Evaluate the Effect of Atorvastatin on Cerebrovascular Reactivity in MCI

Mild Cognitive Impairment Clinical Trial

Official title:

Targeting Cerebrovascular Reactivity for Precision Medicine: Pilot Trial of Atorvastatin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04765137
• Other study ID #: IRB00256402
• Status: Recruiting
• Phase: Phase 2
• Start date: May 21, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Johns Hopkins University
• Contact: Samantha Horn
• Phone: 410-550-9020
• Email: shorn8[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 95 Years

Eligibility

Inclusion Criteria are chosen to include participants with MCI, enriched for vascular risk

factors:

• MCI defined by 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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Drug:
• Atorvastatin Oral Tablet
Atorvastatin pill 40 mg to be taken every night

Locations

Country	Name	City	State
United States	Johns Hopkins University, Bayview Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 12 weeks
Secondary	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.	Baseline and 12 weeks
Secondary	Change in cognitive function (global neurocognitive measure)	Assessed by Global neurocognitive measure.	Baseline and 12 weeks
Secondary	Change in cognitive function (domain-specific neurocognitive measure)	Assessed by Domain-specific neurocognitive measure.	Baseline and 12 weeks