Trials / Completed
CompletedNCT07128212
Atorvastatin Mitigates WMH-Related Cognitive Impairment by Reducing VCAM-1
Atorvastatin Mitigates WMH-Related Cognitive Impairment by Reducing VCAM-1: A Randomized, Double-Blind, Placebo-Controlled Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 401 (actual)
- Sponsor
- Suzhou Municipal Hospital of Anhui Province · Academic / Other
- Sex
- All
- Age
- 45 Years – 60 Years
- Healthy volunteers
- Accepted
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 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Atorvastatin 10 mg daily | 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. |
| DRUG | Placebo matching atorvastatin | Placebo tablet matching atorvastatin in appearance and packaging, containing inactive excipients only; taken orally once daily at 18:00 for 24 months. |
Timeline
- Start date
- 2021-01-01
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
- First posted
- 2025-08-17
- Last updated
- 2025-08-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07128212. Inclusion in this directory is not an endorsement.