Deep brain stimulation and neck lymphatic‑venous bypass for severe Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.