Efficacy, Safety and Response Predictors of Astragalus Membranaceus on the Improvement of Cognitive Function in Mild-to-Moderate Alzheimer's Disease

NCT05578443 | Unknown Phase 2

• 1 other identifier: AD-AS
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Alzheimer's disease (AD), the most common cause of dementia, is characterized by cognitive impairment, mental and behavioural abnormalities, and social dysfunction. Current treatments can only delay the progression of AD, not cure it completely. In vitro studies have shown that Astragalus has toxic effects such as anti-hypoxia injury of nerve cells, anti-free radical damage, anti-excitatory amino acids, etc. It can be used to expand cerebral vessels, increase cerebral blood flow, improve cerebral microcirculation, protect brain cells, and repair damaged brain cells. However, the clinical effects of add-on Astragalus in improving cognition in these patients remain unclear. Therefore, this pragmatic clinical trial aims to determine the efficacy and safety of add-on Astragalus in improving cognition in patients with AD

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• The primary efficacy outcome measure will be the absolute change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale, Chinese version score between baseline and week 48.

  The Alzheimer's Disease Assessment Scale-Cognitive Subscale, Chinese version scale scores range from 0 to 75, with higher scores indicating better.

  Participants will be followed up for 48 weeks after baseline.

Secondary Outcomes (25)

• The absolute scores change in the Rey-Osterrieth Complex Figure Test [ROCF] recall score between baseline and week 48.

  Participants will be followed up for 48 weeks after baseline

• The absolute scores change in the ROCF-copy score between baseline and week 48

  Participants will be followed up for 48 weeks after baseline.

• The absolute scores change in the Clock-Drawing Test score between baseline and week 48.

  Participants will be followed up for 48 weeks after baseline

• The absolute scores change in the Trail Making Test-A score between baseline and week 48

  Participants will be followed up for 48 weeks after baseline.

• The absolute scores change in the Digit Span Forward score between baseline and week 48.

  Participants will be followed up for 48 weeks after baseline.

Other Outcomes (5)

• Whether the participants' vital signs were normal.

  Participants will be followed up for 48 weeks after baseline.

• Whether the participants' Electrocardiograms were normal.

  Participants will be followed up for 48 weeks after baseline.

• Whether the participants' Liver function were normal.

  Participants will be followed up for 48 weeks after baseline.

Study Arms (3)

10g Astragalus membranaceus

EXPERIMENTAL

Drug: 10g Astragalus; Behavioral: Routine treatment

Routine treatment

EXPERIMENTAL

Behavioral: Routine treatment

20g Astragalus membranaceus

EXPERIMENTAL

Behavioral: Routine treatment; Drug: 20g Astragalus

Interventions

10g Astragalus DRUG

Astragalus tablets 10g, warm water to drink, once a day, take for 1 year, during which routine treatment should also be carried out.

10g Astragalus membranaceus

Routine treatment BEHAVIORAL

Limit water and sodium intake. Raise the head of the bed. Standardized amount of exercise. Low temperature diet and small meals. Avoid alcohol, coffee and dehydration. The treatment lasted for 3 months.

10g Astragalus membranaceus; 20g Astragalus membranaceus; Routine treatment

20g Astragalus DRUG

Astragalus tablets 20g, warm water to drink, once a day, take for 1 year, during which routine treatment should also be carried out.

20g Astragalus membranaceus

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged ≥50 years and ≤85 years
• 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: 14 points \< 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 greater than 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-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).
• There are no obvious positive signs in nervous system examination;
• The subjects have the ability of reading, writing and communication, have a stable caregiver, accompany to attend the visit.
• 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.

You may not qualify if:

• 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
• 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 cognitive impairment; Mental and neurological retardation is present; Presence of malignant tumor
• The modified Hachinski Ischemia Scale (m-HIS) score was ≥ 4 points. 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
• Pregnant or lactating patients;
• Patients who have participated in other clinical studies within the past 3 months

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Xiaodong Pan

CONTACT

86218341; pxd77316@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 13, 2022
• Study Start: May 1, 2024
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)