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

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.

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Key information

Conditions

Ischemic White Matter Lesions (WMIL) Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Disease Cerebral Small Vessel Diseases Cerebrovascular Disorders Nervous System Diseases VCAM-1 Vascular Cell Adhesion Molecule-1 Vascular Diseases

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suzhou Hospital of Anhui Medical University

Suzhou, Anhui, 234000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atorvastatin 10 mg daily

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.

Other names: Atorvastatin calcium, ATV

Placebo matching atorvastatin

Drug

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Suzhou Municipal Hospital of Anhui Province

Other

Registry information

Official study title

Atorvastatin Mitigates WMH-Related Cognitive Impairment by Reducing VCAM-1: A Randomized, Double-Blind, Placebo-Controlled Study

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Aug 17, 2025
Registry last updated: Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed