Study Safety and Efficacy of Deep Brain Stimulation (DBS) and Cervical Deep Lymphoid-venous Anastomosis (LVA) in Alzheimer's Disease
Recruiting · NCT07094438 · Interventional (participants receive a specific treatment) · Lead sponsor: Chinese PLA General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Deep Brain Stimulation, DBSDeep cervical lymphatic-venous anastomosis, LVARecognized pharmacological treatments for AD.
What this trial is 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.
Who can take part
Age range
40 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Chinese PLA General Hospital - Beijing, China