NCT07094438 · Phase 1 · RECRUITING
Study Safety and Efficacy of Deep Brain Stimulation (DBS) and Cervical Deep Lymphoid-venous Anastomosis (LVA) in Alzheimer's Disease
This early trial tests two surgical procedures in people with severe Alzheimer's: deep brain stimulation, which uses implanted electrodes, and a lymphatic-to-vein bypass in the neck. Researchers are looking at safety first, then effects on thinking, mood and quality of life. It is a Phase 1 trial, meaning an early look at safety, not proven or approved.
You may qualify if
- 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.
You're excluded if
- 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-07-30