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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05578443
• Other study ID #: AD-AS
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2022
• Est. completion date: July 30, 2025

Study information

• Verified date: July 2023
• Source: Fujian Medical University Union Hospital
• Contact: Xiaodong Pan
• Phone: 86218341
• Email: pxd77316[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 30, 2025
• Est. primary completion date: July 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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:

1. 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.

2. unable to have magnetic resonance imaging (MRI) or electroencephalogram (EEG).

3. use of health foods, supplements, and medicines that may affect cognitive function,

4. have severe visual and/or hearing impairment.

5. during pregnancy or lactation

6. participation in other clinical studies within the past 3 months. -

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Astragalus
Astragalus tablets 20g, warm water to drink, once a day, take for 1 year, during which routine treatment should also be carried out.

Behavioral:
• Routine treatment
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.

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University Union Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline MoCA scores at 3 months	The Montreal Cognitive Assessment (MoCA)	Baseline vs 3 months after treatment.
Secondary	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.]
Secondary	The plasma concentration of Cycloastragenol (µg/ml)		Time Frame: 1 hour after treatment.
Secondary	Change from the baseline plasma a-synuclein levels (ng/ml) at 3 months		Baseline vs 3 months after treatment.
Secondary	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
Secondary	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
Secondary	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
Secondary	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 ? pulse pressure + diastolic pressure.	Baseline vs 3 months after treatment