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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Enrolling; Phase 1

Conditions: Alzheimer Disease

Treatments: Drug: Recognized pharmacological treatments for AD.; Procedure: Deep Brain Stimulation, DBS; Procedure: Deep cervical lymphatic-venous anastomosis, LVA

Study type: Interventional

Funder types: Other

Identifiers

NCT07094438

ChinaPLAGH_CNT

Details and patient eligibility

About

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.

Enrollment: 98 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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98 participants in 3 patient groups

DBS arm

Experimental group

Description:

Patients in the DBS group underwent deep brain electrode implantation, followed by cranial MRI and CT to verify the accuracy of electrode placement.

Treatment:

Procedure: Deep Brain Stimulation, DBS

LVA arm

Experimental group

Description:

Patients in the LVA group underwent LVA surgery, followed by cervical ultrasound and CT to assess the anastomosis.

Treatment:

Procedure: Deep cervical lymphatic-venous anastomosis, LVA

medication arm

Active Comparator group

Description:

Patients in the medication group received drug therapy only, without undergoing surgery.

Treatment:

Drug: Recognized pharmacological treatments for AD.