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

NCT07128212 | Completed

• 1 other identifier: SuzhouAnhuiWMH
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• VACM1 levels at 0.5, 1.0, 1.5, and 2.0 years

  0.5, 1, 1.5, and 2.0 years after baseline

Study Arms (3)

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.

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.

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.

Interventions

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.

Also known as: Atorvastatin calcium, ATV

WMH - Intervention

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.

WMH - Placebo

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Municipal Hospital of Anhui Province: lead

Study Sites (1)

Suzhou Hospital of Anhui Medical University

Suzhou, Anhui, 234000, China

Location

MeSH Terms

Conditions

Cerebral Small Vessel Diseases

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

CN (1)