Deep Cervical Lymphovenous Anastomosis for Severe Alzheimer's Disease (DCLVA-AD)
21 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
59
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Rong Hu, MD
- Número de teléfono: +8602368765911
- Correo electrónico: huchrong@tmmu.edu.cn
Copia de seguridad de contactos de estudio
- Nombre: Jingyu Chen, MD
- Número de teléfono: +8602368765911
- Correo electrónico: 283686484@qq.com
Ubicaciones de estudio
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, Porcelana, 400038
- The First Affiliated Hospital of Army Medical University (Southwest Hospital)
-
Contacto:
- Jingyu Chen, MD
- Número de teléfono: +8602368765911
- Correo electrónico: 283686484@qq.com
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
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.
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sum of Boxes (CDR-SB) Total Score
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sum of Boxes (CDR-SB) Total Score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
30 de septiembre de 2028
Finalización del estudio (Estimado)
30 de septiembre de 2029
Fechas de registro del estudio
Enviado por primera vez
21 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
21 de junio de 2026
Publicado por primera vez (Actual)
25 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KY2026120
- (A)KY2024136 (Otro identificador: Ethics Committee of the First Affiliated Hospital of the Army Medical University)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .