Study Safety and Efficacy of Deep Brain Stimulation (DBS) and Cervical Deep Lymphoid-venous Anastomosis (LVA) in Alzheimer's Disease

Last updated: July 28, 2025
Sponsor: Chinese PLA General Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Recognized pharmacological treatments for AD.

Deep Brain Stimulation, DBS

Deep cervical lymphatic-venous anastomosis, LVA

Clinical Study ID

NCT07094438
ChinaPLAGH_CNT
  • Ages 40-80
  • All Genders

Study 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

Inclusion Criteria:

  • Meeting the diagnostic criteria for dementia formulated by the National Institute onAging-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 subjectand their legal guardian.

Exclusion

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, ordrug-induced psychosis.

  • Severe internal diseases, currently usingrespiratory/cardiovascular/anticonvulsant/psychotropic drugs, or clinicallysignificant gastrointestinal, renal, hepatic, respiratory, infectious, endocrine, orcardiovascular 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, frontotemporaldementia, or infectious dementia;

  • Any other condition deemed by the investigator as unsuitable for the study

Study Design

Total Participants: 98
Treatment Group(s): 3
Primary Treatment: Recognized pharmacological treatments for AD.
Phase: 1
Study Start date:
January 01, 2025
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • Chinese PLA General Hospital

    Beijing,
    China

    Active - Recruiting

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