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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60-95
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • Atorvastatin Oral Tablet

    Drug

    Atorvastatin pill 40 mg to be taken every night

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Atorvastatin 40 mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

Change in cognitive function (global neurocognitive measure)

Assessed by Global neurocognitive measure.

Time frame
Baseline and 12 weeks
3

Change in cognitive function (domain-specific neurocognitive measure)

Assessed by Domain-specific neurocognitive measure.

Time frame
Baseline and 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

The Richman Family Precision Medicine Center of Excellence in Alzheimer Disease

Collaborator