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

Phase 2RecruitingNCT04765137

Johns Hopkins University20 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mild Cognitive Impairment

Interventions

Atorvastatin Oral TabletDRUG

Atorvastatin pill 40 mg to be taken every night

Eligibility

Sex: ALLMin age: 60 YearsMax age: 95 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria are chosen to include participants with MCI, enriched for vascular risk factors: * MCI defined by Clinical Dementia Rating (CDR) of 0.5 or 1.0. * Memory, processing speed, executive function, language - cognitive scores \> 1.5 standard deviations below age-education norms. * Not demented by history. * Not taking statins currently or in the last 6 months. * Cognitive/functional impairment not likely due to another neurological disease or delirium. 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.

Locations (1)

Johns Hopkins University, Bayview Medical Center

Baltimore, Maryland, United States

RECRUITING

Outcomes

Primary Outcomes

Change of MRI whole brain cerebrovascular reactivity (wbCVR)

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.

Time frame: Baseline and 12 weeks

Secondary Outcomes

Change in plasma exosomes

Endothelial-derived exosomes (EDE) reflect the neurochemistry of cerebrovascular endothelial cells, while neuronal-enriched extracellular vesicles (nEV) are associated with brain white matter hyperintensities.

Time frame: Baseline and 12 weeks

Change in cognitive function (global neurocognitive measure)

Assessed by Global neurocognitive measure.

Time frame: Baseline and 12 weeks

Change in cognitive function (domain-specific neurocognitive measure)

Assessed by Domain-specific neurocognitive measure.

Time frame: Baseline and 12 weeks

Central Contacts

Samantha Horn

CONTACT

410-550-9020 shorn8@jhmi.edu

Ritu Agarwal

CONTACT

410-550-9020 ragarw19@jhmi.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.