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Alzheimer's disease (AD), the most common cause of dementia, is characterized by cognitive impairment, mental and behavioural abnormalities, and social dysfunction. Current treatments can only delay the progression of AD, not cure it completely. In vitro studies have shown that Astragalus has toxic effects such as anti-hypoxia injury of nerve cells, anti-free radical damage, anti-excitatory amino acids, etc. It can be used to expand cerebral vessels, increase cerebral blood flow, improve cerebral microcirculation, protect brain cells, and repair damaged brain cells. However, the clinical effects of add-on Astragalus in improving cognition in these patients remain unclear. Therefore, this pragmatic clinical trial aims to determine the efficacy and safety of add-on Astragalus in improving cognition in patients with AD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10g Astragalus membranaceus | Experimental |
| |
| Routine treatment | Experimental |
| |
| 20g Astragalus membranaceus | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10g Astragalus | Drug | Astragalus tablets 10g, warm water to drink, once a day, take for 1 year, during which routine treatment should also be carried out. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy outcome measure will be the absolute change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale, Chinese version score between baseline and week 48. | The Alzheimer's Disease Assessment Scale-Cognitive Subscale, Chinese version scale scores range from 0 to 75, with higher scores indicating better. | Participants will be followed up for 48 weeks after baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| The absolute scores change in the Rey-Osterrieth Complex Figure Test [ROCF] recall score between baseline and week 48. | The ROCF scale scores range from 0 to 36, with higher scores indicating better. | Participants will be followed up for 48 weeks after baseline |
| The absolute scores change in the ROCF-copy score between baseline and week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Whether the participants' vital signs were normal. | Safety outcome | Participants will be followed up for 48 weeks after baseline. |
| Whether the participants' Electrocardiograms were normal. | Safety outcome |
Inclusion Criteria:
The inclusion criteria will be as follows:
Exclusion Criteria:
The exclusion criteria will be as follows:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaodong Pan | Contact | 86218341 | pxd77316@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | 350000 | China |
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| Routine treatment | Behavioral | Limit water and sodium intake. Raise the head of the bed. Standardized amount of exercise. Low temperature diet and small meals. Avoid alcohol, coffee and dehydration. The treatment lasted for 3 months. |
|
| 20g Astragalus | Drug | Astragalus tablets 20g, warm water to drink, once a day, take for 1 year, during which routine treatment should also be carried out. |
|
The ROCF copy scale scores range from 0 to 36, with higher scores indicating better. |
| Participants will be followed up for 48 weeks after baseline. |
| The absolute scores change in the Clock-Drawing Test score between baseline and week 48. | The Clock-Drawing Test scale scores range from 0 to 5, with higher scores indicating better. | Participants will be followed up for 48 weeks after baseline |
| The absolute scores change in the Trail Making Test-A score between baseline and week 48 | The Trail Making Test-A scores range from 0 to 25, with higher scores indicating better. | Participants will be followed up for 48 weeks after baseline. |
| The absolute scores change in the Digit Span Forward score between baseline and week 48. | TheDigit Span Forward score scores range from 0 to 10, with higher scores indicating better. | Participants will be followed up for 48 weeks after baseline. |
| The absolute scores change in the Trail Making Test-B score between baseline and week 48. | The Trail Making Test-B scores range from 0 to 25, with higher scores indicating better. | Participants will be followed up for 48 weeks after baseline. |
| The absolute scores change in the Digit Span Backward score between baseline and week 48. | The Digit Span Forward score scores range from 0 to 9, with higher scores indicating better. | Participants will be followed up for 48 weeks after baseline. |
| The absolute scores change in the Verbal Fluency Test score between baseline and week 48. | The Verbal Fluency Test score scores range from 0 to 14, with higher scores indicating better. | Participants will be followed up for 48 weeks after baseline. |
| The absolute scores change in the Hamilton Anxiety Scale score between baseline and week 48 | The Hamilton Anxiety Scale score scores range from 0 to 56, with higher scores indicating worse. | Participants will be followed up for 48 weeks after baseline. |
| The absolute scores change in the Hamilton Depression Scale score between baseline and week 48. | The Hamilton Anxiety Scale score scores range from 0 to 96, with higher scores indicating worse. | Participants will be followed up for 48 weeks after baseline. |
| The absolute change in the blood pressure between baseline and week 48 | To observe the changes of orthostatic blood pressure in patients | Participants will be followed up for 48 weeks after baseline. |
| The absolute change in the level of plasma β-amyloid40 (ng/ml) between baseline and week 48. | Amyloid is one of the main biomarkers of dementia | Participants will be followed up for 48 weeks after baseline. |
| The absolute change in the level of plasma β-amyloid42 (ng/ml) between baseline and week 48 | Amyloid is one of the main biomarkers of dementia | Participants will be followed up for 48 weeks after baseline. |
| The absolute change in the level of plasma glial fibrillary acidic protein (ng/ml) between baseline and week 48 | Glial fibrillary acidic protein is one of the main biomarkers of dementia | Participants will be followed up for 48 weeks after baseline |
| The absolute change in the level of plasma neurofilament light chain (ng/ml) between baseline and week 48. | Neurofilament light chain is one of the main biomarkers of dementia | Participants will be followed up for 48 weeks after baseline. |
| The absolute change in the level of plasma hyper-phosphorylated tau-181 (ng/ml) between baseline and week 48 | Neurofilament light chain is one of the main biomarkers of dementia | Participants will be followed up for 48 weeks after baseline. |
| The absolute change in the P300 between baseline and week 48 | P300 is the main indicator of EEG, and its normal value range is between 320 and 420 | Participants will be followed up for 48 weeks after baseline. |
| The absolute change in the VP300 between baseline and week 48 | VP300 is the main indicator of EEG, and its normal value range is between 320 and 420. | Participants will be followed up for 48 weeks after baseline. |
| The absolute change in the MMN between baseline and week 48. | MMN is the main indicator of EEG, and its normal value range is between 100 and 210. | Participants will be followed up for 48 weeks after baseline. |
| The absolute change in the neurite density index between baseline and week 48 | Neurite density index is the main indicator of neurite-oriented diffusion and density imaging (NODDI) . | Participants will be followed up for 48 weeks after baseline. |
| The absolute change in the orientation dispersion index between baseline and week 48 | Orientation dispersion index is the main indicator of neurite-oriented diffusion and density imaging (NODDI) . | Participants will be followed up for 48 weeks after baseline. |
| The absolute change in the isotropic volume fraction between baseline and week 48 | Isotropic volume fraction is the main indicator of neurite-oriented diffusion and density imaging (NODDI) . | Participants will be followed up for 48 weeks after baseline. |
| The absolute change in surface area between baseline and week 48. | Surface area is the main indicator of voxel-based morphometry. | Participants will be followed up for 48 weeks after baseline. |
| The absolute change in thickness, between baseline and week 48. | Thickness, is the main indicator of voxel-based morphometry. | Participants will be followed up for 48 weeks after baseline. |
| The absolute change in volume, between baseline and week 48. | Volume, is the main indicator of voxel-based morphometry. | Participants will be followed up for 48 weeks after baseline. |
| Participants will be followed up for 48 weeks after baseline. |
| Whether the participants' Liver function were normal. | Safety outcome | Participants will be followed up for 48 weeks after baseline. |
| Whether the participants' kidney function were normal. | Safety outcome | Participants will be followed up for 48 weeks after baseline. |
| Severity of adverse events | Safety outcome | Participants will be followed up for 48 weeks after baseline. |
| 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 |
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