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Study Safety and Efficacy of Deep Brain Stimulation (DBS) and Cervical Deep Lymphoid-venous Anastomosis (LVA) in Alzheimer's Disease
NCT07094438 · Chinese PLA General Hospital
In plain English
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Official title
Study Safety and Efficacy of Deep Brain Stimulation (DBS) and Cervical Deep Lymphoid-venous Anastomosis (LVA) in Patients With Severe Alzheimer's Disease
About this study
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
Study design
Enrollment target: 98 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-01-01
Estimated completion: 2027-07
Last updated: 2025-07-30
Interventions
Procedure: Deep Brain Stimulation, DBSProcedure: Deep cervical lymphatic-venous anastomosis, LVADrug: Recognized pharmacological treatments for AD.
Primary outcomes
- • The Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog) (changes of baseline and month 1, month 3, month 6, month 9, month 12, month 15, month 18 after surgery)
- • Mini-Mental State Examination (MMSE) score (changes of baseline and month 1,month 3, month 6, month 9, month 12 month 15, month 18 after surgery)
- • Clinical Dementia Rating(CDR) score (changes of baseline and month 1, month 3, month 6, month 9, month 12, month 15, month 18 after surgery)
Sponsor
Chinese PLA General Hospital · other
Contacts & investigators
ContactZhiqi Mao, Ph.D · contact · markmaoqi@126.com · 8618910155994
InvestigatorZhiqi Mao, Ph.D · principal_investigator, Chinese PLA General Hospita
All locations (1)
Chinese PLA General HospitalRecruiting
Beijing, China