Evaluate the Effect of Atorvastatin on Cerebrovascular Reactivity in Mild Cognitive Impairment (MCI)

Phase 2

Recruiting

• Conditions: Mild Cognitive Impairment
• Interventions: Drug: Atorvastatin Oral Tablet

• Registration Number: NCT04765137
• Lead Sponsor: Johns Hopkins University

Brief Summary

The purpose of this study is to evaluate the effect of atorvastatin on brain vessel reactivity and with it on blood flow in people with mild cognitive impairment.

Detailed Description

Participants are first being informed about potential benefits and risks of the study and are required to give written consent. After that participants will undergo detailed phone screen to determine eligibility for study entry. At week 0, participants who meet eligibility requirements will be prescribed atorvastatin (40 mg, once in the evening) in an open-label manner.

Study Timeline

• Study First Submitted: 2021-02-18
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-21
• Study Start: 2021-05-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12
• Primary Completion: 2025-07-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

• Taking a statin currently or have taken a statin in the last 6 months.
• Contraindications to taking a statin.
• Transplant patient taking cyclosporine.
• Unable to undergo MRI procedures (such as having an implanted pacemaker or defibrillator or stimulator or having non MRI compatible metal).
• Diagnosis of dementia by history.
• Current diagnosis of substance abuse.
• History of stroke or myocardial infarction in past 6 months.
• History of HIV.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Atorvastatin 40 mg	Atorvastatin Oral Tablet	Participants receive 40 mg atorvastatin orally daily in the evening.

Primary Outcome Measures

Name	Time	Method
Change of MRI whole brain cerebrovascular reactivity (wbCVR)	Baseline and 12 weeks	MRI based CVR is a newer technique that measures dilatory function of the microvessels which have been shown to be superior to measurement of Cerebral blood flow (CBF) and have also been shown to be low in participants with MCI.

Secondary Outcome Measures

Name	Time	Method
Change in cognitive function (global neurocognitive measure)	Baseline and 12 weeks	Assessed by Global neurocognitive measure.
Change in plasma exosomes	Baseline and 12 weeks	Endothelial-derived exosomes (EDE) reflect the neurochemistry of cerebrovascular endothelial cells, while neuronal-enriched extracellular vesicles (nEV) are associated with brain white matter hyperintensities.
Change in cognitive function (domain-specific neurocognitive measure)	Baseline and 12 weeks	Assessed by Domain-specific neurocognitive measure.

Trial Locations

Locations (1)

Johns Hopkins University, Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States