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

Last updated: January 2, 2024
Sponsor: Fujian Medical University Union Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Dizzy/fainting Spells

Memory Loss

Low Blood Pressure (Hypotension)

Treatment

AM

Routine treatment

add-on high dose Astragalus

Clinical Study ID

NCT05647473
AM-AD
  • Ages 50-85
  • All Genders

Study Summary

Background: This pragmatic clinical trial aims to determine the efficacy and safety of add-on Astragalus for cognition and non- cognition in patients with of mild to moderate Alzheimer's disease complicated with orthostatic hypotension in orthostatic hypotension, elucidate the underlying mechanisms, identify related response predictors, and explore effective drug components.

Methods: This is an add-on, assessor-blinded, parallel, pragmatic, randomized controlled trial. At least 66 adults with mild to moderate Alzheimer's disease (AD) and OH aged >30 years will be recruited. Participants will be randomized in a 1:1:1 ratio to receive 24 weeks of routine care or add-on low dose Astragalus or high dose Astragalus group. The primary efficacy outcome will be measured by the Alzheimer's Disease Assessment Scale-Cognitive Subscale, Chinese version. Secondary efficacy outcome assessment will include neuropsychological tests, blood pressure, plasma biomarkers, multimodal electroencephalograms, and neuroimaging. Safety outcome measures will include physical examinations, vital signs, electrocardiography, laboratory tests (such as hematologic and blood chemical tests), and adverse event records.

Eligibility Criteria

Inclusion

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 bloodpressure 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: 14points < 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 greaterthan 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-Vfor the diagnosis of dementia comply with the National Institute on Aging -Alzheimer's Association "Very likely AD" (National Institute of Aging-Alzheimer'sAssociation, 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 stablecaregiver, accompany to attend the visit.
  10. The basic treatment of AD before enrollment remained unchanged, and if long-term usersneeded to use it steadily for more than 4 weeks before randomization,the dose was keptas stable as possible during the study. Such drugs include: cholinesterase inhibitorsand diamantine.

Exclusion

Exclusion Criteria: The exclusion criteria will be as follows:

  1. MRI showed significant focal lesions, including one of the following: a. There weremore than 2 infarcts with a diameter greater than 2cm; b. Infarcts in key areas suchas 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 cognitiveimpairment; Mental and neurological retardation is present; Presence of malignanttumor
  5. The modified Hachinski Ischemia Scale (m-HIS) score was ≥ 4 points.
  6. Patients who refuse or have MRI or EEG contraindications (pacemakers, coronary andperipheral arterial stents, Metal implants, claustrophobia, or severe visual orhearing impairment), refusing to draw blood
  7. Pregnant or lactating patients;
  8. Patients who have participated in other clinical studies within the past 3 months

Study Design

Total Participants: 66
Treatment Group(s): 4
Primary Treatment: AM
Phase: 2
Study Start date:
February 20, 2024
Estimated Completion Date:
May 30, 2025

Connect with a study center

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350000
    China

    Active - Recruiting

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