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Evaluate the Effect of Atorvastatin on Cerebrovascular Reactivity in MCI

Primary Purpose

Mild Cognitive Impairment

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Atorvastatin Oral Tablet

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Cerebral Vascular Reactivity

Eligibility Criteria

60 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Johns Hopkins University, Bayview Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Atorvastatin 40 mg

Arm Description

Participants receive 40 mg atorvastatin orally daily in the evening.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Change in cognitive function (global neurocognitive measure)

Assessed by Global neurocognitive measure.

Change in cognitive function (domain-specific neurocognitive measure)

Assessed by Domain-specific neurocognitive measure.

Full Information

NCT ID

NCT04765137

First Posted

February 18, 2021

Last Updated

July 6, 2023

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT04765137

Brief Title

Evaluate the Effect of Atorvastatin on Cerebrovascular Reactivity in MCI

Official Title

Targeting Cerebrovascular Reactivity for Precision Medicine: Pilot Trial of Atorvastatin

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 21, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

Keywords

Cerebral Vascular Reactivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Open-label study with atorvastatin 40 mg

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Atorvastatin 40 mg

Arm Type

Experimental

Arm Description

Participants receive 40 mg atorvastatin orally daily in the evening.

Intervention Type

Drug

Intervention Name(s)

Atorvastatin Oral Tablet

Other Intervention Name(s)

Lipitor oral tablet

Intervention Description

Atorvastatin pill 40 mg to be taken every night

Primary Outcome Measure Information:

Title

Change of MRI whole brain cerebrovascular reactivity (wbCVR)

Description

Time Frame

Baseline and 12 weeks

Secondary Outcome Measure Information:

Title

Change in plasma exosomes

Description

Time Frame

Baseline and 12 weeks

Title

Change in cognitive function (global neurocognitive measure)

Description

Assessed by Global neurocognitive measure.

Time Frame

Baseline and 12 weeks

Title

Change in cognitive function (domain-specific neurocognitive measure)

Description

Assessed by Domain-specific neurocognitive measure.

Time Frame

Baseline and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Samantha Horn

Phone

410-550-9020

shorn8@jhmi.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Ritu Agarwal

Phone

410-550-9020

ragarw19@jhmi.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sevil Yasar, MD, PhD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins University, Bayview Medical Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Samantha Horn

Phone

410-550-9020

shorn8@jhmi.edu

First Name & Middle Initial & Last Name & Degree

Ritu Agarwal

Phone

410-550-9020

ragarw19@jhmi.edu

First Name & Middle Initial & Last Name & Degree

Sevil Yasar, MD, PhD

First Name & Middle Initial & Last Name & Degree

Paul Rosenberg, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Evaluate the Effect of Atorvastatin on Cerebrovascular Reactivity in MCI

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