Alzheimer DiseasePhase 2NCT05538507
Efficacy of Chinese Traditional Medicine "Smart Soup" in Cognition and Behavior Regulation in Alzheimer's Disease
A Phase 2 study testing smart soup, Donepezil and Memantine in people with Alzheimer Disease and Mild Cognitive Impairment, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
It is a prospective interventional randomized controlled single center trial. The goal of the trial is to evaluate the efficacy of smart soup on cognition, behavior, biomarkers and safety in Alzheimer's disease (aMCI and dementia). Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- smart soup, Donepezil and Memantine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to Jun 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NIA-AA 2011 AD probable Alzheimer's disease, mild to moderate, stable use donepezil 10mg/d for 3 months
- NIA-AA 2011 AD probable Alzheimer's disease, severe, stable use donepezil 10mg/d and memantine 20mg/d for 3 months
- NIA-AA 2011 MCI probable criteria
- stable care giver
- Traditional Chinese medicine diagnosis: pixu tanzhuo
Who cannot join
- Severe systemic disease (heart, liver ,kidney function failure)
- contradictions of MRI examination
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Chenhui Mao, Doctor, maochenhui@pumch.cn
Jing Gao, Doctor, gj107@163.com
About this study
It is a prospective interventional randomized controlled single center trial. The goal of the trial is to evaluate the efficacy of smart soup on cognition, behavior, biomarkers and safety in Alzheimer's disease (aMCI and dementia).
Read the detailed description
Alzheimer's disease (AD) is the most common cause of dementia and places a heavy burden on patients, families, society and healthcare. The drugs that have been marketed worldwide for the treatment of AD so far can only delay but not reverse the course of the disease, and the current drug development is all directed at a single target, while the onset of AD is the result of a combination of multiple factors, which is an important reason why so many drugs have faltered. The investigators need to find new multi-target intervention pathways from another perspective.
The advantage of Chinese medicine is multi-target and multi-factor regulation, which has advantages in treating complex diseases. The combination of ancient smart soup with donepezil was able to significantly improve the cognitive function in demented animals. Smart Soup is prepared from three herbs: Rhizoma Acori Tatarinowii, Poria cum Radix Pini, Radix Polygalae. These three herbs are each 15 grams and ground into a very fine powder. This approach reduced the formation of characteristic pathological changes at the pathological level, therefore, the combination of ancient Chinese medicine formulae with modern medical treatment may bring new hope to the treatment of demented patients.
The main design of this study are following: Patients over 40 years of age and eligible for NIA-AA 2011 probable AD and probable MCI were included in this study and were divided into 6 groups of 30 patients each. Group I AD patients were given donepezil 10 mg, memantine 20 mg and smart soup, group II AD patients were given donepezil 10 mg, memantine 20 mg and placebo; group III AD patients were given donepezil 10 mg and smart soup, group IV AD patients were given donepezil 10 mg and placebo; group V mild cognitive impairment (MCI) patients were given smart soup, and group VI MCI patients were given placebo.
Evaluations were set before enrollment, every three months till one year and the evaluators were single-blind. The scales involved in the evaluation of cognitive function and quality of life, sleep condition, and emotional behavior included ADAS-cog, MMSE, CDR, ADL, CMAI, NPI, and EQ-5D, which were evaluated five times. MRI, EEG, blood oxidative stress indicators, and biological markers were collected at the same time at enrollment and at the end of the study. Genotype collection was completed at enrollment. Safety was also evaluated with monthly testing of ECG, routine blood, liver and kidney function, urinary routine, and recording of side effects.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Being tested
- smart soup, Donepezil, Memantine, Placebo
- Keywords
- Alzheimer's disease, Traditional Chinese Medicine, Smart soup
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smart soupDrug
Also called traditional chinese medicine
Severe AD, mild or moderate AD and MCI will be given smart soup
DonepezilDrug
Also called donepezil pill
Severe AD and mild or moderate AD will be given donepezil
MemantineDrug
Also called Memantine Pill
Severe AD will be given memantine
PlaceboDrug
patients with MCI will be given placebo
| Study group | Role | What they receive |
|---|---|---|
| Group I severe AD | Active comparator | Patients over 40 years of age and eligible for NIA-AA 2011 probable severe AD will be given donepezil 10 mg, memantine 20 mg and smart soup Receives: Drug: smart soup; Drug: Donepezil; Drug: Memantine |
| Group II severe AD | Sham comparator | Patients over 40 years of age and eligible for NIA-AA 2011 probable severe AD will be given donepezil 10 mg, memantine 20 mg and placebo Receives: Drug: Donepezil; Drug: Memantine; Drug: Placebo |
| Group III Mild or moderate AD | Active comparator | Patients over 40 years of age and eligible for NIA-AA 2011 probable mild or moderate AD will be given donepezil 10 mg and smart soup Receives: Drug: smart soup; Drug: Donepezil |
| Group IV Mild or moderate AD | Sham comparator | Patients over 40 years of age and eligible for NIA-AA 2011 probable mild or moderate AD will be given donepezil 10 mg and placebo Receives: Drug: Donepezil; Drug: Placebo |
| Group V MCI | Active comparator | Patients over 40 years of age and eligible for NIA-AA 2011 probable MCI will be given smart soup Receives: Drug: smart soup |
| Group VI MCI | Sham comparator | Patients over 40 years of age and eligible for NIA-AA 2011 probable MCI will be given placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of cognitive screening
Using the neuropsychological scale, mini-mental state examination (MMSE,0-30), to assess every three months after trial entry
Measured: Through study completion, an average of 1 years
Changes of comprehensive cognitive assessment
Use the neuropsychological scales, Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-cog 0-75)， to assess every three months after trial entry
Measured: Through study completion, an average of 1 years
Changes in the degree of dementia
Use the neuropsychological scales, CDR(0-3), to assess every three months after trial entry
Measured: Through study completion, an average of 1 years
Changes in behavior
Use the Cohen-Mansfield Agitation Inventory (CMAI，29-203) to assess every three months after trial entry
Measured: Through study completion, an average of 1 years
Changes in Psychiatric symptoms
Use the Neuropsychiatric Index (NPI) to assess every three months after trial entry
Measured: Through study completion, an average of 1 years
Changes of daily living skills
Use Activity of Daily Living Scale（ADL，20-80）to assess every three months after trial entry
Measured: Through study completion, an average of 1 years
Changes in health status
Use EuroQoL 5-dimension (EQ-5D,0-100) to assess every three months after trial entry
Measured: Through study completion, an average of 1 years
Tau and Beta-amyloid biomarkers in CSF and plasma
Concentration ( pg/mL) of beta-amyloid, tau and phospho-tau in cerebrospinal fluid (CSF) and plasma of patients with dementia and controls
Measured: Through study completion, an average of 1 years
Magnetic resonance imaging and Electroencephalogram（EEG）
Evaluate the imaging and EEG changes of dementia patients. Specifically, EEG can be used to monitor the activity of brain waves in different parts of the cerebral cortex (e.g. power in alpha band, distribution and power of slow theta/delta waves etc.)
Measured: Through study completion, an average of 1 years
Oxidative stress markers in blood
Concentration of Dopamine in blood of patients with dementia and controls
Measured: Through study completion, an average of 1 years
Alterations of neurotransmitters in the blood
Concentration (ng/ml) of 5-hydroxy tryptamine (HT) in blood of patients with dementia and controls
Measured: Through study completion, an average of 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 Jun 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Model description
- Patients were divided into 6 groups according to the enrollment criteria, with 30 cases in each group. Group I AD patients were given donepezil 10 mg, memantine 20 mg and smart soup, group II AD patients were given donepezil 10 mg, memantine 20 mg and placebo; group III AD patients were given donepezil 10 mg and smart soup, group IV AD patients were given donepezil 10 mg and and placebo; group V MCI patients were given smart soup, and group VI MCI patients were given placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tongji University
- Responsible party
- Principal investigator, gaojing, Peking Union Medical College Hospital
- Investigators
- Jing Gao, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538507
- Sponsor's protocol ID
- Smart Soup
- Status last verified
- Sep 2022
- First submitted
- 12 Apr 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hou Y, Wang Y, Zhao J, Li X, Cui J, Ding J, Wang Y, Zeng X, Ling Y, Shen X, Chen S, Huang C, Pei G. Smart Soup, a traditional Chinese medicine formula, ameliorates amyloid pathology and related cognitive deficits. PLoS One. 2014 Nov 11;9(11):e111215. doi: 10.1371/journal.pone.0111215. eCollection 2014.
PubMed 25386946Wang Y, Wang Y, Sui Y, Yu H, Shen X, Chen S, Pei G, Zhao J, Ding J. The combination of aricept with a traditional Chinese medicine formula, smart soup, may be a novel way to treat Alzheimer's disease. J Alzheimers Dis. 2015;45(4):1185-95. doi: 10.3233/JAD-143183.
PubMed 25690664Ling Y, Li Z, Chen M, Sun Z, Fan M, Huang C. Analysis of multiple constituents in Cong-Ming-Tang, a Chinese herbal formula for the treatment of amnesia, by high-performance liquid chromatography with quadrupole time-of-flight mass spectrometry. Phytochem Anal. 2013 Nov-Dec;24(6):677-88. doi: 10.1002/pca.2454. Epub 2013 Jul 9.
PubMed 23839964McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.
PubMed 21514250
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Chinese Traditional Medicine "Smart Soup" in Cognition and Behavior Regulation in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05538507
- Acronym / sponsor ID
- Smart Soup
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Keywords
- Alzheimer's disease, Traditional Chinese Medicine, Smart soup
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Tongji University
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 14 Sep 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.
It is a prospective interventional randomized controlled single center trial. The goal of the trial is to evaluate the efficacy of smart soup on cognition, behavior, biomarkers and safety in Alzheimer's disease (aMCI and dementia).
Detailed description
Alzheimer's disease (AD) is the most common cause of dementia and places a heavy burden on patients, families, society and healthcare. The drugs that have been marketed worldwide for the treatment of AD so far can only delay but not reverse the course of the disease, and the current drug development is all directed at a single target, while the onset of AD is the result of a combination of multiple factors, which is an important reason why so many drugs have faltered. The investigators need to find new multi-target intervention pathways from another perspective.
The advantage of Chinese medicine is multi-target and multi-factor regulation, which has advantages in treating complex diseases. The combination of ancient smart soup with donepezil was able to significantly improve the cognitive function in demented animals. Smart Soup is prepared from three herbs: Rhizoma Acori Tatarinowii, Poria cum Radix Pini, Radix Polygalae. These three herbs are each 15 grams and ground into a very fine powder. This approach reduced the formation of characteristic pathological changes at the pathological level, therefore, the combination of ancient Chinese medicine formulae with modern medical treatment may bring new hope to the treatment of demented patients.
The main design of this study are following: Patients over 40 years of age and eligible for NIA-AA 2011 probable AD and probable MCI were included in this study and were divided into 6 groups of 30 patients each. Group I AD patients were given donepezil 10 mg, memantine 20 mg and smart soup, group II AD patients were given donepezil 10 mg, memantine 20 mg and placebo; group III AD patients were given donepezil 10 mg and smart soup, group IV AD patients were given donepezil 10 mg and placebo; group V mild cognitive impairment (MCI) patients were given smart soup, and group VI MCI patients were given placebo.
Evaluations were set before enrollment, every three months till one year and the evaluators were single-blind. The scales involved in the evaluation of cognitive function and quality of life, sleep condition, and emotional behavior included ADAS-cog, MMSE, CDR, ADL, CMAI, NPI, and EQ-5D, which were evaluated five times. MRI, EEG, blood oxidative stress indicators, and biological markers were collected at the same time at enrollment and at the end of the study. Genotype collection was completed at enrollment. Safety was also evaluated with monthly testing of ECG, routine blood, liver and kidney function, urinary routine, and recording of side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Patients were divided into 6 groups according to the enrollment criteria, with 30 cases in each group. Group I AD patients were given donepezil 10 mg, memantine 20 mg and smart soup, group II AD patients were given donepezil 10 mg, memantine 20 mg and placebo; group III AD patients were given donepezil 10 mg and smart soup, group IV AD patients were given donepezil 10 mg and and placebo; group V MCI patients were given smart soup, and group VI MCI patients were given placebo.
| Arm | Type | Receives |
|---|---|---|
| Group I severe AD | Active comparator | Drug: smart soup, Drug: Donepezil, Drug: MemantinePatients over 40 years of age and eligible for NIA-AA 2011 probable severe AD will be given donepezil 10 mg, memantine 20 mg and smart soup |
| Group II severe AD | Sham comparator | Drug: Donepezil, Drug: Memantine, Drug: PlaceboPatients over 40 years of age and eligible for NIA-AA 2011 probable severe AD will be given donepezil 10 mg, memantine 20 mg and placebo |
| Group III Mild or moderate AD | Active comparator | Drug: smart soup, Drug: DonepezilPatients over 40 years of age and eligible for NIA-AA 2011 probable mild or moderate AD will be given donepezil 10 mg and smart soup |
| Group IV Mild or moderate AD | Sham comparator | Drug: Donepezil, Drug: PlaceboPatients over 40 years of age and eligible for NIA-AA 2011 probable mild or moderate AD will be given donepezil 10 mg and placebo |
| Group V MCI | Active comparator | Drug: smart soupPatients over 40 years of age and eligible for NIA-AA 2011 probable MCI will be given smart soup |
| Group VI MCI | Sham comparator | Drug: PlaceboPatients over 40 years of age and eligible for NIA-AA 2011 probable MCI will be given placebo |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- NIA-AA 2011 AD probable Alzheimer's disease, mild to moderate, stable use donepezil 10mg/d for 3 months
- NIA-AA 2011 AD probable Alzheimer's disease, severe, stable use donepezil 10mg/d and memantine 20mg/d for 3 months
- NIA-AA 2011 MCI probable criteria
- stable care giver
- Traditional Chinese medicine diagnosis: pixu tanzhuo
Key exclusion criteria (2 listed)
- Severe systemic disease (heart, liver ,kidney function failure)
- contradictions of MRI examination
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 |
|---|---|---|
| smart soupAlso: traditional chinese medicineSevere AD, mild or moderate AD and MCI will be given smart soup | Drug | Group I severe AD, Group III Mild or moderate AD, Group V MCI |
| DonepezilAlso: donepezil pillSevere AD and mild or moderate AD will be given donepezil | Drug | Group I severe AD, Group II severe AD, Group III Mild or moderate AD, Group IV Mild or moderate AD |
| MemantineAlso: Memantine PillSevere AD will be given memantine | Drug | Group I severe AD, Group II severe AD |
| Placebopatients with MCI will be given placebo | Drug | Group II severe AD, Group IV Mild or moderate AD, Group VI MCI |
Primary outcome
Changes of cognitive screening
Time frame: Through study completion, an average of 1 years
Using the neuropsychological scale, mini-mental state examination (MMSE,0-30), to assess every three months after trial entry
Changes of comprehensive cognitive assessment
Time frame: Through study completion, an average of 1 years
Use the neuropsychological scales, Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-cog 0-75)， to assess every three months after trial entry
Changes in the degree of dementia
Time frame: Through study completion, an average of 1 years
Use the neuropsychological scales, CDR(0-3), to assess every three months after trial entry
Changes in behavior
Time frame: Through study completion, an average of 1 years
Use the Cohen-Mansfield Agitation Inventory (CMAI，29-203) to assess every three months after trial entry
Changes in Psychiatric symptoms
Time frame: Through study completion, an average of 1 years
Use the Neuropsychiatric Index (NPI) to assess every three months after trial entry
Changes of daily living skills
Time frame: Through study completion, an average of 1 years
Use Activity of Daily Living Scale（ADL，20-80）to assess every three months after trial entry
Changes in health status
Time frame: Through study completion, an average of 1 years
Use EuroQoL 5-dimension (EQ-5D,0-100) to assess every three months after trial entry
Tau and Beta-amyloid biomarkers in CSF and plasma
Time frame: Through study completion, an average of 1 years
Concentration ( pg/mL) of beta-amyloid, tau and phospho-tau in cerebrospinal fluid (CSF) and plasma of patients with dementia and controls
Magnetic resonance imaging and Electroencephalogram（EEG）
Time frame: Through study completion, an average of 1 years
Evaluate the imaging and EEG changes of dementia patients. Specifically, EEG can be used to monitor the activity of brain waves in different parts of the cerebral cortex (e.g. power in alpha band, distribution and power of slow theta/delta waves etc.)
Oxidative stress markers in blood
Time frame: Through study completion, an average of 1 years
Concentration of Dopamine in blood of patients with dementia and controls
Alterations of neurotransmitters in the blood
Time frame: Through study completion, an average of 1 years
Concentration (ng/ml) of 5-hydroxy tryptamine (HT) in blood of patients with dementia and controls
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Background: PubMed 25386946Hou Y, Wang Y, Zhao J, Li X, Cui J, Ding J, Wang Y, Zeng X, Ling Y, Shen X, Chen S, Huang C, Pei G. Smart Soup, a traditional Chinese medicine formula, ameliorates amyloid pathology and related cognitive deficits. PLoS One. 2014 Nov 11;9(11):e111215. doi: 10.1371/journal.pone.0111215. eCollection 2014.
- Background: PubMed 25690664Wang Y, Wang Y, Sui Y, Yu H, Shen X, Chen S, Pei G, Zhao J, Ding J. The combination of aricept with a traditional Chinese medicine formula, smart soup, may be a novel way to treat Alzheimer's disease. J Alzheimers Dis. 2015;45(4):1185-95. doi: 10.3233/JAD-143183.
- Background: PubMed 23839964Ling Y, Li Z, Chen M, Sun Z, Fan M, Huang C. Analysis of multiple constituents in Cong-Ming-Tang, a Chinese herbal formula for the treatment of amnesia, by high-performance liquid chromatography with quadrupole time-of-flight mass spectrometry. Phytochem Anal. 2013 Nov-Dec;24(6):677-88. doi: 10.1002/pca.2454. Epub 2013 Jul 9.
- Background: PubMed 21514250McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.
- 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.
Jing Gao, MD principal investigator
Peking Union Medical College Hospital
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 smart soup, Donepezil and Memantine in people with Alzheimer Disease and Mild Cognitive Impairment, run by Peking Union Medical College 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 5 inclusion and 2 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 14 Sep 2022. 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. Some participants in this study may receive a placebo. 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 Chenhui Mao, MD (+86-010-69151389, maochenhui@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of cognitive screening (time frame: Through study completion, an average of 1 years). The study lists 11 primary outcomes in all. 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 NCT05538507, which also lists 4 linked publications.
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 14 Sep 2022.