Cognitive Neurology Unit's Anti-amyloid Monoclonal Antibodies for the Treatment of Alzheimer's Disease Clinical Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- To Identify Any Associations Between Side Effects And Patient Characteristics
研究概览
简要总结
A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's Disease
详细描述
Alzheimer's disease (AD) is a neurodegenerative disorder associated with brain deposition of extracellular amyloid and intracellular tau. It causes progressive cognitive impairment, especially memory, and is invariably fatal. Currently, there is no effective treatment for AD. A new and promising method involves the use of anti-amyloid-beta monoclonal antibodies (anti-amyloid mAbs) to reduce amyloid accumulation in brain. There are currently two anti-amyloid mABs, aducanumab and lecanemab, approved by the FDA under FDA's "accelerated approval" pathway. However, so far there is only a single phase 3 study that unequivocally demonstrates clinical efficacy of anti-amyloid mAB therapy1. This study is designed to help determine the therapeutic benefit of anti-amyloid mABs therapy by treating AD patients in our clinic with anti-amyloid mABs and measuring cognitive impairment and functional outcomes over the course of the treatment period and beyond. This study has 4 specific aims.
SPECIFIC AIM 1: TO CREATE A CNU ANTI-AMYLOID MONOCLONAL ANTIBODY REGISTRY
SPECIFIC AIM 2: TO DETERMINE WHETHER ANTI-AMYLOID MABs SLOW COGNITIVE AND FUNCTIONAL DECLINE
SPECIFIC AIM 3: TO IDENTIFY ANY ASSOCIATIONS BETWEEN SIDES EFFECTS AND PATIENT CHARACTERISTICS
SPECIFIC AIM 4: TO ESTABLISH THE TIME COURSE OF CLINICAL BENEFITS
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
- 50 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •o Patient meets clinical criteria for mild cognitive impairment or early dementia from Alzheimer's disease
- •Patient has evidence of cognitive impairment on neuropsychological testing
- •Patient has not progressed to the moderate stage of dementia based on neuropsychological testing or clinical judgement
- •Amyloid PET imaging and/or CSF analysis consistent with Alzheimer's disease
- •Amyloid PET imaging positive
- •CSF p-Tau/Abeta42 ration >0.023 and ABeta42 < 1027**
- •3T MRI in past 6 months
- •Patient has a care partner
- •Patient under the care of an appropriate BI-Lahey amyloid clinic
- •Patient is on a stable medication regimen
排除标准
- •o Recent stroke or suspected TIA in the past year
- •Pregnancy
- •Active autoimmune or immunological disease
- •Systemic treatment with immunosuppressants, immunoglobulins, or monoclonal antibodies or their derivatives
- •Bleeding disorder with Plts < 50,000 or INR > 1.5
- •On warfarin, heparin, or DOAC
- •On dual antiplatelet therapy
- •Non Alzheimer disease cause of dementia/MCI
- •ApoE e4 homozygote
研究组 & 干预措施
Lecanemab
Patients with Alzheimer Disease receiving anti-amyloid mAb therapy at the BIDMC
干预措施: Lecanemab (Drug)
结局指标
主要结局
To Identify Any Associations Between Side Effects And Patient Characteristics
时间窗: 30 months
This study is a prospective, registry-based, single unit, observational study comparing anti-amyloid mAb therapy patient demographics to clinical outcomes.
To Determine Whether Anti-Amyloid Mabs Slow Cognitive And Functional Decline
时间窗: 30 months
This study is a prospective, registry-based, single unit, observational study comparing clinical outcome in patients receiving anti-amyloid mAb therapy to historical norms.
To Establish The Time Course Of Clinical Benefits
时间窗: 30 months
This study is a prospective, registry-based, single unit, observational study examining anti-amyloid mAb therapy patient clinical outcomes and adverse effects over time.
次要结局
未报告次要终点
研究者
Daniel Press
Chief, Cognitive Neurology Unit
Beth Israel Deaconess Medical Center