Menu
Recruiting NCT07094438

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

Phase I Interventional Alzheimer Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deep Brain Stimulation, DBS, Deep cervical lymphatic-venous anastomosis, LVA, Recognized pharmacological treatments for AD..
Who it may be relevant to
Registry conditions: Alzheimer Disease. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure 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
  • Procedure 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.
  • Drug Recognized pharmacological treatments for AD.
    Patients in the medication group received only the currently recognized pharmacological treatments for AD, including Memantine Hydrochloride and Donepezil.

Primary outcome measures

  • The Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog) [Time frame: 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 [Time frame: 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 [Time frame: changes of baseline and month 1, month 3, month 6, month 9, month 12, month 15, month 18 after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Chinese PLA General Hospital — Beijing

Identifiers

NCT: NCT07094438 · ChinaPLAGH_CNT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗