Alzheimer DiseasePhase 2NCT06694597
Efficacy, Safety of Astragalus Membranaceus in Mild-to-Moderate Alzheimer's Disease
A Phase 2 study testing Astragalus Membranaceus Root in people with Alzheimer 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 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Astragalus Membranaceus Root
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 31 Mar 2024
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participate voluntarily and sign an informed consent form
- Age 50-85 years old;
- Memory loss for at least 6 months with a tendency of progressive deterioration;
- Mild or moderate patients, i.e. MMSE total score:14< MMSE total score<24, 0.5≤CDR-GS≤2;
- The highest likelihood of AD (medial temporal lobe atrophy visual rating scale grade 2 or higher on coronal imaging) as demonstrated by cranial MRI scanning and oblique coronal hippocampal scanning review at the time of screening;
- Hachinski Ischemia Scale (HIS) score < 4;
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- A diagnosis of dementia according to the DSM-V and a diagnosis of "probable AD" according to the NIA-AA criteria;
- No significant positive signs on neurological examination;
- The subject has the ability to read, write, and communicate, the subject has a stable and reliable caregiver or at least has frequent contact with the caregiver (at least 2 hours per day, 4 days per week), the caregiver will help the patient to participate in the study, the caregiver must accompany the subject to the study visit, and there must be sufficient interaction with the subject to provide valuable information for the rating of the scales. information for each scale score;
- The underlying treatment for AD prior to enrolment remains unchanged, but needs to have been on long-term stable use for more than 4 weeks prior to randomisation to the subgroups, and the dose remains stable during the study period. Such drugs include:cholinesterase inhibitors and memantine;
- The TCM diagnosis was spleen and kidney deficiency. -
Who cannot join
- Non-AD-induced memory and cognitive impairment, such as a diagnosis of other types of dementia, including, but not limited to, Mixed Disease Dementia, Vascular Dementia, Parkinson's Disease Dementia, Lewy Body Dementia, Huntington's Chorea-related Dementia, Normal Pressure Hydrocephalus, Brain Tumour, Progressive Supranuclear Palsy, Frontotemporal Lobar Dementia, etc.; Endocrine system pathology (e.g., Thyroid Disease, Parathyroid Disease) as well as Folic Acid, Vitamin B12 deficiency or any other causes of dementia; the presence of impaired consciousness, etc;
- A history of seizures; psychosis, including but not limited to schizophrenia, schizoaffective disorder, bipolar disorder, or delirium; and
- Hamilton Depression Scale (HAMD) score >17;
- Significant focal lesions on MRI with one of the following: a. >2 infarct foci >2cm in diameter; b. Infarct foci in key areas such as thalamus, hippocampus, internal olfactory cortex, parafrontal olfactory cortex, angular gyrus, cortex, and other subcortical grey matter nuclei; and c. Cerebral white matter damage with a Fazekas Scale score ≥3;
- Patients who have taken other herbal preparations within the past 1 month;
- Astragalus allergy or contraindication;
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- Presence of abnormal laboratory parameters: impaired renal function (blood Cr > 1.5xULN) or creatinine clearance (C cr) < 50mL/min or abnormal liver function (ALT or AST > 2xULN);
- Patients who refused or had contraindications to MRI or EEG (pacemakers, coronary and peripheral arterial stents, metallic implants, claustrophobia, or severe visual or hearing impairments); refused to have blood drawn;
- Hachinski Ischaemia Scale score ≥ 4;
- Pregnant or breastfeeding patients; and
- Other unmanageable clinical problems (e.g. neoplasms, HIV infection, syphilis spirochete infection, hepatitis C virus infection, active hepatitis B or other severe chronic infectious diseases, severe neurological, cardiovascular, respiratory and other systemic diseases);
- Patients who have participated in other clinical studies within the past 3 months;
- Those who, in the opinion of the investigator, need to be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Astragalus Membranaceus on the Improvement of Cognitive and Non-cognitive Symptoms in Mild-to-Moderate Alzheimer's Disease
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 Disease
- Being tested
- Astragalus Membranaceus Root
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astragalus Membranaceus RootDrug
Astragalus tablets 15g, 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 |
|---|---|---|
| Astragalus membranaceus | Experimental | Not described Receives: Drug: Astragalus Membranaceus Root |
| Routine treatment | No intervention | Not described |
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 Clinical Dementia Rating
Clinical Dementia Rating scale scores range from 0 to 18, with higher scores indicating worse.
Measured: Participants were followed up for 24 weeks after baseline.
Secondary outcomes (26)
The absolute scores change in the Rey-Osterrieth Complex Figure Test [ROCF] recall score between baseline and week 24
The ROCF scale scores range from 0 to 36, with higher scores indicating better.
Measured: Participants were followed up for 24 weeks after baseline.
The absolute scores change in the Rey-Osterrieth Complex Figure Test-copy score between baseline and week 24
The ROCF copy scale scores range from 0 to 36, with higher scores indicating better.
Measured: Participants were followed up for 24 weeks after baseline.
The absolute scores change in the Trail Making Test-A score between baseline and week 24
The Trail Making Test-A scores range from 0 to 25, with higher scores indicating better.
Measured: Participants were followed up for 24 weeks after baseline.
The absolute scores change in the Digit Span Forward score between baseline and week 24
TheDigit Span Forward score scores range from 0 to 10, with higher scores indicating better.
Measured: Participants were followed up for 24 weeks after baseline.
The absolute scores change in the Trail Making Test-B score between baseline and week 24
The Trail Making Test-B scores range from 0 to 25, with higher scores indicating better.
Measured: Participants were followed up for 24 weeks after baseline.
The absolute scores change in the Digit Span Backward score between baseline and week 24
The Digit Span Forward score scores range from 0 to 9, with higher scores indicating better.
Measured: Participants were followed up for 24 weeks after baseline.
The absolute scores change in the Verbal Fluency Test score between baseline and week 24
The Verbal Fluency Test score scores range from 0 to 14, with higher scores indicating better.
Measured: Participants were followed up for 24 weeks after baseline.
The absolute scores change in the Hamilton Anxiety Scale score between baseline and week 24
The Hamilton Anxiety Scale score scores range from 0 to 56, with higher scores indicating worse.
Measured: Participants were followed up for 24 weeks after baseline.
The absolute scores change in the Hamilton Depression Scale score between baseline and week 24
The Hamilton Anxiety Scale score scores range from 0 to 96, with higher scores indicating worse
Measured: Participants were followed up for 24 weeks after baseline.
The absolute change in the blood pressure between baseline and week 24
To observe the changes of orthostatic blood pressure in patients
Measured: Participants were followed up for 24 weeks after baseline.
The absolute change in the level of plasma β-amyloid40 (ng/ml) between baseline and week 24
Amyloid is one of the main biomarkers of dementia
Measured: Participants were followed up for 24 weeks after baseline.
The absolute change in the level of plasma β-amyloid42 (ng/ml) between baseline and week 24
Amyloid is one of the main biomarkers of dementia
Measured: Participants were followed up for 24 weeks after baseline.
The absolute change in the level of plasma glial fibrillary acidic protein (ng/ml) between baseline and week 24
Glial fibrillary acidic protein is one of the main biomarkers of dementia
Measured: Participants were followed up for 24 weeks after baseline.
The absolute change in the level of plasma neurofilament light chain (ng/ml) between baseline and week 24
Neurofilament light chain is one of the main biomarkers of dementia
Measured: Participants were followed up for 24 weeks after baseline.
The absolute change in the level of plasma hyper-phosphorylated tau-181 (ng/ml) between baseline and week 24
Neurofilament light chain is one of the main biomarkers of dementia
Measured: Participants were followed up for 24 weeks after baseline.
The absolute change in the neurite density index between baseline and week 24
Neurite density index, range from 0-1, is the main indicator of neurite-oriented diffusion and density imaging (NODDI),with higher scores indicating better
Measured: Participants were followed up for 24 weeks after baseline.
The absolute change in the orientation dispersion index between baseline and week 24
Orientation dispersion indexrange from 0-1, is the main indicator of neurite-oriented diffusion and density imaging (NODDI) ,with higher scores indicating better.
Measured: Participants were followed up for 24 weeks after baseline.
The absolute change in the isotropic volume fraction between baseline and week 24
Isotropic volume fraction, range from 0-1, is the main indicator of neurite-oriented diffusion and density imaging (NODDI), with higher scores indicating worse .
Measured: Participants were followed up for 24 weeks after baseline.
The absolute change in thickness, between baseline and week 24.
Cortical thickness is the main indicator of grey matter.Cortical thickness was obtained by analyzing structural MRI using the freesurfer.
Measured: Participants were followed up for 24 weeks after baseline.
The absolute change in volume, between baseline and week 24
Volume, is the main indicator of brain structure.Volume was obtained by analyzing structural MRI using thevoxel-based morphometry
Measured: Participants were followed up for 24 weeks after baseline.
The absolute change in delta, between baseline and week 24
Delta, is the main indicator of the cerebral cortex activity
Measured: Participants were followed up for 24 weeks after baseline.
The absolute change in theta, between baseline and week 24
Theta, is the main indicator of the cerebral cortex activity（range from 4-7.5Hz）
Measured: Participants were followed up for 24 weeks after baseline.
The absolute change in alpha, between baseline and week 24
Alpha, is the main indicator of the cerebral cortex activity（range from 7.5-14Hz）
Measured: Participants were followed up for 24 weeks after baseline.
The absolute change in beta1, between baseline and week 24
Beta1, is the main indicator of the cerebral cortex activity（range from 14-20Hz）
Measured: Participants were followed up for 24 weeks after baseline.
The absolute change in beta2, between baseline and week 24
Beta2, is the main indicator of the cerebral cortex activity（range from 20-30Hz）
Measured: Participants were followed up for 24 weeks after baseline.
The absolute change in gamma, between baseline and week 24
Gamma, is the main indicator of the cerebral cortex activity（range from 30-50Hz）
Measured: Participants were followed up for 24 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 posted19 Nov 2024
- Study start1 May 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer 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
- 76 participants (actual)
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
- NCT06694597
- Sponsor's protocol ID
- Huangqi_AD
- Status last verified
- Jul 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Astragalus Membranaceus on the Improvement of Cognitive and Non-cognitive Symptoms in Mild-to-Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06694597
- Acronym / sponsor ID
- Huangqi_AD
- Conditions
- Alzheimer Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 19 Nov 2024 (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
- 2
| Arm | Type | Receives |
|---|---|---|
| Astragalus membranaceus | Experimental | Drug: Astragalus Membranaceus Root |
| Routine treatment | No intervention | – |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participate voluntarily and sign an informed consent form
- Age 50-85 years old;
- Memory loss for at least 6 months with a tendency of progressive deterioration;
- Mild or moderate patients, i.e. MMSE total score:14< MMSE total score<24, 0.5≤CDR-GS≤2;
- The highest likelihood of AD (medial temporal lobe atrophy visual rating scale grade 2 or higher on coronal imaging) as demonstrated by cranial MRI scanning and oblique coronal hippocampal scanning review at the time of screening;
Key exclusion criteria (13 listed)
- Non-AD-induced memory and cognitive impairment, such as a diagnosis of other types of dementia, including, but not limited to, Mixed Disease Dementia, Vascular Dementia, Parkinson's Disease Dementia, Lewy Body Dementia, Huntington's Chorea-related Dementia, Normal Pressure Hydrocephalus, Brain Tumour, Progressive Supranuclear Palsy, Frontotemporal Lobar Dementia, etc.; Endocrine system pathology (e.g., Thyroid Disease, Parathyroid Disease) as well as Folic Acid, Vitamin B12 deficiency or any other causes of dementia; the presence of impaired consciousness, etc;
- A history of seizures; psychosis, including but not limited to schizophrenia, schizoaffective disorder, bipolar disorder, or delirium; and
- Hamilton Depression Scale (HAMD) score >17;
- Significant focal lesions on MRI with one of the following: a. >2 infarct foci >2cm in diameter; b. Infarct foci in key areas such as thalamus, hippocampus, internal olfactory cortex, parafrontal olfactory cortex, angular gyrus, cortex, and other subcortical grey matter nuclei; and c. Cerebral white matter damage with a Fazekas Scale score ≥3;
- Patients who have taken other herbal preparations within the past 1 month;
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 |
|---|---|---|
| Astragalus Membranaceus RootAstragalus tablets 15g, warm water to drink, once a day, take for 1 year, during which routine treatment should also be carried out. | Drug | Astragalus membranaceus |
Primary outcome
The primary efficacy outcome measure will be the absolute change in the Clinical Dementia Rating
Time frame: Participants were followed up for 24 weeks after baseline.
Clinical Dementia Rating scale scores range from 0 to 18, with higher scores indicating worse.
26 secondary outcomes
The absolute scores change in the Rey-Osterrieth Complex Figure Test [ROCF] recall score between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute scores change in the Rey-Osterrieth Complex Figure Test-copy score between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute scores change in the Trail Making Test-A score between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute scores change in the Digit Span Forward score between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute scores change in the Trail Making Test-B score between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute scores change in the Digit Span Backward score between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute scores change in the Verbal Fluency Test score between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute scores change in the Hamilton Anxiety Scale score between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute scores change in the Hamilton Depression Scale score between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute change in the blood pressure between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute change in the level of plasma β-amyloid40 (ng/ml) between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute change in the level of plasma β-amyloid42 (ng/ml) between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute change in the level of plasma glial fibrillary acidic protein (ng/ml) between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute change in the level of plasma neurofilament light chain (ng/ml) between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute change in the level of plasma hyper-phosphorylated tau-181 (ng/ml) between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute change in the neurite density index between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute change in the orientation dispersion index between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute change in the isotropic volume fraction between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute change in thickness, between baseline and week 24.
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute change in volume, between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute change in delta, between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute change in theta, between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute change in alpha, between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute change in beta1, between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute change in beta2, between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
The absolute change in gamma, between baseline and week 24
Time frame: Participants were followed up for 24 weeks after baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Astragalus Membranaceus Root in people with Alzheimer 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 11 inclusion and 13 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: finished, as of the sponsor's last update on 19 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 Clinical Dementia Rating (time frame: Participants were followed up for 24 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 19 Nov 2024.