Deep Cervical Lymphovenous Anastomosis for Severe Alzheimer's Disease
ConditionAlzheimer s Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorSouthwest Hospital, China
About this trial
Alzheimer's disease (AD) is a severe neurodegenerative disease with heavy social burden. Current drugs cannot reverse disease progression. Brain glymphatic system and meningeal lymphatic dysfunction lead to impaired clearance of Aβ and Tau protein, which is an important pathogenesis of AD. Deep cervical lymphovenous anastomosis (DCLVA) can improve intracranial lymphatic drainage, promote the clearance of toxic proteins, and improve neurological function. This is a single-arm, prospective, self-controlled study to enroll 59 patients with severe AD (MMSE \< 10). All patients receive bilateral DCLVA plus routine medication. The primary endpoint is change of CDR-SB score at 12 months post-operation. Secondary endpoints include MMSE, ZBI scores and Aβ PET-CT Centiloid value. This study aims to verify the efficacy and safety of DCLVA for severe AD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Meet the 2011 NIA-AA clinical diagnostic criteria for probable Alzheimer's disease dementia and the 2018 NIA-AA research framework biomarker criteria for AD.
Aged 50 to 80 years (inclusive) at the time of signing informed consent.
Severe cognitive dysfunction: Mini-Mental State Examination (MMSE) score < 10 points.
Progressive cognitive deterioration for more than 6 months reported by patient or caregiver.
Disqualifiers
Severe central nervous system diseases (other than AD) that affect cognitive function or study compliance.
Severe/unstable systemic diseases (cardiovascular, hepatic, renal, respiratory, endocrine, hematological, psychiatric diseases); life expectancy less than 24 months.
Surgical contraindications: severe coagulation disorders, severe -cardiopulmonary diseases (myocardial infarction/respiratory failure within recent 30 days); severe liver damage (ALT/AST > 3 times upper limit of normal); severe renal insufficiency (eGFR < 30ml/min).
Severe primary mental disorders (other than AD) that interfere with efficacy evaluation and cognitive assessment.
Trial design
Design model
Single group
Treatments tested in this trial
Deep Cervical Lymphovenous Anastomosis
Procedure/SurgeryA one-time microsurgical procedure performed under general anesthesia. Indocyanine green (ICG) is injected for intraoperative lymphatic vessel tracing under a fluorescent surgical microscope. Lymphatic vessels or lymphatic flaps are anastomosed to cervical veins via end-to-side or end-to-end technique to improve intracranial lymphatic drainage. No additional surgical interventions are applied.
Routine Treatment
Other interventionStable administration of standard drugs for Alzheimer's disease, including cholinesterase inhibitors and/or NMDA receptor antagonists, following clinical guidelines. Participants continue their original medication regimen throughout the whole study period without dose adjustment or drug switching.
Treatment groups
59 Participants
are divided into 1 treatment groupGroup A: Deep Cervical Lymphovenous Anastomosis plus Routine TreatmentExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Sum of Boxes (CDR-SB) Total Score
The CDR-SB total score ranges from 0 to 18 points. Higher scores indicate more severe cognitive impairment and functional decline. This outcome evaluates the change of total CDR-SB score in patients with severe Alzheimer's disease after receiving deep cervical lymphovenous anastomosis, to assess the therapeutic effect on neurological function.
Time frame
Baseline (pre-operation), 12 months after surgerySecondary outcomes
1
Sum of Boxes (CDR-SB) Total Score
The CDR-SB total score ranges from 0 to 18 points. Higher scores indicate more severe cognitive impairment and functional decline. This outcome evaluates the change of total CDR-SB score in patients with severe Alzheimer's disease after receiving deep cervical lymphovenous anastomosis, to assess the therapeutic effect on neurological function.
Time frame
Baseline (pre-operation), 1 month and 6 months after surgery2
Mini-Mental State Examination (MMSE) Score
MMSE total score ranges from 0 to 30. Higher scores represent better cognitive function. A score below 10 indicates severe cognitive impairment. This measure assesses changes in overall cognitive status after surgical intervention.
Time frame
Baseline (pre-operation), 1 month, 6 months and 12 months after surgery3
Zarit Burden Interview (ZBI) Score
ZBI total score ranges from 0 to 88. Higher scores mean heavier caregiver burden. It is used to evaluate the impact of treatment on the psychological and life burden of patients' caregivers.
Time frame
Baseline (pre-operation), 1 month, 6 months and 12 months after surgery4
Amyloid-beta (Aβ) PET-CT Centiloid Value
Centiloid value reflects the level of cerebral amyloid-beta deposition. Detect and compare the difference of brain Aβ deposition between baseline and 12 months post-operation.
Time frame
Baseline (pre-operation), 12 months after surgerySponsors and contacts
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Source ClinicalTrials.gov
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