Cerebral Small Vessel DiseasesPhase 2MIRACLENCT05982470
Effect of Menopause Hormone Therapy In Postmenopausal Women With CSVD And MCI
A Phase 2 study testing Estradiol Gel and Progesterone Soft Capsule in people with Cerebral Small Vessel Diseases and Postmenopausal Symptoms, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The objective of this clinical trial is to explore the efficacy of menopausal hormone therapy in early menopausal women with CSVD and MCI. The main questions it aims to answer are: The efficacy of menopausal hormone mainly estrogen therapy for early menopausal women with CSVD and MCI The role of MHT in delaying the… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Cerebral Small Vessel Diseases, Postmenopausal Symptoms, Mild Cognitive Impairment
- What is being tested?
- Estradiol Gel and Progesterone Soft Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 328 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2023to 1 Oct 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 40 ≤ age < 60 years
- Female;
- 1 year ≤ Natural menopause≤ 6 years;
- FSH ≥ 35 miu/ml and E2 ≤ 25 pg/ml;
- Head MRI shows CSVD-related image changes, meet one of the following:
- Parventricular or deep brain white matter hyperintense, Fazekas ≥ 2；
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- Parventricular or deep brain white matter hyperintense, Fazekas = 1, with more than 2 vascular risk factors (hypertension, hyperlipidemia, type 2 diabetes, obesity, current smoking);
- Parventricular or deep brain white matter hyperintense, Fazekas = 1, with more than 1 vascular-derived lacunae;
- Recent small subcortical infarction within the last 3 months
- Mild cognitive dysfunction (18 ≤ MoCA <26);
- Independent in daily life (mRS ≤ 1）
- Sign informed consent.
- Note:
- Natural menopause: The self-reported last menstrual date of the subject
- CSVD related image changes: evaluated according to the STRIVE2 standard issued in 2023;
- Fazekas score: The total score is 6 , which is the sum of Fazekas scores for subcortical and periventricular white matter lesions;
- Recent subcortical small infarcts: lesions with a diameter of<20mm in the subcortical, basal ganglia, or brainstem regions that exhibit high signal intensity (ADC diffusion limitation) on DWI imaging, with or without corresponding clinical symptoms; With new clinical symptoms, FLAIR hyperintense lesions (<20mm in diameter) in subcortical, basal ganglia or corresponding parts of pons can be seen in FLAIR sequence of head MRI.
- MoCA: Montreal Cognitive Assessment; If the subject's education period ≤ 12 years, then increase by 1 point, with a maximum score of 30 points;
- mRS: Modified Rankin Scale
Who cannot join
- Inheritable CSVD, such as CADASIL, CARASIL, etc.
- Confirmed neurodegenerative diseases, such as AD and PD;
- Clear non-vascular white matter lesions, such as multiple sclerosis, adult brain white matter dysplasia, metabolic encephalopathy, etc.
- History of intracranial hemorrhagic disease within the recent 6 months, including cerebral parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural / extradural hematoma, etc., as well as untreated aneurysms (diameter> 3mm) and cerebrovascular malformations.
- Cardiovascular and cerebrovascular events within the past 6 months, such as myocardial infarction, unstable angina pectoris, cerebral infarction, etc.
- Previously received or initiated menopausal hormone therapy.
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- Previous Hysterectomy
- Vaginal bleeding of unknown origin
- Intra- and extra- cranial Atherosclerosis large artery stenosis (50-99%) or occlusion.
- Active venous or arterial thromboembolic diseases, such as Deep vein thrombosis, Pulmonary embolism, myocardial infarction, angina pectoris or congestive heart failure, in the last 6 months.
- Used drugs and Phytoestrogen supplements that affect estrogen levels in the past 3 months, such as soybean concentrate or extract, Kuntai capsule, Dingkundan, Lifumin, etc.
- Endometrial hyperplasia, vaginal ultrasound indicates endometrial ≥ 5mm (note: those confirmed as benign lesions by pathology can be included).
- Severe liver and kidney dysfunction: severe liver dysfunction refers to Alanine transaminase>3 times the upper limit of normal value or cereal grass Transaminase>3 times the upper limit of normal value; Severe renal insufficiency refers to blood creatinine>3.0 mg/dl (265.2 μmol/L) or glomerular filtration rate<30 ml/min/1.73m^2;
- Hypertension is still difficult to control after standardized treatment (blood pressure>160/100mmHg); Type 2 diabetes is still difficult to control after standard treatment (Glycated hemoglobin ≥ 8%).
- Known or suspected to have sex hormone dependent malignant tumors, such as breast cancer, endometrial cancer, cervical adenocarcinoma, ovarian cancer, and meningioma.
- Suffering from severe organic diseases with an expected survival time of<5 years.
- Other situations that are not suitable for menopausal hormone treatment, such as porphyria, otosclerosis, etc.
- Mental disorders diagnosed according to DSM-5 diagnostic criteria, or previous mental system diseases that cannot be fully communicated.
- Allergies to the active ingredients or any of the excipients of the research drug.
- Contraindications to MRI examination, such as Claustrophobia, metal implants in the body, etc.
- Unable to cooperate in completing follow-up due to geographical or other reasons.
- Situations deemed unsuitable by other researchers to participate in the study.
- Participating in other interventional clinical trials. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Menopause Hormone Therapy In Postmenopausal Women With CeRebral Small Vessel DiseAse And Mild Cognitive DecLinE
The objective of this clinical trial is to explore the efficacy of menopausal hormone therapy in early menopausal women with CSVD and MCI.
The main questions it aims to answer are:
- The efficacy of menopausal hormone mainly estrogen therapy for early menopausal women with CSVD and MCI
- The role of MHT in delaying the progression of cognitive function, CSVD imaging features, and other clinical symptoms and the potential pathophysiological mechanisms.
Participants will be divided randomly into two groups taking MHT drugs and placebo respectively and followed up for 12 months to collect relevant clinical data.
Read the detailed description
Cerebral small vessel disease (CSVD) is a common chronic whole brain syndrome in middle-aged and elderly people, mainly involving small-arteries, arterioles, capillaries, venules and small-veins in the brain. CSVD mainly relies on typical imaging features for diagnosis. Aging is the most common risk factor for CSVD. With the acceleration of China's aging process, the Disease burden of CSVD is increasing.
Menopause refers to the permanent cessation of menstruation caused by ovarian failure. During menopause, drastic changes in hormones can have a series of effects on women.Research shows that menopause is an independent risk factor for WMH. Meanwhile, menopause is significantly associated with cognitive impairment, especially with decreased learning, memory, and attention. Menopause can also cause changes in cerebral hemodynamics, damage to the integrity of the Blood-brain barrier and atrophy of cortical structures.
Estrogen not only plays a crucial role in maintaining vascular function, but also has significant neuro-protective effects. Estrogen-based menopausal hormone therapy (MHT) is essentially a treatment measure taken to compensate for ovarian failure caused by aging.
However, it is still unclear whether MHT can effectively alleviate CSVD symptoms and delay CSVD progression. The MHT treatment plan may also be an important reason for the inconsistent conclusions on the impact of MHT on cognitive function in various clinical studies. In previous clinical studies, the MHT regimen was oral estrogen (with or without Progestogen).
Based on the above research background, MHT, especially the MHT regimen using transdermal estrogen, may be an effective treatment method to improve and alleviate the rapid progression of CSVD in perimenopausal women(without contraindications). So far, there have been no RCT studies evaluating the effectiveness and safety of MHT in CSVD patients internationally. Therefore, more research is needed to provide stronger evidence and provide new directions and basis for the treatment of CSVD.
Participates who met the inclusion criteria were randomly divided into two groups. Participants were treated with MHT/placebo followed up for 12 months, and collected and analyzed relevant clinical data to evaluate the efficacy.
- Conditions
- Cerebral Small Vessel Diseases, Postmenopausal Symptoms, Mild Cognitive Impairment, White Matter Hyperintensity
- Being tested
- Estradiol Gel, Estradiol Placebo Gel, Progesterone Soft Capsule, Progesterone Placebo Soft Capsule
- Keywords
- cerebral small vessel diseases, Menopausal Hormone Therapy, Postmenopausal Symptoms, Mild Cognitive Impairment, White Matter Hyperintensity
- Medical subject headings
- Cerebral Small Vessel Diseases, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol GelDrug
Estradiol gel 2.5 g (containing 17β estradiol 1.5mg) once daily (percutaneous application) for 12 months
Estradiol Placebo GelDrug
Estradiol placebo gel 2.5 g (containing 17β estradiol 1.5mg) once daily (percutaneous application) for 12 months
Progesterone Soft CapsuleDrug
Progesterone soft capsules 100mg once daily (oral) for 12 months
Progesterone Placebo Soft CapsuleDrug
Progesterone placebo soft capsules 100mg once daily (oral) for 12 months
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Estradiol gel 2.5 g (containing 17β estradiol 1.5mg) once daily (percutaneous application)* in combination with progesterone soft capsules 100mg once daily (oral) for 12 months
Note :
* Usage and dosage of estradiol gel: A dose of ruler is applied to the skin of the arm, shoulder, head and neck, abdomen, thigh or face every morning or evening. It is dry about two minutes after application. It is non-irritating, colorless, or milky white and tasteless, and is best used after bathing. Receives: Drug: Estradiol Gel; Drug: Progesterone Soft Capsule |
| control group | Placebo comparator | Estradiol placebo gel 2.5g (containing 17β estradiol 0mg) once daily (percutaneous application) *in combination with progesterone placebo soft capsules(containing progesterone 0mg) 100mg once daily (oral) for 12 months
Note :
* Usage and dosage of estradiol placebo gel : A dose of ruler is applied to the skin of the arm, shoulder, head and neck, abdomen, thigh or face every morning or evening. It is dry about two minutes after application. It is non-irritating, colorless, or milky white and tasteless, and is best used after bathing. Receives: Drug: Estradiol Placebo Gel; Drug: Progesterone Placebo Soft Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
the changes in the Montreal Cognitive Assessment (MoCA; range, 0-30; with lower scores indicating more severe cognitive impairment) scores 1 year after randomization compared to baseline
the changes of the Montreal Cognitive Assessment (MoCA; range, 0-30; with lower scores indicating more severe cognitive impairment) scores
Measured: 1 year after randomization
Secondary outcomes (8)
the changes in each cognitive domain estimated bythe Montreal Cognitive Assessment (MoCA; range, 0-30; with lower scores indicating more severe cognitive impairment) sub-items 1 year after randomization compared to baseline
the changes in each cognitive domain estimated by the Montreal Cognitive Assessment (MoCA; range, 0-30; with lower scores indicating more severe cognitive impairment) sub-items
Measured: 1 year after randomization
the changes of modified Kupperman scores (0-63; with higher scores indicating more severe symptoms) 1 year after randomization compared to baseline
the changes of modified Kupperman scores (0-63; with higher scores indicating more severe symptoms)
Measured: 1 year after randomization
the changes of Pittsburgh sleep quality index(PSQI; with higher scores indicating more severe sleep quality) 1 year after randomization compared to baseline
the changes of Pittsburgh sleep quality index(PSQI; with higher scores indicating more severe sleep quality)
Measured: 1 year after randomization
the changes of Hamilton Depression Scale(HAMD; ranges, 0-54; with higher scores indicating more severe depression) 1 year after randomization compared to baseline
the changes of Hamilton Depression Scale(HAMD; ranges, 0-54; with higher scores indicating more severe depression)
Measured: 1 year after randomization
the changes of Hamilton Anxiety Scale(HAMA; ranges, 0-56; with higher scores indicating more severe anxiety) 1 year after randomization compared to baseline
the changes of Hamilton Anxiety Scale(HAMA; ranges, 0-56; with higher scores indicating more severe anxiety)
Measured: 1 year after randomization
the changes of the volume of white matter hyperintensity 1 year after randomization compared to baseline
the changes of the volume of white matter hyperintensity
Measured: 1 year after randomization
Serum levels of estradiol 1 year after randomization compared to baseline
Serum levels of estradiol
Measured: 1 year after randomization
Serum levels of follicle stimulating hormone 1 year after randomization compared to baseline
Serum levels of follicle stimulating hormone
Measured: 1 year after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start18 Aug 2023 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Small Vessel DiseasesStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yilong Wang, Beijing Tiantan Hospital
- Investigators
- yilong wang, MD,PhD, Principal investigator, Beiiing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982470
- Sponsor's protocol ID
- KY2023-117
- Acronym
- MIRACLE
- Status last verified
- Aug 2023
- First submitted
- 18 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Menopause Hormone Therapy In Postmenopausal Women With CeRebral Small Vessel DiseAse And Mild Cognitive DecLinE
- ClinicalTrials.gov ID
- NCT05982470
- Acronym / sponsor ID
- MIRACLE / KY2023-117
- Conditions
- Cerebral Small Vessel Diseases, Postmenopausal Symptoms, Mild Cognitive Impairment, White Matter Hyperintensity
- Keywords
- cerebral small vessel diseases, Menopausal Hormone Therapy, Postmenopausal Symptoms, Mild Cognitive Impairment, White Matter Hyperintensity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 18 Aug 2023 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 8 Aug 2023 (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.
The objective of this clinical trial is to explore the efficacy of menopausal hormone therapy in early menopausal women with CSVD and MCI.
The main questions it aims to answer are:
- The efficacy of menopausal hormone mainly estrogen therapy for early menopausal women with CSVD and MCI
- The role of MHT in delaying the progression of cognitive function, CSVD imaging features, and other clinical symptoms and the potential pathophysiological mechanisms.
Participants will be divided randomly into two groups taking MHT drugs and placebo respectively and followed up for 12 months to collect relevant clinical data.
Detailed description
Cerebral small vessel disease (CSVD) is a common chronic whole brain syndrome in middle-aged and elderly people, mainly involving small-arteries, arterioles, capillaries, venules and small-veins in the brain. CSVD mainly relies on typical imaging features for diagnosis. Aging is the most common risk factor for CSVD. With the acceleration of China's aging process, the Disease burden of CSVD is increasing.
Menopause refers to the permanent cessation of menstruation caused by ovarian failure. During menopause, drastic changes in hormones can have a series of effects on women.Research shows that menopause is an independent risk factor for WMH. Meanwhile, menopause is significantly associated with cognitive impairment, especially with decreased learning, memory, and attention. Menopause can also cause changes in cerebral hemodynamics, damage to the integrity of the Blood-brain barrier and atrophy of cortical structures.
Estrogen not only plays a crucial role in maintaining vascular function, but also has significant neuro-protective effects. Estrogen-based menopausal hormone therapy (MHT) is essentially a treatment measure taken to compensate for ovarian failure caused by aging.
However, it is still unclear whether MHT can effectively alleviate CSVD symptoms and delay CSVD progression. The MHT treatment plan may also be an important reason for the inconsistent conclusions on the impact of MHT on cognitive function in various clinical studies. In previous clinical studies, the MHT regimen was oral estrogen (with or without Progestogen).
Based on the above research background, MHT, especially the MHT regimen using transdermal estrogen, may be an effective treatment method to improve and alleviate the rapid progression of CSVD in perimenopausal women(without contraindications). So far, there have been no RCT studies evaluating the effectiveness and safety of MHT in CSVD patients internationally. Therefore, more research is needed to provide stronger evidence and provide new directions and basis for the treatment of CSVD.
Participates who met the inclusion criteria were randomly divided into two groups. Participants were treated with MHT/placebo followed up for 12 months, and collected and analyzed relevant clinical data to evaluate the efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Estradiol Gel, Drug: Progesterone Soft CapsuleEstradiol gel 2.5 g (containing 17β estradiol 1.5mg) once daily (percutaneous application)* in combination with progesterone soft capsules 100mg once daily (oral) for 12 months Note : * Usage and dosage of estradiol gel: A dose of ruler is applied to the skin of the arm, shoulder, head and neck, abdomen, thigh or face every morning or evening. It is dry about two minutes after application. It is non-irritating, colorless, or milky white and tasteless, and is best used after bathing. |
| control group | Placebo comparator | Drug: Estradiol Placebo Gel, Drug: Progesterone Placebo Soft CapsuleEstradiol placebo gel 2.5g (containing 17β estradiol 0mg) once daily (percutaneous application) *in combination with progesterone placebo soft capsules(containing progesterone 0mg) 100mg once daily (oral) for 12 months Note : * Usage and dosage of estradiol placebo gel : A dose of ruler is applied to the skin of the arm, shoulder, head and neck, abdomen, thigh or face every morning or evening. It is dry about two minutes after application. It is non-irritating, colorless, or milky white and tasteless, and is best used after bathing. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- 40 ≤ age < 60 years
- Female;
- 1 year ≤ Natural menopause≤ 6 years;
- FSH ≥ 35 miu/ml and E2 ≤ 25 pg/ml;
- Head MRI shows CSVD-related image changes, meet one of the following:
Key exclusion criteria (23 listed)
- Inheritable CSVD, such as CADASIL, CARASIL, etc.
- Confirmed neurodegenerative diseases, such as AD and PD;
- Clear non-vascular white matter lesions, such as multiple sclerosis, adult brain white matter dysplasia, metabolic encephalopathy, etc.
- History of intracranial hemorrhagic disease within the recent 6 months, including cerebral parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural / extradural hematoma, etc., as well as untreated aneurysms (diameter> 3mm) and cerebrovascular malformations.
- Cardiovascular and cerebrovascular events within the past 6 months, such as myocardial infarction, unstable angina pectoris, cerebral infarction, etc.
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 |
|---|---|---|
| Estradiol GelEstradiol gel 2.5 g (containing 17β estradiol 1.5mg) once daily (percutaneous application) for 12 months | Drug | treatment group |
| Estradiol Placebo GelEstradiol placebo gel 2.5 g (containing 17β estradiol 1.5mg) once daily (percutaneous application) for 12 months | Drug | control group |
| Progesterone Soft CapsuleProgesterone soft capsules 100mg once daily (oral) for 12 months | Drug | treatment group |
| Progesterone Placebo Soft CapsuleProgesterone placebo soft capsules 100mg once daily (oral) for 12 months | Drug | control group |
Primary outcome
the changes in the Montreal Cognitive Assessment (MoCA; range, 0-30; with lower scores indicating more severe cognitive impairment) scores 1 year after randomization compared to baseline
Time frame: 1 year after randomization
the changes of the Montreal Cognitive Assessment (MoCA; range, 0-30; with lower scores indicating more severe cognitive impairment) scores
8 secondary outcomes
the changes in each cognitive domain estimated bythe Montreal Cognitive Assessment (MoCA; range, 0-30; with lower scores indicating more severe cognitive impairment) sub-items 1 year after randomization compared to baseline
Time frame: 1 year after randomization
the changes of modified Kupperman scores (0-63; with higher scores indicating more severe symptoms) 1 year after randomization compared to baseline
Time frame: 1 year after randomization
the changes of Pittsburgh sleep quality index(PSQI; with higher scores indicating more severe sleep quality) 1 year after randomization compared to baseline
Time frame: 1 year after randomization
the changes of Hamilton Depression Scale(HAMD; ranges, 0-54; with higher scores indicating more severe depression) 1 year after randomization compared to baseline
Time frame: 1 year after randomization
the changes of Hamilton Anxiety Scale(HAMA; ranges, 0-56; with higher scores indicating more severe anxiety) 1 year after randomization compared to baseline
Time frame: 1 year after randomization
the changes of the volume of white matter hyperintensity 1 year after randomization compared to baseline
Time frame: 1 year after randomization
Serum levels of estradiol 1 year after randomization compared to baseline
Time frame: 1 year after randomization
Serum levels of follicle stimulating hormone 1 year after randomization compared to baseline
Time frame: 1 year after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
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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.
yilong wang, MD,PhD principal investigator
Beiiing Tiantan 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 Estradiol Gel and Progesterone Soft Capsule in people with Cerebral Small Vessel Diseases and Postmenopausal Symptoms, run by Beijing Tiantan 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 19 inclusion and 23 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 8 Aug 2023. 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 yilong wang, MD,PhD (0086-010-67092222, yilong528@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the changes in the Montreal Cognitive Assessment (MoCA; range, 0-30; with lower scores indicating more severe cognitive impairment) scores 1 year after randomization compared to baseline (time frame: 1 year after randomization). 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 8 Aug 2023.