Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04765137

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

60 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Johns Hopkins University, Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location status: Recruiting

Location contact

Paul Rosenberg, MD

PRINCIPAL_INVESTIGATOR

Ritu Agarwal

CONTACT

[email protected]

410-550-9020

Samantha Horn

CONTACT

[email protected]

410-550-9020

Sevil Yasar, MD, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Atorvastatin Oral Tablet

Drug

Atorvastatin pill 40 mg to be taken every night

Other names: Lipitor oral tablet

Primary outcomes

  1. Change of MRI whole brain cerebrovascular reactivity (wbCVR)

    Time frame: 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 outcomes

  1. Change in plasma exosomes

    Time frame: 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.

  2. Change in cognitive function (global neurocognitive measure)

    Time frame: Baseline and 12 weeks

    Assessed by Global neurocognitive measure.

  3. Change in cognitive function (domain-specific neurocognitive measure)

    Time frame: Baseline and 12 weeks

    Assessed by Domain-specific neurocognitive measure.

Study contacts

Contact information is provided by the study sponsor or research team.

Ritu Agarwal

CONTACT

[email protected]

410-550-9020

Samantha Horn

CONTACT

[email protected]

410-550-9020

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • The Richman Family Precision Medicine Center of Excellence in Alzheimer Disease

Registry information

Official study title

Targeting Cerebrovascular Reactivity for Precision Medicine: Pilot Trial of Atorvastatin

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Feb 21, 2021
Registry last updated
Jul 13, 2026

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.

Published trials that share one or more normalized conditions with this study.