Deep Cervical Lymphatic Venous Anastomosis in Treatment of Alzheimer's Disease: A Multicenter, Prospective, Registry (CLEAN-AD Registry)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 814
- 试验地点
- 1
- 主要终点
- The change of Clinical Dementia Rating-Sum of Boxes score at 12th months after surgery
研究概览
简要总结
This multicenter, prospective registry is to evaluate the efficacy and safety of deep cervical lymphatic venous anastomosis (DC-LVA) in reduing the clinical dementia rating-sum of boxes (CDR-SB) score of Alzheimer's Disease (AD) patients at 12 months after surgery in the real-world.
详细描述
Alzheimer's Disease (AD) is a common neurodegenerative disorder affecting the elderly population. Global health data estimates that there are 50 million AD patients worldwide, and this number may triple to 150 million cases by 2050. Anti-amyloid β (Aβ) monoclonal antibodies have emerged as disease-modifying therapies for preclinical or mild AD, but the majority of candidate agents have failed to demonstrate clinical efficacy. A series of case studies has suggested the efficacy of deep cervical lymphatic venous anastomosis (DC-LVA) in AD patients, however, there is currently a lack of large-sample cohort study in the real-world.
The primary purpose of this study is to evaluate the efficacy and safety of deep cervical lymphatic venous anastomosis (DC-LVA) in improve the cognitive function of AD patients at 12 months, and to identify subgroups asscociated with the treatment outcome.
This cohort is a multicenter, prospective, registry. A total of 814 patients received DC-LVA treatment in 40 centers from China will be enrolled. Face to face interviews will be made at baseline, 7 days (or hospital discharge), 3 months ± 7 days, 6months ± 15 days, 12 month ± 15 days, 18 month ± 15 days, and 24 month ±15 days.
The change of clinical dementia rating-sum of boxes (CDR-SB) score, Neuropsychiatric Inventory (NPI) score, Activities of Daily Living (ADCS-ADL) score, Caregiver Burden (ZCI-AD) score, Mini-Mental State Examination (MMSE) score, AD Assessment Scale-Cognitive Subscale (ADAS-cog13) score at 3, 6, 12, 18, 24 months, and the change of brain amyloid burden evaluated by Aβ PET-CT centiloid value at 12 months will be measured.
The changes of CDR-SB score will be analyzed using a repeated measures mixed-effects model. Least squares means will be used to estimate the levels at each time point, and the mean difference with 95% confidence intervals will be calculated. Safety outcomes will be summarized using counts/percentages. Adverse events and serious adverse events will be summarized.
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
- 否
入选标准
- •Age ≥ 18 years, male or famale.
- •Diagnosed with AD according to the NIA-AA criteria.
- •Patients who have received DC-LVA treatment;
- •Signed informed consent (by the subject or their relative, and caregiver)
排除标准
- •Severe neurological deficits in limb movement, language, vision, hearing, or consciousness, or any condition that the investigator determines may prevent the completion of cognitive function assessments.
- •The subject lacks a stable and reliable caregiver to accompany with them during entire study follow-up visits.
结局指标
主要结局
The change of Clinical Dementia Rating-Sum of Boxes score at 12th months after surgery
时间窗: From baseline to 12th months after surgery
The change of Clinical Dementia Rating-Sum of Boxes score (CDR-SB, 0-18 score, higher scores mean a worse outcome)
The incidence of perioperative complications within 7 days after surgery
时间窗: From baseline to 7th days after surgery
The incidence of perioperative complications
次要结局
- The Change of Clinical Dementia Rating-Sum of Boxes score(From baseline to 3th, 6th, 18th, 24th months after surgery)
- The Change of Neuropsychiatric Inventory Score(From baseline to 3th, 6th, 12th,18th, 24th months after surgery)
- The Change of Alzheimer's Disease Assessment Scale-Activity of Daily Living score(From baseline to 3th, 6th, 12th, 18th, 24th months after surgery)
- The Change of Zarit Caregiver Interview of Alzheimer's Disease Score(From baseline to 3th, 6th, 12th,18th, 24th months after surgery)
- The Change of Mini-Mental State Examination Score(From baseline to 3th, 6th, 12th, 18th, 24th months after surgery)
- The Change of Alzheimer's Disease Assessment Scale Cognitive Score(From baseline to 3th, 6th, 12th,18th, 24th months after surgery)
- The Change of Aβ PET-CT Centiloid value(From baseline to 12th months after surgery)
研究者
yilong Wang
Professor
Beijing Tiantan Hospital