NCT05578443

Efficacy, Safety and Response Predictors of Astragalus Membranaceus on the Improvement of Cognitive Function in Mild-to-Moderate Alzheimer's Disease

Efficacy, Safety and Response Predictors of Astragalus Membranaceus on the Improvement of Cognitive Function in Mild-to-Moderate Alzheimer's Disease: a Randomized Controlled Trial Protocol

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Fujian Medical University Union Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	10g Astragalus	Astragalus tablets 10g, 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.
DRUG	20g Astragalus	Astragalus tablets 20g, warm water to drink, once a day, take for 1 year, during which routine treatment should also be carried out.

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-07-30
• Completion: 2025-07-30
• First posted: 2022-10-13
• Last updated: 2024-07-03

Locations

1 site across 1 country: China