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

NCT ID: NCT04765137

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-21
• Study Completion Date: 2026-12-31

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Atorvastatin 40 mg

Participants receive 40 mg atorvastatin orally daily in the evening.

Group Type: EXPERIMENTAL

Atorvastatin Oral Tablet

Intervention Type: DRUG

Atorvastatin pill 40 mg to be taken every night

Interventions

Atorvastatin Oral Tablet

Atorvastatin pill 40 mg to be taken every night

Intervention Type: DRUG

Other Intervention Names

Lipitor oral tablet

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Richman Family Precision Medicine Center of Excellence in Alzheimer Disease

UNKNOWN

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Rosenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University, Bayview Medical Center

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Samantha Horn

Role: CONTACT

shorn8@jhmi.edu

410-550-9020

Ritu Agarwal

Role: CONTACT

ragarw19@jhmi.edu

410-550-9020

Facility Contacts

Samantha Horn

Role: primary

shorn8@jhmi.edu

410-550-9020

Ritu Agarwal

Role: backup

ragarw19@jhmi.edu

410-550-9020

Other Identifiers

IRB00256402

Identifier Type: -

Identifier Source: org_study_id