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
Eligibility Criteria
Inclusion
Inclusion Criteria: The inclusion criteria will be as follows:
- Male or female aged ≥50 years and ≤85 years
- 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.
- 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: 14points < total score of MMSE <24 points, 0.5≤CDR≤2 points, and the total score of HAMD (24-item version) ≤20 points
- Brain magnetic resonance imaging shows the degree of hippocampal atrophy is greaterthan or equal to grade 1
- The modified Hachinski Ischemia Scale (m-HIS) score was < 4 points
- 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).
- There are no obvious positive signs in nervous system examination;
- The subjects have the ability of reading, writing and communication, have a stablecaregiver, accompany to attend the visit.
- 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:
- 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
- Patients who have taken other Chinese medicine preparations in the past three months
- Allergy or contraindication of astragalus
- There are other neurological diseases that can cause brain dysfunction or cognitiveimpairment; Mental and neurological retardation is present; Presence of malignanttumor
- The modified Hachinski Ischemia Scale (m-HIS) score was ≥ 4 points.
- 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
- Pregnant or lactating patients;
- 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
ChinaActive - Recruiting
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