Study Safety and Efficacy of Deep Brain Stimulation (DBS) and Cervical Deep Lymphoid-venous Anastomosis (LVA) in Patients With Severe Alzheimer's Disease
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- The Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog)
研究概览
简要总结
To investigate the safety of deep brain stimulation (DBS) and cervical deep lymphoid-venous anastomosis (LVA) in the treatment of severe Alzheimer's disease (AD); to investigate the effectiveness of DBS and LVA in the treatment of severe AD, i.e., effects of deep brain stimulation on cognitive function, emotion and life quality in patients with severe AD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting the diagnostic criteria for dementia formulated by the National Institute on Aging-Alzheimer's Association (NIA-AA).
- •Clinical Dementia Rating (CDR) score of 3 points.
- •Ability to ambulate independently or with the aid of a walker/cane.
- •Adequate visual and auditory capacity to cooperate with examinations and treatment.
- •Voluntary participation with written informed consent provided by both the subject and their legal guardian.
排除标准
- •Pre-existing abnormal brain structure (e.g., tumor, cerebral infarction, hydrocephalus, or intracranial hemorrhage).
- •Comorbidity with other neurological disorders such as multiple sclerosis, epilepsy, or Parkinson's disease.
- •Psychiatric disorders: e.g., anxiety, depression, other affective disorders, or drug-induced psychosis.
- •Severe internal diseases, currently using respiratory/cardiovascular/anticonvulsant/psychotropic drugs, or clinically significant gastrointestinal, renal, hepatic, respiratory, infectious, endocrine, or cardiovascular diseases, cancer, alcoholism, or substance addiction.
- •Severe auditory or visual impairment.
- •Clinical comorbidities with life expectancy <2 years.
- •History of cranial surgery.
- •Contraindications to MRI or transcranial alternating current stimulation (tACS) (e.g., cardiac pacemaker, post-deep brain stimulation surgery).
- •Eczema or sensitive skin.
- •Familial Alzheimer's disease.
- •Other types of dementia: e.g., vascular dementia, Lewy body dementia, frontotemporal dementia, or infectious dementia;
- •Any other condition deemed by the investigator as unsuitable for the study
研究组 & 干预措施
DBS arm
Patients in the DBS group underwent deep brain electrode implantation, followed by cranial MRI and CT to verify the accuracy of electrode placement.
干预措施: Deep Brain Stimulation, DBS (Procedure)
LVA arm
Patients in the LVA group underwent LVA surgery, followed by cervical ultrasound and CT to assess the anastomosis.
干预措施: Deep cervical lymphatic-venous anastomosis, LVA (Procedure)
medication arm
Patients in the medication group received drug therapy only, without undergoing surgery.
干预措施: Recognized pharmacological treatments for AD. (Drug)
结局指标
主要结局
The Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog)
时间窗: changes of baseline and month 1, month 3, month 6, month 9, month 12, month 15, month 18 after surgery
The Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog) scale is widely used for evaluating the severity of AD. ADAS-Cog consists of 12 components including word recall, naming, command, constructional praxis, ideational praxis, orientation, word recognition, remembering test instructions, spoken language ability, word finding difficulty, comprehension of oral language, and attention. The ADAS-Cog assesses multiple cognitive domains including memory, language, praxis, and orientation. ADAS-Cog score ranges from 0-75, with higher scores indicating more severe cognitive impairment.
Mini-Mental State Examination (MMSE) score
时间窗: changes of baseline and month 1,month 3, month 6, month 9, month 12 month 15, month 18 after surgery
Mini-Mental State Examination (MMSE) is one of the most influential cognitive screening tools worldwide. It consists of five dimensions including orientation (10 points), registration (3 points), attention and calculation (5 points), recall (3 points) and language and praxis (9 points). Educational attainment level-related dementia classification: illiterate: 5 points ≤ MMSE score ≤16 points; primary school: 8 points ≤ MMSE score ≤ 20 points; junior high school and above: 10 points ≤ MMSE score ≤ 24 points.
Clinical Dementia Rating(CDR) score
时间窗: changes of baseline and month 1, month 3, month 6, month 9, month 12, month 15, month 18 after surgery
The Clinical Dementia Rating(CDR) is 5-point scale used to characterize six domains (memory, orientation, judgment \& problem solving, community affairs, home \& hobbies and personal care) of the cognitive and functional performance of the aged (in particular AD patients). Patients are rated on dementia severity: 0 = normal, 0.5 = questionable dementia; 1 = mild dementia; 2 = moderate dementia; 3 = severe dementia.
次要结局
未报告次要终点
研究者
Zhiqi Mao
Principal Investigator
Chinese PLA General Hospital