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Deep Cervical Lymphovenous Anastomosis for Severe Alzheimer's Disease (DCLVA-AD)

21 juni 2026 uppdaterad av: Rong Hu, MD, Southwest Hospital, China

A Single-arm, Prospective, Self-controlled Study on Efficacy and Safety of Deep Cervical Lymphovenous Anastomosis for Neurological Function in Patients With Severe Alzheimer's Disease

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

59

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Kina
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina, 400038
        • The First Affiliated Hospital of Army Medical University (Southwest Hospital)
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • 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.
  • No clinical improvement after more than 6 months of standardized drug treatment.
  • Have a designated study companion who signs informed consent, contacts the patient at least 10 hours per week and accompanies study visits.
  • Able to complete scale assessments and examinations independently or with companion assistance.
  • Voluntarily comply with study procedures, examinations and surgical treatment.
  • Patient or legal representative can sign written informed consent and abide by trial requirements.
  • Patients and families are informed of study purpose, expected efficacy and potential risks, and voluntarily provide biological samples and participate in the study.

Exclusion Criteria:

  • 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.
  • History of intracranial hemorrhage or craniocerebral trauma within recent 1 year.
  • Alcohol or drug abuse/dependence within recent 1 year.
  • Allergy to indocyanine green, gadolinium contrast agent, 18F-florbetapir or 18F-flortaucipir.
  • Contraindications for PET examination.
  • Other conditions judged by investigators unsuitable for enrollment.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Deep Cervical Lymphovenous Anastomosis plus Routine Treatment
All participants receive one-time bilateral deep cervical lymphovenous anastomosis under microsurgery with indocyanine green lymphatic tracing. Conventional anti-Alzheimer's drugs are maintained throughout the study. All outcomes are compared with pre-operation baseline.
Procedur: Deep Cervical Lymphovenous Anastomosis
A 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.
Övrig: Routine Treatment
Stable 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Sum of Boxes (CDR-SB) Total Score
Tidsram: Baseline (pre-operation), 12 months after surgery
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.
Baseline (pre-operation), 12 months after surgery

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Sum of Boxes (CDR-SB) Total Score
Tidsram: Baseline (pre-operation), 1 month and 6 months after surgery
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.
Baseline (pre-operation), 1 month and 6 months after surgery
Mini-Mental State Examination (MMSE) Score
Tidsram: Baseline (pre-operation), 1 month, 6 months and 12 months after surgery
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.
Baseline (pre-operation), 1 month, 6 months and 12 months after surgery
Zarit Burden Interview (ZBI) Score
Tidsram: Baseline (pre-operation), 1 month, 6 months and 12 months after surgery
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.
Baseline (pre-operation), 1 month, 6 months and 12 months after surgery
Amyloid-beta (Aβ) PET-CT Centiloid Value
Tidsram: Baseline (pre-operation), 12 months after surgery
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.
Baseline (pre-operation), 12 months after surgery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Southwest Hospital, China

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

30 september 2028

Avslutad studie (Beräknad)

30 september 2029

Studieregistreringsdatum

Först inskickad

21 juni 2026

Först inskickad som uppfyllde QC-kriterierna

21 juni 2026

Första postat (Faktisk)

25 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • KY2026120
  • (A)KY2024136 (Annan identifierare: Ethics Committee of the First Affiliated Hospital of the Army Medical University)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

IPD-planbeskrivning

Individual participant data (IPD) will not be shared externally. All participant data is stored and managed locally in compliance with Chinese medical data privacy regulations and hospital internal management rules.

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