Study Safety and Efficacy of Deep Brain Stimulation (DBS) and Cervical Deep Lymphoid-venous Anastomosis (LVA) in Alzheimer's Disease

Официальное название

Study Safety and Efficacy of Deep Brain Stimulation (DBS) and Cervical Deep Lymphoid-venous Anastomosis (LVA) in Patients With Severe Alzheimer's Disease

Обзор

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.

Вмешательства

• Процедура Deep Brain Stimulation, DBS
  Deep brain stimulation (DBS) is performed after preoperative MRI and CT images are fused in a planning system to determine the target and trajectory. Under general anesthesia, electrodes are precisely implanted into the fornix or nucleus basalis of Meynert using a stereotactic frame or neurosurgical robot. The electrodes are inserted through a burr hole in the patient's skull and connected to a pulse generator placed subcutaneously in the chest. Optimal stimulation parameters for Alzheimer's dis
• Процедура Deep cervical lymphatic-venous anastomosis, LVA
  Cervical deep lymphaticovenous anastomosis (LVA) microsurgically connects deep cervical lymphatic vessels to adjacent veins, promoting drainage of brain-derived amyloid-β and tau into the venous system and potentially alleviating Alzheimer's disease symptoms. The minimally invasive neck procedure involves small incisions and high-magnification suturing of lymphatics and veins with ultra-fine (11-0 or 12-0) sutures, creating multiple anastomoses to enhance brain lymphatic outflow.
• Препарат Recognized pharmacological treatments for AD.
  Patients in the medication group received only the currently recognized pharmacological treatments for AD, including Memantine Hydrochloride and Donepezil.

Первичные конечные точки

• The Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog) [Срок оценки: 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) score [Срок оценки: changes of baseline and month 1,month 3, month 6, month 9, month 12 month 15, month 18 after surgery]
• Clinical Dementia Rating(CDR) score [Срок оценки: changes of baseline and month 1, month 3, month 6, month 9, month 12, month 15, month 18 after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Chinese PLA General Hospital — Пекин

Идентификаторы

NCT: NCT07094438 · ChinaPLAGH_CNT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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