Alzheimer's DiseasePhase 2NCT05578443
Efficacy, Safety and Response Predictors of Astragalus Membranaceus on the Improvement of Cognitive Function in Mild-to-Moderate Alzheimer's Disease
A Phase 2 study testing 10g Astragalus, Routine treatment and 20g Astragalus in people with Alzheimer's Disease, run by Fujian Medical University Union Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- 10g Astragalus, Routine treatment and 20g Astragalus
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 30 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The inclusion criteria will be as follows:
- 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).
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- 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.
Who cannot join
- The exclusion criteria will be as follows:
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000
Xiaodong Pan, 86218341, xieheyb@163.com
About this study
Official title: Efficacy, Safety and Response Predictors of Astragalus Membranaceus on the Improvement of Cognitive Function in Mild-to-Moderate Alzheimer's Disease: a Randomized Controlled Trial Protocol
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
- Being tested
- 10g Astragalus, Routine treatment, 20g Astragalus
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10g AstragalusDrug
Astragalus tablets 10g, warm water to drink, once a day, take for 1 year, during which routine treatment should also be carried out.
Routine treatmentBehavioural
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.
20g AstragalusDrug
Astragalus tablets 20g, warm water to drink, once a day, take for 1 year, during which routine treatment should also be carried out.
| Study group | Role | What they receive |
|---|---|---|
| 10g Astragalus membranaceus | Experimental | Not described Receives: Drug: 10g Astragalus; Behavioral: Routine treatment |
| Routine treatment | Experimental | Not described Receives: Behavioral: Routine treatment |
| 20g Astragalus membranaceus | Experimental | Not described Receives: Behavioral: Routine treatment; Drug: 20g Astragalus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The ROCF scale scores range from 0 to 36, with higher scores indicating better.
Measured: Participants will be followed up for 48 weeks after baseline
The absolute scores change in the ROCF-copy score between baseline and week 48
The ROCF copy scale scores range from 0 to 36, with higher scores indicating better.
Measured: 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.
The Clock-Drawing Test scale scores range from 0 to 5, with higher scores indicating better.
Measured: 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
The Trail Making Test-A scores range from 0 to 25, with higher scores indicating better.
Measured: 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.
TheDigit Span Forward score scores range from 0 to 10, with higher scores indicating better.
Measured: Participants will be followed up for 48 weeks after baseline.
The absolute scores change in the Trail Making Test-B score between baseline and week 48.
The Trail Making Test-B scores range from 0 to 25, with higher scores indicating better.
Measured: Participants will be followed up for 48 weeks after baseline.
The absolute scores change in the Digit Span Backward score between baseline and week 48.
The Digit Span Forward score scores range from 0 to 9, with higher scores indicating better.
Measured: Participants will be followed up for 48 weeks after baseline.
The absolute scores change in the Verbal Fluency Test score between baseline and week 48.
The Verbal Fluency Test score scores range from 0 to 14, with higher scores indicating better.
Measured: Participants will be followed up for 48 weeks after baseline.
The absolute scores change in the Hamilton Anxiety Scale score between baseline and week 48
The Hamilton Anxiety Scale score scores range from 0 to 56, with higher scores indicating worse.
Measured: Participants will be followed up for 48 weeks after baseline.
The absolute scores change in the Hamilton Depression Scale score between baseline and week 48.
The Hamilton Anxiety Scale score scores range from 0 to 96, with higher scores indicating worse.
Measured: Participants will be followed up for 48 weeks after baseline.
The absolute change in the blood pressure between baseline and week 48
To observe the changes of orthostatic blood pressure in patients
Measured: Participants will be followed up for 48 weeks after baseline.
The absolute change in the level of plasma β-amyloid40 (ng/ml) between baseline and week 48.
Amyloid is one of the main biomarkers of dementia
Measured: Participants will be followed up for 48 weeks after baseline.
The absolute change in the level of plasma β-amyloid42 (ng/ml) between baseline and week 48
Amyloid is one of the main biomarkers of dementia
Measured: Participants will be followed up for 48 weeks after baseline.
The absolute change in the level of plasma glial fibrillary acidic protein (ng/ml) between baseline and week 48
Glial fibrillary acidic protein is one of the main biomarkers of dementia
Measured: Participants will be followed up for 48 weeks after baseline
The absolute change in the level of plasma neurofilament light chain (ng/ml) between baseline and week 48.
Neurofilament light chain is one of the main biomarkers of dementia
Measured: Participants will be followed up for 48 weeks after baseline.
The absolute change in the level of plasma hyper-phosphorylated tau-181 (ng/ml) between baseline and week 48
Neurofilament light chain is one of the main biomarkers of dementia
Measured: Participants will be followed up for 48 weeks after baseline.
The absolute change in the P300 between baseline and week 48
P300 is the main indicator of EEG, and its normal value range is between 320 and 420
Measured: Participants will be followed up for 48 weeks after baseline.
The absolute change in the VP300 between baseline and week 48
VP300 is the main indicator of EEG, and its normal value range is between 320 and 420.
Measured: Participants will be followed up for 48 weeks after baseline.
The absolute change in the MMN between baseline and week 48.
MMN is the main indicator of EEG, and its normal value range is between 100 and 210.
Measured: Participants will be followed up for 48 weeks after baseline.
The absolute change in the neurite density index between baseline and week 48
Neurite density index is the main indicator of neurite-oriented diffusion and density imaging (NODDI) .
Measured: Participants will be followed up for 48 weeks after baseline.
The absolute change in the orientation dispersion index between baseline and week 48
Orientation dispersion index is the main indicator of neurite-oriented diffusion and density imaging (NODDI) .
Measured: Participants will be followed up for 48 weeks after baseline.
The absolute change in the isotropic volume fraction between baseline and week 48
Isotropic volume fraction is the main indicator of neurite-oriented diffusion and density imaging (NODDI) .
Measured: Participants will be followed up for 48 weeks after baseline.
The absolute change in surface area between baseline and week 48.
Surface area is the main indicator of voxel-based morphometry.
Measured: Participants will be followed up for 48 weeks after baseline.
The absolute change in thickness, between baseline and week 48.
Thickness, is the main indicator of voxel-based morphometry.
Measured: Participants will be followed up for 48 weeks after baseline.
The absolute change in volume, between baseline and week 48.
Volume, is the main indicator of voxel-based morphometry.
Measured: Participants will be followed up for 48 weeks after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 May 2024
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578443
- Sponsor's protocol ID
- AD-AS
- Status last verified
- Jan 2024
- First submitted
- 11 Oct 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Response Predictors of Astragalus Membranaceus on the Improvement of Cognitive Function in Mild-to-Moderate Alzheimer's Disease: a Randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT05578443
- Acronym / sponsor ID
- AD-AS
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10g AstragalusAstragalus tablets 10g, warm water to drink, once a day, take for 1 year, during which routine treatment should also be carried out. | Drug | 10g Astragalus membranaceus |
| Routine treatmentLimit 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. | Behavioural | 10g Astragalus membranaceus, 20g Astragalus membranaceus, Routine treatment |
| 20g AstragalusAstragalus tablets 20g, warm water to drink, once a day, take for 1 year, during which routine treatment should also be carried out. | Drug | 20g Astragalus membranaceus |
Primary outcome
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.
Time frame: Participants will be followed up for 48 weeks after baseline.
The Alzheimer's Disease Assessment Scale-Cognitive Subscale, Chinese version scale scores range from 0 to 75, with higher scores indicating better.
25 secondary outcomes
The absolute scores change in the Rey-Osterrieth Complex Figure Test [ROCF] recall score between baseline and week 48.
Time frame: Participants will be followed up for 48 weeks after baseline
The absolute scores change in the ROCF-copy score between baseline and week 48
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Participants will be followed up for 48 weeks after baseline.
The absolute scores change in the Trail Making Test-B score between baseline and week 48.
Time frame: Participants will be followed up for 48 weeks after baseline.
The absolute scores change in the Digit Span Backward score between baseline and week 48.
Time frame: Participants will be followed up for 48 weeks after baseline.
The absolute scores change in the Verbal Fluency Test score between baseline and week 48.
Time frame: Participants will be followed up for 48 weeks after baseline.
The absolute scores change in the Hamilton Anxiety Scale score between baseline and week 48
Time frame: Participants will be followed up for 48 weeks after baseline.
The absolute scores change in the Hamilton Depression Scale score between baseline and week 48.
Time frame: Participants will be followed up for 48 weeks after baseline.
The absolute change in the blood pressure between baseline and week 48
Time frame: Participants will be followed up for 48 weeks after baseline.
The absolute change in the level of plasma β-amyloid40 (ng/ml) between baseline and week 48.
Time frame: Participants will be followed up for 48 weeks after baseline.
The absolute change in the level of plasma β-amyloid42 (ng/ml) between baseline and week 48
Time frame: Participants will be followed up for 48 weeks after baseline.
The absolute change in the level of plasma glial fibrillary acidic protein (ng/ml) between baseline and week 48
Time frame: Participants will be followed up for 48 weeks after baseline
The absolute change in the level of plasma neurofilament light chain (ng/ml) between baseline and week 48.
Time frame: Participants will be followed up for 48 weeks after baseline.
The absolute change in the level of plasma hyper-phosphorylated tau-181 (ng/ml) between baseline and week 48
Time frame: Participants will be followed up for 48 weeks after baseline.
The absolute change in the P300 between baseline and week 48
Time frame: Participants will be followed up for 48 weeks after baseline.
The absolute change in the VP300 between baseline and week 48
Time frame: Participants will be followed up for 48 weeks after baseline.
The absolute change in the MMN between baseline and week 48.
Time frame: Participants will be followed up for 48 weeks after baseline.
The absolute change in the neurite density index between baseline and week 48
Time frame: Participants will be followed up for 48 weeks after baseline.
The absolute change in the orientation dispersion index between baseline and week 48
Time frame: Participants will be followed up for 48 weeks after baseline.
The absolute change in the isotropic volume fraction between baseline and week 48
Time frame: Participants will be followed up for 48 weeks after baseline.
The absolute change in surface area between baseline and week 48.
Time frame: Participants will be followed up for 48 weeks after baseline.
The absolute change in thickness, between baseline and week 48.
Time frame: Participants will be followed up for 48 weeks after baseline.
The absolute change in volume, between baseline and week 48.
Time frame: Participants will be followed up for 48 weeks after baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 10g Astragalus, Routine treatment and 20g Astragalus in people with Alzheimer's Disease, run by Fujian Medical University Union Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaodong Pan (86218341, pxd77316@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Participants will be followed up for 48 weeks after baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.