Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This research aims to observe the efficacy and safety of surgery compared with traditional medical treatment for moderate to severe dementia in Alzheimer's disease. This is a prospective multicenter RCT clinical research, involving a total of 3 research centers.Patients diagnosed with Alzheimer's disease accompanied by moderate to severe cognitive dysfunction in these three hospitals from January 2025 to January 2027 were included. This research is expected to recruit a total of 186 patients with moderate to severe Alzheimer's disease.93patients received conventional medical treatment, Deep cervical lymphatic-venous anastomosis was performed in 93 patients.Comprehensively evaluate the efficacy and safety of the patients within 48 weeks after treatment.
Alzheimer's disease is a degenerative disorder of the central nervous system characterized by progressive cognitive dysfunction and behavioral impairment. At present, the treatment strategies for Alzheimer's disease include drug therapy, non-drug therapy and some emerging treatment methods. However, clinical evidence has confirmed that the effects of these treatment measures are limited. In recent years, Some neurosurgeons in China have begun to attempt to improve the disease progression of severe Alzheimer's disease through the innovative microscopic surgical method of deep jugular lymphovenous anastomosis. The therapeutic principle is Lymph node reconstruction is carried out using microsurgical techniques to improve the lymphatic circulation and return of the brain, accelerate the excretion of pathological proteins, the metabolic products of the brain, thereby delaying the degenerative changes of the brain and the progression of Alzheimer's disease. To verify the above assumption, this study will collaborate with a total of three institutions, namely Ruijin Hospital, Luwan Branch and Wuxi Branch. It is estimated that 186 patients with moderate to severe dementia of Alzheimer's disease will be included. They were randomly divided into the surgical treatment group (93 cases) and the traditional medical treatment group (93 cases). Cognitive function assessment, PETMR imaging examination, cerebrospinal fluid/blood testing and quality-adjusted life years were analyzed respectively at the 1st week, 4th week, 12th week, 24th week and 48th week after conservative treatment or surgery. To observe the efficacy and safety of surgery compared with traditional medical treatment for moderate to severe dementia in Alzheimer's disease.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical treatment | Experimental | Deep cervical lymphatic-venous anastomosis |
|
| Internal medicine conservative treatment | Placebo Comparator | Donepezil drug ,5-10mg,qd,po. All patients stopped taking cognitive-enhancing drugs and marketed therapeutic drugs such as ginkgo, high-dose vitamin E, lecithin, estrogen, non-steroidal anti-inflammatory drugs, Memegan, etc. after enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep cervical lymphatic-venous anastomosis | Procedure | Lymph node reconstruction was carried out using microsurgical techniques,improve cerebral lymphatic circulation and return, accelerate the excretion of pathological proteins, the metabolic products of the brain, from the brain. This is to delay the degenerative changes of the brain and the progression of Alzheimer's disease. |
| Measure | Description | Time Frame |
|---|---|---|
| ADAS-cog score | The improvement of 4 points by ADAS-cog is used as the judgment criterion for the clinical therapeutic effect, Compare the remission rates between the experimental group (surgery) and the control group (medication). | baseline,48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Imaging data | PET-MRI labeled with specific tracers shows the changes in amyloid protein or tau deposition, Quantify and statistically analyze the changes between the two groups. | From the first week to the 48th week |
| Cerebrospinal fluid examination |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yijun Cheng, Doc | Contact | 15021058538 | cyj12574@rjh.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yijun Cheng, Doc | Ruijin Hospital | Principal Investigator |
| Hanbing Shang | Ruijin Hospital | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Donepezil drug treatment | Drug | All patients stopped taking cognitive-enhancing drugs after enrollment, and marketed therapeutic drugs include ginkgo biloba, high-dose vitamin E, lecithin, estrogen, non-steroidal anti-inflammatory drugs, memegan, etc. |
|
Test the Alzheimer's disease markers such as amyloid protein or tau deposition in the cerebrospinal fluid between the two groups, count the changes between the two groups.
| From the first week to the 48th week |
| Markers of Alzheimer's disease in the blood | Test the changes of Alzheimer's disease markers such as amyloid protein in the blood between the two groups,count the changes between the two groups. | From the first week to the 48th week |
| Surgery-related adverse reactions | The occurrence of complications:such as postoperative bleeding,Peripheral nerve injury,Lymphatic vessel leakage,Cardiovascular and cerebrovascular events, etc. | From the first week to the 48th week |
| Quality-Adjusted Life Year | It is a health outcome evaluation index that comprehensively considers survival time and quality of life. The survival time and quality of life of the intervention group and the medication group were compared. The calculation method is Survival Time (years) × Health Utility Value, The health utility value is a quality weight reflecting a specific health status(1 indicates complete health, 0 indicates death, and a negative value indicates a state worse than death). The utility values of patients under different health conditions were evaluated through the Quality of life assessment scale, an assessment should be conducted every six months after treatment. Multiply the duration of each health state by the corresponding utility value. Then accumulate to obtain the Quality-Adjusted Life Year score. | From the first week to the 48th week |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided