Deep Cervical Lymphatic Venous Anastomosis in the Treatment of Alzheimer's Disease (CLEAN-AD)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorBeijing Tiantan Hospital

About this trial

This multicenter, prospective, open-label, blinded-endpoint, randomized controlled trial is to evaluate the efficacy and safety of deep cervical lymphatic venous anastomosis (DC-LVA) plus usual care versus usual care in reduing the score of clinical dementia rating-sum of boxes (CDR-SB) at 12 months in patients with moderate-to-severe Alzheimer's Disease (AD).

Eligibility criteria

Qualifiers

Age 50-80 years, male or female.

Diagnosed with AD according to NIA-AA criteria.

Moderate-to-severe AD dementia, defined as Clinical Dementia Rating Scale Global Score (CDR-GS) ≥1.

Mini-Mental State Examination (MMSE) score 10-20.

Disqualifiers

Any neurological condition other than AD that may affect cognitive function, including stroke, Parkinson's disease, epilepsy, intracranial tumors or space-occupying lesions, traumatic brain injury, intracranial infections, metabolic encephalopathy, etc.

Other causes of dementia, including vascular dementia, hereditary cerebral small vessel disease, vitamin deficiency, or any other etiology leading to dementia.

Previous evidence of severe stenosis (≥70%) in the middle cerebral artery and/or internal carotid artery.

Presence of primary psychiatric disorders (such as schizophrenia, schizoaffective disorder, major depressive disorder, or bipolar disorder) rather than psychiatric symptoms caused by AD.

Trial design

Treatments tested in this trial

  • DC-LVA treatment plus usual care
  • Usual care

Treatment groups

376 Participants
are divided into 2 treatment groups

Sponsors and collaborators