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Lymphaticovenous anastomosis (LVA) is a microsurgical technique that involves anastomosing fine lymphatic vessels with adjacent veins to reestablish lymphatic drainage pathways. It is used in the treatment of lymphedema-related conditions and is characterized by minimal invasiveness and rapid recovery. Based on findings from animal studies, some physicians in China have attempted deep cervical lymphatic-venous anastomosis to improve intracranial lymphatic drainage in patients with Alzheimer's disease (AD). Most studies, including those from our center, have observed early postoperative improvements in various domains such as mood, memory, executive function, and communication abilities in the majority of patients. However, these symptomatic improvements are not sustained. The reasons for the early improvements remain unclear. Are they due to enhanced lymphatic drainage resulting from the surgery itself, or are they attributable to other factors such as anesthetic effects, vascular release, or modulation of sympathetic nerves? Therefore, it is necessary to conduct a randomized controlled trial with a sham surgery group to clarify the causes of early clinical symptom improvements. Based on this, this project aims to carry out a prospective, single-center, randomized double-blind controlled study to evaluate whether the early symptomatic improvements following deep cervical LVA in AD patients are attributable to the surgical intervention itself or to other aspects of the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LVA group | Experimental | patients will receive lymphaticovenous anastomosis |
|
| Sham group | Sham Comparator | patients will undergo the LVA surgical procedure without performing the lymphaticovenous anastomosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deep cervical lymphaticovenous anastomosis | Procedure | patients will receive deep cervical lymphaticovenous anastomosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Montreal Cognitive Assessment (MoCA) score | MoCA ranges from 0 to 30, with higher score meaning better outcome | 4±1 days |
| Changes in Mini-mental State Examination (MMSE) score | MMSE ranges from 0 to 30, with higher score meaning better outcome | 4±1 days |
| Changes in Barthel index (BI) | BI ranges from 0 to 100, with higher score meaning better outcome | 4±1 days |
| Changes in Clinician's Interview-Based Impression of Change-plus caregiver input (CIBIC-plus) | CIBIC-plus ranges from 1 to 7, with higher score meaning worse outcome | 4±1 days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Montreal Cognitive Assessment (MoCA) score | MoCA ranges from 0 to 30, with higher score meaning better outcome | 90±7 days; 180±15 days; 270±20 days |
| Changes in Mini-mental State Examination (MMSE) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, General Hospital of Northern Theater Command | Recruiting | Shenyang | 110016 | China |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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MMSE ranges from 0 to 30, with higher score meaning better outcome
| 90±7 days; 180±15 days; 270±20 days |
| Changes in Barthel index (BI) | BI ranges from 0 to 100, with higher score meaning better outcome | 90±7 days; 180±15 days; 270±20 days |
| Changes in Clinician's Interview-Based Impression of Change-plus caregiver input (CIBIC-plus) | CIBIC-plus ranges from 1 to 7, with higher score meaning worse outcome | 90±7 days; 180±15 days; 270±20 days |
| Severe adverse events | Perioperative period |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |