Using Astragalus Membranaceus to improve cognitive function in Alzheimer's patients

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

This study is testing if adding Astragalus Membranaceus to the usual treatment can help improve thinking skills in people with mild-to-moderate Alzheimer's Disease.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 50 Years to 80 Years
• Sex: All
• Sponsor: Fujian Medical University Union Hospital (Academic / other)
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT05578443 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of Astragalus Membranaceus as an add-on treatment for patients with mild-to-moderate Alzheimer's Disease. Participants will receive either 10g or 20g of Astragalus alongside their routine treatment. The study aims to assess cognitive improvements and identify predictors of response to the intervention. By evaluating the effects of Astragalus on cerebral blood flow and brain cell protection, the trial seeks to provide insights into its potential benefits for cognitive function in Alzheimer's patients.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 to 85 with mild to moderate Alzheimer's Disease and specific cognitive impairment criteria.

Not a fit: Patients with severe Alzheimer's Disease or those who do not meet the cognitive impairment criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance cognitive function and quality of life for patients with Alzheimer's Disease.

How similar studies have performed: While the effects of Astragalus have been explored in vitro, this specific clinical application is novel and has not been extensively tested in similar studies.

Eligibility criteria

Inclusion Criteria:

The inclusion criteria will be as follows:

1. Male or female aged ≥50 years and ≤85 years
2. Memory loss for at least 6 months, with a progressive worsening trend Patients with mild or moderate disease degree, that is, the total score of MMSE: 14 points \< total score of MMSE \<24 points, 0.5≤CDR≤2 points, and the total score of HAMD (24-item version) ≤20 points
3. Brain magnetic resonance imaging shows the degree of hippocampal atrophy is greater than or equal to grade 1
4. The modified Hachinski Ischemia Scale (m-HIS) score was \< 4 points
5. The criteria described by the diagnostic and statistical manual of mental disorder-V for the diagnosis of dementia comply with the National Institute on Aging - Alzheimer's Association "Very likely AD" (National Institute of Aging-Alzheimer's Association, 2011).
6. There are no obvious positive signs in nervous system examination;
7. The subjects have the ability of reading, writing and communication, have a stable caregiver, accompany to attend the visit.
8. The basic treatment of AD before enrollment remained unchanged, and if long-term users needed to use it steadily for more than 4 weeks before randomization,the dose was kept as stable as possible during the study. Such drugs include: cholinesterase inhibitors.

Exclusion Criteria:

The exclusion criteria will be as follows:

1. MRI showed significant focal lesions, including one of the following: a. There were more than 2 infarcts with a diameter greater than 2cm; b. Infarcts in key areas such as the thalamus, hippocampus, entorhinal cortex, parorhinal cortex, angular gyrus, cortex, and other subcortical gray matter nuclei; c. White matter lesion Fazekas Scale ≥3
2. Patients who have taken other Chinese medicine preparations in the past three months
3. Allergy or contraindication of astragalus
4. There are other neurological diseases that can cause brain dysfunction or cognitive impairment; Mental and neurological retardation is present; Presence of malignant tumor
5. The modified Hachinski Ischemia Scale (m-HIS) score was ≥ 4 points. Patients who refuse or have MRI or EEG contraindications (pacemakers, coronary and peripheral arterial stents, Metal implants, claustrophobia, or severe visual or hearing impairment), refusing to draw blood
6. Pregnant or lactating patients;
7. Patients who have participated in other clinical studies within the past 3 months

Where this trial is running

Fuzhou, Fujian

• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)

Study contacts

• Study coordinator: Xiaodong Pan

Conditions Alzheimer's Disease