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| ID | Type | Description | Link |
|---|---|---|---|
| (A)KY2024136 | Other Identifier | Ethics Committee of the First Affiliated Hospital of the Army Medical University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep Cervical Lymphovenous Anastomosis plus Routine Treatment | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Cervical Lymphovenous Anastomosis | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (pre-operation), 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (pre-operation), 1 month and 6 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rong Hu, MD | Contact | +8602368765911 | huchrong@tmmu.edu.cn | |
| Jingyu Chen, MD | Contact | +8602368765911 | 283686484@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Army Medical University (Southwest Hospital) | Chongqing | Chongqing Municipality | 400038 | China |
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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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D060825 | Cognitive Dysfunction |
| D019636 | Neurodegenerative Diseases |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| Routine Treatment | Other | 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. |
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| 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. | Baseline (pre-operation), 1 month, 6 months and 12 months after surgery |
| 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. | Baseline (pre-operation), 1 month, 6 months and 12 months after surgery |
| 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. | Baseline (pre-operation), 12 months after surgery |
| D019965 |
| Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |