Deep brain stimulation and neck lymphatic‑venous bypass for severe Alzheimer's disease
Study Safety and Efficacy of Deep Brain Stimulation (DBS) and Cervical Deep Lymphoid-venous Anastomosis (LVA) in Patients With Severe Alzheimer's Disease
This project tests deep brain stimulation plus a neck lymphatic‑venous bypass to see if they are safe and help thinking, mood, and quality of life in people with severe Alzheimer's disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07094438 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional trial combines surgical deep brain stimulation (DBS) with cervical deep lymphatic‑venous anastomosis (LVA) in people with severe Alzheimer's disease to examine safety and preliminary effects. Participants may continue recognized pharmacological treatments while undergoing DBS implantation and a neck LVA procedure, followed by structured postoperative monitoring and scheduled assessments. The primary aim is to document safety and tolerability, with secondary measures tracking changes in cognitive function, mood, and daily quality of life. The single‑site trial enrolls patients with a Clinical Dementia Rating of 3 who can provide written consent together with their legal guardian.
Who should consider this trial
Good fit: Adults with severe Alzheimer's disease (CDR = 3) who can ambulate (with or without a walker/cane), have adequate vision and hearing to cooperate with exams, and provide written informed consent alongside their legal guardian are ideal candidates.
Not a fit: Patients with major structural brain abnormalities, other neurologic or psychiatric disorders, or significant uncontrolled internal medical illnesses are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could offer a new surgical option to improve cognition, mood, and quality of life for people with severe Alzheimer's disease.
How similar studies have performed: Small prior trials of DBS in Alzheimer's have reported mixed results and limited cognitive benefit, while cervical lymphatic‑venous anastomosis for Alzheimer's is a novel, largely untested surgical approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing
- Chinese PLA General Hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Zhiqi Mao, Ph.D — Chinese PLA General Hospita
- Study coordinator: Zhiqi Mao, Ph.D
- Email: markmaoqi@126.com
- Phone: 8618910155994
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.