Efficacy, Safety and Response Predictors of Adjuvant Astragalus for Cognition in Orthostatic Hypotension

Launched by FUJIAN MEDICAL UNIVERSITY UNION HOSPITAL · Dec 4, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating whether adding Astragalus, a natural supplement, can help improve cognitive abilities in adults with mild to moderate Alzheimer's disease who also experience orthostatic hypotension (a drop in blood pressure when standing up). The study will involve at least 66 participants aged between 50 and 85 years, who will be randomly assigned to receive either standard care or one of two doses of Astragalus for 24 weeks. Researchers will assess participants' cognitive function, blood pressure, and overall health to see if Astragalus can safely enhance their condition.

To be eligible, participants must have noticeable memory loss for at least six months, experience a significant drop in blood pressure when standing, and show specific brain changes on MRI scans. Importantly, participants should be able to read and communicate and have a stable caregiver to accompany them. Throughout the study, participants can expect regular health check-ups and monitoring for any side effects. This trial aims to better understand how Astragalus might work and identify factors that predict who may benefit most from this treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• The inclusion criteria will be as follows:
• • 1. Male or female aged ≥50 years and ≤85 years
• • 2. A decrease in systolic blood pressure of 20 mm Hg or a decrease in diastolic blood pressure of 10 mm Hg within 3 minutes after standing.
• • 3. Memory loss for at least 6 months, with a progressive worsening trend
• • 4. 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
• • 5. Brain magnetic resonance imaging shows the degree of hippocampal atrophy is greater than or equal to grade 1
• • 6. The modified Hachinski Ischemia Scale (m-HIS) score was \< 4 points
• • 7. 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).
• • 8. There are no obvious positive signs in nervous system examination;
• • 9. The subjects have the ability of reading, writing and communication, have a stable caregiver, accompany to attend the visit.
• • 10. 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 and diamantine.
• 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.
• • 6. 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
• • 7. Pregnant or lactating patients;
• • 8. Patients who have participated in other clinical studies within the past 3 months