NCT07094438 Study Safety and Efficacy of Deep Brain Stimulation (DBS) and Cervical Deep Lymphoid-venous Anastomosis (LVA) in Alzheimer's Disease
| NCT ID | NCT07094438 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Chinese PLA General Hospital |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 98 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 98 participants in total. It began in 2025-01-01 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Zhiqi Mao, Ph.D
PRINCIPAL INVESTIGATOR
Chinese PLA General Hospita
Frequently Asked Questions
Who can join the NCT07094438 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07094438 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07094438 currently recruiting?
Yes, NCT07094438 is actively recruiting participants. Contact the research team at markmaoqi@126.com for enrollment information.
Where is the NCT07094438 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07094438 clinical trial?
NCT07094438 is sponsored by Chinese PLA General Hospital. The principal investigator is Zhiqi Mao, Ph.D at Chinese PLA General Hospita. The trial plans to enroll 98 participants.
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