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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 |
|---|---|---|---|
| Astragalus membranaceus | Experimental |
| |
| Routine treatment | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Astragalus Membranaceus Root | Drug | Astragalus tablets 15g, 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 Clinical Dementia Rating | Clinical Dementia Rating scale scores range from 0 to 18, with higher scores indicating worse. | Participants were followed up for 24 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 24 | The ROCF scale scores range from 0 to 36, with higher scores indicating better. | Participants were followed up for 24 weeks after baseline. |
| The absolute scores change in the Rey-Osterrieth Complex Figure Test-copy score between baseline and week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350000 | 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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| ID | Term |
|---|---|
| C027492 | Huang Qi |
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The ROCF copy scale scores range from 0 to 36, with higher scores indicating better. |
| Participants were followed up for 24 weeks after baseline. |
| The absolute scores change in the Trail Making Test-A score between baseline and week 24 | The Trail Making Test-A scores range from 0 to 25, with higher scores indicating better. | Participants were followed up for 24 weeks after baseline. |
| The absolute scores change in the Digit Span Forward score between baseline and week 24 | TheDigit Span Forward score scores range from 0 to 10, with higher scores indicating better. | Participants were followed up for 24 weeks after baseline. |
| The absolute scores change in the Trail Making Test-B score between baseline and week 24 | The Trail Making Test-B scores range from 0 to 25, with higher scores indicating better. | Participants were followed up for 24 weeks after baseline. |
| The absolute scores change in the Digit Span Backward score between baseline and week 24 | The Digit Span Forward score scores range from 0 to 9, with higher scores indicating better. | Participants were followed up for 24 weeks after baseline. |
| The absolute scores change in the Verbal Fluency Test score between baseline and week 24 | The Verbal Fluency Test score scores range from 0 to 14, with higher scores indicating better. | Participants were followed up for 24 weeks after baseline. |
| The absolute scores change in the Hamilton Anxiety Scale score between baseline and week 24 | The Hamilton Anxiety Scale score scores range from 0 to 56, with higher scores indicating worse. | Participants were followed up for 24 weeks after baseline. |
| The absolute scores change in the Hamilton Depression Scale score between baseline and week 24 | The Hamilton Anxiety Scale score scores range from 0 to 96, with higher scores indicating worse | Participants were followed up for 24 weeks after baseline. |
| The absolute change in the blood pressure between baseline and week 24 | To observe the changes of orthostatic blood pressure in patients | Participants were followed up for 24 weeks after baseline. |
| The absolute change in the level of plasma β-amyloid40 (ng/ml) between baseline and week 24 | Amyloid is one of the main biomarkers of dementia | Participants were followed up for 24 weeks after baseline. |
| The absolute change in the level of plasma β-amyloid42 (ng/ml) between baseline and week 24 | Amyloid is one of the main biomarkers of dementia | Participants were followed up for 24 weeks after baseline. |
| The absolute change in the level of plasma glial fibrillary acidic protein (ng/ml) between baseline and week 24 | Glial fibrillary acidic protein is one of the main biomarkers of dementia | Participants were followed up for 24 weeks after baseline. |
| The absolute change in the level of plasma neurofilament light chain (ng/ml) between baseline and week 24 | Neurofilament light chain is one of the main biomarkers of dementia | Participants were followed up for 24 weeks after baseline. |
| The absolute change in the level of plasma hyper-phosphorylated tau-181 (ng/ml) between baseline and week 24 | Neurofilament light chain is one of the main biomarkers of dementia | Participants were followed up for 24 weeks after baseline. |
| The absolute change in the neurite density index between baseline and week 24 | Neurite density index, range from 0-1, is the main indicator of neurite-oriented diffusion and density imaging (NODDI),with higher scores indicating better | Participants were followed up for 24 weeks after baseline. |
| The absolute change in the orientation dispersion index between baseline and week 24 | Orientation dispersion indexrange from 0-1, is the main indicator of neurite-oriented diffusion and density imaging (NODDI) ,with higher scores indicating better. | Participants were followed up for 24 weeks after baseline. |
| The absolute change in the isotropic volume fraction between baseline and week 24 | Isotropic volume fraction, range from 0-1, is the main indicator of neurite-oriented diffusion and density imaging (NODDI), with higher scores indicating worse . | Participants were followed up for 24 weeks after baseline. |
| The absolute change in thickness, between baseline and week 24. | Cortical thickness is the main indicator of grey matter.Cortical thickness was obtained by analyzing structural MRI using the freesurfer. | Participants were followed up for 24 weeks after baseline. |
| The absolute change in volume, between baseline and week 24 | Volume, is the main indicator of brain structure.Volume was obtained by analyzing structural MRI using thevoxel-based morphometry | Participants were followed up for 24 weeks after baseline. |
| The absolute change in delta, between baseline and week 24 | Delta, is the main indicator of the cerebral cortex activity | Participants were followed up for 24 weeks after baseline. |
| The absolute change in theta, between baseline and week 24 | Theta, is the main indicator of the cerebral cortex activity(range from 4-7.5Hz) | Participants were followed up for 24 weeks after baseline. |
| The absolute change in alpha, between baseline and week 24 | Alpha, is the main indicator of the cerebral cortex activity(range from 7.5-14Hz) | Participants were followed up for 24 weeks after baseline. |
| The absolute change in beta1, between baseline and week 24 | Beta1, is the main indicator of the cerebral cortex activity(range from 14-20Hz) | Participants were followed up for 24 weeks after baseline. |
| The absolute change in beta2, between baseline and week 24 | Beta2, is the main indicator of the cerebral cortex activity(range from 20-30Hz) | Participants were followed up for 24 weeks after baseline. |
| The absolute change in gamma, between baseline and week 24 | Gamma, is the main indicator of the cerebral cortex activity(range from 30-50Hz) | Participants were followed up for 24 weeks after baseline. |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |