Ischemic White Matter Lesions (WMIL)NCT07128212
Atorvastatin Mitigates WMH-Related Cognitive Impairment by Reducing VCAM-1
A study testing Atorvastatin 10 mg daily in people with Ischemic White Matter Lesions (WMIL) and Cerebral Small Vessel Disease, run by Suzhou Municipal Hospital of Anhui Province at 1 site in China.
Trial summary
This prospective study will enroll patients younger than 60 years with ischemic white matter lesions (WMIL) and age-matched healthy controls. We will measure circulating endothelial-related biomarkers, including endothelial progenitor cells (EPCs), intercellular adhesion molecule-1 (ICAM-1), vascular cell adhesion… Read more about this study
- Who is it for?
- Ages 45 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic White Matter Lesions (WMIL), Cerebral Small Vessel Disease, Vascular Cell Adhesion Molecule-1
- What is being tested?
- Atorvastatin 10 mg daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 401 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2022
- Phase
- Interventional
- 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 45 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 45-60 years.
- Provides written informed consent.
- WMIL group: consecutive outpatients/inpatients from the Neurology Department of Suzhou Municipal Hospital, with WMIL confirmed by brain MRI. Diagnostic features: symmetric, diffusely distributed, ill-defined lesions in periventricular and subcortical white matter; iso- or hypointense on T1WI; hyperintense on T2WI and FLAIR.
- Control group: healthy individuals aged 45-60 years with brain MRI showing no intracranial lesions.
Who cannot join
- Acute intracerebral hemorrhage or acute infarction on brain MRI or CT.
- Central nervous system diseases that severely affect cognition, such as Alzheimer's disease or frontotemporal dementia.
- White matter lesions due to other causes (e.g., toxic, genetic, immune, infectious, neoplastic, radiation-related).
- Severe hepatic, renal, or cardiac insufficiency.
- Recent major surgery or severe trauma.
- History of psychiatric disorders that would preclude completion of study scales.
- Unable to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Atorvastatin Mitigates WMH-Related Cognitive Impairment by Reducing VCAM-1: A Randomized, Double-Blind, Placebo-Controlled Study
This prospective study will enroll patients younger than 60 years with ischemic white matter lesions (WMIL) and age-matched healthy controls. We will measure circulating endothelial-related biomarkers, including endothelial progenitor cells (EPCs), intercellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1), asymmetric dimethylarginine (ADMA), and homocysteine (Hcy). We will also assess transcription levels of ICAM-1, VCAM-1, and ADMA. All participants will be followed and managed for 2 years, with repeated assessments of endothelial biomarkers and their transcriptional levels, as well as clinical and imaging evaluations. The aims are to characterize changes in endothelial biomarkers in WMIL, to determine how these changes relate to clinical features and imaging progression, and to evaluate whether statins protect endothelial function-by modifying these biomarkers-and thereby help treat WMIL and slow its progression.
- Conditions
- Ischemic White Matter Lesions (WMIL), Cerebral Small Vessel Disease, Vascular Cell Adhesion Molecule-1, VCAM-1
- Being tested
- Atorvastatin 10 mg daily, Placebo matching atorvastatin
- Medical subject headings
- Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 10 mg dailyDrug
Also called Atorvastatin calcium, ATV
Oral atorvastatin 10 mg administered once daily at 18:00 (6 p.m.) for 24 months. Dose form: tablet. Route: oral. Indicated for participants with WMH. Adherence monitored by pill count and diary. No dose titration planned.
Placebo matching atorvastatinDrug
Placebo tablet matching atorvastatin in appearance and packaging, containing inactive excipients only; taken orally once daily at 18:00 for 24 months.
| Study group | Role | What they receive |
|---|---|---|
| WMH - Intervention | Experimental | Participants with WMH receiving oral atorvastatin 10 mg once daily at 18:00 (6 p.m.) for 24 months. Standard assessments will be performed at baseline and follow-up. Receives: Drug: Atorvastatin 10 mg daily |
| WMH - Placebo | Placebo comparator | Participants with WMH receiving a placebo tablet matching atorvastatin, administered orally once daily at 18:00 (6 p.m.) for the same duration as the intervention arm. The same assessments will be performed. Receives: Drug: Placebo matching atorvastatin |
| Health Control | No intervention | Health control participants with no study intervention; baseline and follow-up assessments only over the same schedule as patient groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
VACM1 levels at 0.5, 1.0, 1.5, and 2.0 years
Measured: 0.5, 1, 1.5, and 2.0 years after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Jan 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic White Matter Lesions (WMIL)Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Municipal Hospital of Anhui Province
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128212
- Sponsor's protocol ID
- SuzhouAnhuiWMH
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atorvastatin Mitigates WMH-Related Cognitive Impairment by Reducing VCAM-1: A Randomized, Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT07128212
- Acronym / sponsor ID
- SuzhouAnhuiWMH
- Conditions
- Ischemic White Matter Lesions (WMIL), Cerebral Small Vessel Disease, Vascular Cell Adhesion Molecule-1, VCAM-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Suzhou Municipal Hospital of Anhui ProvinceUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 17 Aug 2025 (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.
This prospective study will enroll patients younger than 60 years with ischemic white matter lesions (WMIL) and age-matched healthy controls. We will measure circulating endothelial-related biomarkers, including endothelial progenitor cells (EPCs), intercellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1), asymmetric dimethylarginine (ADMA), and homocysteine (Hcy). We will also assess transcription levels of ICAM-1, VCAM-1, and ADMA. All participants will be followed and managed for 2 years, with repeated assessments of endothelial biomarkers and their transcriptional levels, as well as clinical and imaging evaluations. The aims are to characterize changes in endothelial biomarkers in WMIL, to determine how these changes relate to clinical features and imaging progression, and to evaluate whether statins protect endothelial function-by modifying these biomarkers-and thereby help treat WMIL and slow its progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| WMH - Intervention | Experimental | Drug: Atorvastatin 10 mg dailyParticipants with WMH receiving oral atorvastatin 10 mg once daily at 18:00 (6 p.m.) for 24 months. Standard assessments will be performed at baseline and follow-up. |
| WMH - Placebo | Placebo comparator | Drug: Placebo matching atorvastatinParticipants with WMH receiving a placebo tablet matching atorvastatin, administered orally once daily at 18:00 (6 p.m.) for the same duration as the intervention arm. The same assessments will be performed. |
| Health Control | No intervention | –Health control participants with no study intervention; baseline and follow-up assessments only over the same schedule as patient groups. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 45-60 years.
- Provides written informed consent.
- WMIL group: consecutive outpatients/inpatients from the Neurology Department of Suzhou Municipal Hospital, with WMIL confirmed by brain MRI. Diagnostic features: symmetric, diffusely distributed, ill-defined lesions in periventricular and subcortical white matter; iso- or hypointense on T1WI; hyperintense on T2WI and FLAIR.
- Control group: healthy individuals aged 45-60 years with brain MRI showing no intracranial lesions.
Key exclusion criteria (7 listed)
- Acute intracerebral hemorrhage or acute infarction on brain MRI or CT.
- Central nervous system diseases that severely affect cognition, such as Alzheimer's disease or frontotemporal dementia.
- White matter lesions due to other causes (e.g., toxic, genetic, immune, infectious, neoplastic, radiation-related).
- Severe hepatic, renal, or cardiac insufficiency.
- Recent major surgery or severe trauma.
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 |
|---|---|---|
| Atorvastatin 10 mg dailyAlso: Atorvastatin calcium, ATVOral atorvastatin 10 mg administered once daily at 18:00 (6 p.m.) for 24 months. Dose form: tablet. Route: oral. Indicated for participants with WMH. Adherence monitored by pill count and diary. No dose titration planned. | Drug | WMH - Intervention |
| Placebo matching atorvastatinPlacebo tablet matching atorvastatin in appearance and packaging, containing inactive excipients only; taken orally once daily at 18:00 for 24 months. | Drug | WMH - Placebo |
Primary outcome
VACM1 levels at 0.5, 1.0, 1.5, and 2.0 years
Time frame: 0.5, 1, 1.5, and 2.0 years 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 17 Aug 2025.
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 study testing Atorvastatin 10 mg daily in people with Ischemic White Matter Lesions (WMIL) and Cerebral Small Vessel Disease, run by Suzhou Municipal Hospital of Anhui Province 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 4 inclusion and 7 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 17 Aug 2025. 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.
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?
VACM1 levels at 0.5, 1.0, 1.5, and 2.0 years (time frame: 0.5, 1, 1.5, and 2.0 years 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 17 Aug 2025.