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

• Status: Recruiting
• Trial end date: 2025-05-30
• Target enrollment: 0
• Participant gender: All

Summary

Background: The presence of hypotension in adults increases their risk of cognitive impairment. Recent big data studies showed that add-on Astragalus membranaceus (AM) can effectively improve the state of hypotension. The effectiveness of add-on AM in improving cognitive function in hypotension has not been established. Therefore, this study aims to determine the efficacy and safety of add-on AM treatment in improving cognitive function among hypotension, reveal the underlying mechanisms, and further explore the effective drug components through network pharmacology.

Methods/design: This is an add-on, assessor-blind, parallel, pragmatic randomized controlled clinical trial. At least 68 hypotensive adults aged 30 or older will be recruited. Participants will be randomized 1:1 to receive 24 weeks of add-on astragalus or routine treatment. Primary efficacy outcome will the changes in the MOCA score, second efficacy outcomes will include changes in neuropsychological tests, blood pressure, plasma biomarkers, multimodal electroencephalogram and neuroimaging. Safety outcomes will include physical examinations, vital signs, electrocardiography, laboratory tests (hematologic tests and blood chemical values), and adverse events (AEs) records.

Discussion: Considering the possible physical, social, financial, and psychological consequences of cognitive impairment, we hope to provide insights into the effects of add-on AM on cognitive function in hypotension. It is projected that add-on AM will significantly delay the development of cognitive impairment and improve cognitive function compared to the use of routine treatment alone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujian Medical University Union Hospital

Criteria

Inclusion Criteria:

• Patients who have all of the following will be included in this study:

1. age over 30 years;

2. Montreal Cognitive Assessment (MoCA) test score<26;

3. hypotension. We will define mean systolic BP readings below 110 mmHg for men and 100 mmHg for women as hypotension

Exclusion Criteria:

• Patients who have one of the following will excluded from this trial:

1. secondary hypotension;

2. diagnosis of dementia according to the 4th Edition of the Diagnostic and Statistical Manual of Mental Disorders26;

3. definite hypersensitivity or contraindication to the study medications;

4. 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;

5. who refuse or who have contraindications to have magnetic resonance imaging (MRI) or electroencephalogram (EEG) (cardiac pacemaker, coronary and peripheral artery stents, metal implants, claustrophobia, severe visual and/or hearing impairment);

6. use psychoactive drugs, medication affecting the cardiovascular system, or such with known interactions with AM;

7. during pregnancy or lactation;

8. participation in other clinical studies within the past 3 months.