Orthostatic HypotensionPhase 2NCT05647473
Efficacy, Safety and Response Predictors of Adjuvant Astragalus for Cognition in Orthostatic Hypotension
A Phase 2 study testing Routine treatment, add-on low dose Astragalus and add-on high dose Astragalus in people with Orthostatic Hypotension and Alzheimer Disease, run by Fujian Medical University Union Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Orthostatic Hypotension, Alzheimer Disease
- What is being tested?
- Routine treatment, add-on low dose Astragalus and add-on high dose Astragalus
- Type of treatment
- 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
- 20 Feb 2024to 30 May 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 85 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
- A decrease in systolic blood pressure of 20 mm Hg or a decrease in diastolic blood pressure 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: 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
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- 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 and diamantine.
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.
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- 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 Adjuvant Astragalus for Cognition in Alzheimer Disease With Orthostatic Hypotension: an add-on, Assessor-blind, Pragmatic Randomized Controlled Trial
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.
- Conditions
- Orthostatic Hypotension, Alzheimer Disease
- Being tested
- Routine treatment, add-on low dose Astragalus, add-on high dose Astragalus
- Medical subject headings
- Hypotension, Orthostatic, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine treatmentBehavioural
Participants will be educated on ways to avoid induced hypotensive states, such as avoiding prolonged standing, standing after exercise, being nervous, eating several carbohydrate-rich foods, drinking alcohol, and being in a warm environment (such as a sauna). Participants will be encouraged in a comfortable home environment, such as a sit-down bath. If there are no contraindications, they are advised to increase their salt intake to approximately 10 grams per day and adjust their fluid intake to 2-3 liters per day. They will also be encouraged to perform lower-body strength training and moderate, non-strenuous activities. Seriously ill patients will be proposed to raise the head of their bed during sleep, wear tight clothing, eat small meals, and reduce alcohol intake.Concomitant treatment with cholinesterase inhibitors, memantine, or both was allowed.
add-on low dose AstragalusDrug
Participants received an additional 10g of astragalus per day.
add-on high dose AstragalusDrug
Participants received an additional 20g of astragalus per day.
| Study group | Role | What they receive |
|---|---|---|
| add-on low dose Astragalus | Experimental | Not described Receives: Behavioral: Routine treatment; Drug: add-on low dose Astragalus |
| Routine treatment | Experimental | Not described Receives: Behavioral: Routine treatment |
| add-on high dose Astragalus | Experimental | Not described Receives: Behavioral: Routine treatment; Drug: add-on high dose 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 (24)
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.
TheDigit 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 theheart rate variability between baseline and week 48.
The KARDi2/4-B autonomic nervous function mapping ECG system (Nanjing Left and Right Brain Biomedical Company, NeuroMed, China) will record and analyze millivolt-level signals of ECG oscillations, complete the frequency domain and time domain index detection of heart rate variability in 3 min, and generate an autonomic nervous function status step map.
Measured: Participants will be followed up for 48 weeks after baseline.
The absolute change in the Montreal Cognitive Assessment(MOCA) score between baseline and week 48.
The Alzheimer's Disease Assessment Scale-Cognitive Subscale, Chinese version scale scores range from 0 to 30, with higher scores indicating better.
Measured: Participants will be followed up for48 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 posted12 Dec 2022
- Study start20 Feb 2024 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthostatic HypotensionStudies 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
- Double blind
- Who is masked
- Care provider, 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
- NCT05647473
- Sponsor's protocol ID
- AM-AD
- Status last verified
- Jan 2024
- First submitted
- 4 Dec 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng Y, Lin L, Huang P, Zhang J, Pan X. Efficacy, safety, and response predictors of Astragalus in patients with mild to moderate Alzheimer's disease: A study protocol of an assessor-blind, statistician-blind open-label randomized controlled trial. Contemp Clin Trials Commun. 2024 Jul 28;41:101339. doi: 10.1016/j.conctc.2024.101339. eCollection 2024 Oct.
PubMed 39176240
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Response Predictors of Adjuvant Astragalus for Cognition in Alzheimer Disease With Orthostatic Hypotension: an add-on, Assessor-blind, Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05647473
- Acronym / sponsor ID
- AM-AD
- Conditions
- Orthostatic Hypotension, Alzheimer 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
- 20 Feb 2024 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 12 Dec 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| add-on low dose Astragalus | Experimental | Behavioral: Routine treatment, Drug: add-on low dose Astragalus |
| Routine treatment | Experimental | Behavioral: Routine treatment |
| add-on high dose Astragalus | Experimental | Behavioral: Routine treatment, Drug: add-on high dose Astragalus |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female aged ≥50 years and ≤85 years
- A decrease in systolic blood pressure of 20 mm Hg or a decrease in diastolic blood pressure 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: 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
Key exclusion criteria (9 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.
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 |
|---|---|---|
| Routine treatmentParticipants will be educated on ways to avoid induced hypotensive states, such as avoiding prolonged standing, standing after exercise, being nervous, eating several carbohydrate-rich foods, drinking alcohol, and being in a warm environment (such as a sauna). Participants will be encouraged in a comfortable home environment, such as a sit-down bath. If there are no contraindications, they are advised to increase their salt intake to approximately 10 grams per day and adjust their fluid intake to 2-3 liters per day. They will also be encouraged to perform lower-body strength training and moderate, non-strenuous activities. Seriously ill patients will be proposed to raise the head of their bed during sleep, wear tight clothing, eat small meals, and reduce alcohol intake.Concomitant treatment with cholinesterase inhibitors, memantine, or both was allowed. | Behavioural | Routine treatment, add-on high dose Astragalus, add-on low dose Astragalus |
| add-on low dose AstragalusParticipants received an additional 10g of astragalus per day. | Drug | add-on low dose Astragalus |
| add-on high dose AstragalusParticipants received an additional 20g of astragalus per day. | Drug | add-on high dose Astragalus |
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.
24 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 theheart rate variability between baseline and week 48.
Time frame: Participants will be followed up for 48 weeks after baseline.
The absolute change in the Montreal Cognitive Assessment(MOCA) score between baseline and week 48.
Time frame: Participants will be followed up for48 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 5 Jan 2024.
- Derived from this study: PubMed 39176240Cheng Y, Lin L, Huang P, Zhang J, Pan X. Efficacy, safety, and response predictors of Astragalus in patients with mild to moderate Alzheimer's disease: A study protocol of an assessor-blind, statistician-blind open-label randomized controlled trial. Contemp Clin Trials Commun. 2024 Jul 28;41:101339. doi: 10.1016/j.conctc.2024.101339. eCollection 2024 Oct.
- 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 Routine treatment, add-on low dose Astragalus and add-on high dose Astragalus in people with Orthostatic Hypotension and 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 9 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 5 Jan 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?
On the ClinicalTrials.gov record for NCT05647473, which also lists 1 linked publication.
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 5 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.