Effect of Astragalus Membranaceus on the Improvement of Cognitive Function in Alzheimer's Disease

Study Overview
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Brief Summary
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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

Official Title
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Effect of Astragalus Membranaceus on the Improvement of Cognitive Function in Alzheimer's Disease: a Randomized Controlled Trial Protocol

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: Astragalus
* Behavioral: Routine treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:Participants with a clinical diagnosis of Alzheimer's disease. - Exclusion Criteria:Patients who have one of the following were excluded from this trial: being treated or history of serious diseases such as stroke or transient ischemic attack, claustrophobia, bipolar disorder, schizophrenia, seizures, drug or alcohol abuse, malignancy, renal failure and dialysis treatment, liver disease (hepatitis), renal disease. unable to have magnetic resonance imaging (MRI) or electroencephalogram (EEG). use of health foods, supplements, and medicines that may affect cognitive function, have severe visual and/or hearing impairment. during pregnancy or lactation participation in other clinical studies within the past 3 months. -

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Astragalus membranaceus<br> | Drug: Astragalus<br>* Astragalus tablets 20g, warm water to drink, once a day, take for 1 year, during which routine treatment should also be carried out.<br>|
| Experimental: Routine treatment<br> | Behavioral: Routine treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline MoCA scores at 3 months | The Montreal Cognitive Assessment (MoCA) | Baseline vs 3 months after treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline HRV (ms) at 3months | Heart rate variability (HRV) was calculated as the maximum bpm - minimum bpm | Baseline vs 3 months after treatment.] | 
| The plasma concentration of Cycloastragenol (μg/ml) |  | Time Frame: 1 hour after treatment. | 
| Change from the baseline plasma α-synuclein levels (ng/ml) at 3 months |  | Baseline vs 3 months after treatment. | 
| Change from baseline Vic at 3 months | The intra-cellular compartment (Vic) of the Neurite Orientation Dispersion and Density Imaging (NODDI) model represents diffusion within the axons and cells. | Baseline vs 3 months after treatment | 
| Change from baseline ODI at 3 months | NODDI models the dispersion of axonal fibers with the use of an Orientation Dispersion Index (ODI) | Baseline vs 3 months after treatment | 
| Change from baseline PAF (Hz) at 3 months | The alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band. | Baseline vs 3 months after treatment | 
| Change from baseline mean arterial pressure after 3 minutes of upright posture versus decubitus position (mmHg) at 3 months. | Mean arterial pressure was calculated as ⅓ pulse pressure + diastolic pressure. | Baseline vs 3 months after treatment |