Atorvastatin Mitigates WMH-Related Cognitive Impairment by Reducing VCAM-1

NCT ID: NCT07128212

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 401 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

WMH - Intervention

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.

Group Type: EXPERIMENTAL

Atorvastatin 10 mg daily

Intervention Type: DRUG

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.

WMH - Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo matching atorvastatin

Intervention Type: DRUG

Placebo tablet matching atorvastatin in appearance and packaging, containing inactive excipients only; taken orally once daily at 18:00 for 24 months.

Health Control

Health control participants with no study intervention; baseline and follow-up assessments only over the same schedule as patient groups.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Atorvastatin calcium; ATV

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Suzhou Municipal Hospital of Anhui Province

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Suzhou Hospital of Anhui Medical University

Suzhou, Anhui, China

Countries

China

Other Identifiers

SuzhouAnhuiWMH

Identifier Type: -

Identifier Source: org_study_id