Using Astragalus to improve cognition in Alzheimer's patients with orthostatic hypotension

Efficacy, Safety and Response Predictors of Adjuvant Astragalus for Cognition in Alzheimer Disease With Orthostatic Hypotension: an add-on, Assessor-blind, Pragmatic Randomized Controlled Trial

This study is testing if adding Astragalus to the usual care can help improve thinking skills in older adults with Alzheimer's who also have low blood pressure when standing up.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 50 Years to 85 Years
• Sex: All
• Sponsor: Fujian Medical University Union Hospital (Academic / other)
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT05647473 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of adding Astragalus to the routine care of patients aged 50 to 85 with mild to moderate Alzheimer's disease who also experience orthostatic hypotension. Participants will be randomly assigned to receive either routine care, low dose Astragalus, or high dose Astragalus for 24 weeks. The primary outcome will focus on cognitive improvement as measured by the Alzheimer's Disease Assessment Scale, while secondary outcomes will include various neuropsychological tests and physiological assessments. The study aims to identify predictors of response and explore the mechanisms behind Astragalus's effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 50 to 85 with mild to moderate Alzheimer's disease and a diagnosis of orthostatic hypotension.

Not a fit: Patients with severe Alzheimer's disease or those not experiencing orthostatic hypotension may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new adjunctive treatment option to enhance cognitive function in Alzheimer's patients suffering from orthostatic hypotension.

How similar studies have performed: While the use of Astragalus in cognitive disorders is not widely tested, similar herbal interventions have shown promise in other studies, making this approach potentially novel.

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

Where this trial is running

Fuzhou, Fujian

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

Study contacts

• Study coordinator: Xiaodong Pan

Conditions Orthostatic Hypotension; Alzheimer Disease