization from Baseline for the Subgroup of Participants not Institutionalized at Baseline(Up to 5 Years)
- Change from Baseline Over Time (Semi-Annually) in DS Total Score(Baseline, Up to 5 Years)
- Change from Baseline Over Time (Assessed Semi-Annually) in Functional Assessment Questionnaire (FAQ) Total Score(Baseline, Up to 5 Years)
- Change from Baseline Over Time (Assessed Yearly) in Neuropsychiatric Inventory (NPI-Q) Total Severity Score(Baseline, Up to 5 Years)
- Change from Baseline Over Time (Assessed Yearly) in Zarit Burden Inventory-short version (ZBI-12) total score(Baseline, Up to 5 Years)
- Change from Baseline Over Time (Assessed Semi-Annually) in Living Situation as Assessed by the Participant Lifestyle Questionnaire (P-LSQ)(Baseline, Up to 5 Years)
- Change from Baseline Over Time (Assessed Semi-Annually) in Home Healthcare as Assessed by the P-LSQ(Baseline, Up to 5 Years)
- Change from Baseline Over Time (Assessed Semi-Annually) in Driving Status as Assessed by the P-LSQ(Baseline, Up to 5 Years)