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

Suzhou Municipal Hospital of Anhui Province

Status: Completed

Conditions: Cerebral Small Vessel Disease; Vascular Cell Adhesion Molecule-1; VCAM-1; Ischemic White Matter Lesions (WMIL)

Treatments: Drug: Atorvastatin 10 mg daily; Drug: Placebo matching atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT07128212

SuzhouAnhuiWMH

Details and patient eligibility

About

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.

Enrollment: 401 patients

Sex: All

Ages: 45 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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401 participants in 3 patient groups, including a placebo group

WMH - Intervention

Experimental group

Description:

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.

Treatment:

Drug: Atorvastatin 10 mg daily

WMH - Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo matching atorvastatin

Health Control

No Intervention group

Description:

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