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

NCT04765137 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IRB00256402
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

Cerebral Vascular Reactivity

Outcome Measures

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.

  Baseline and 12 weeks

Secondary Outcomes (3)

• Change in plasma exosomes

  Baseline and 12 weeks

• Change in cognitive function (global neurocognitive measure)

  Baseline and 12 weeks

• Change in cognitive function (domain-specific neurocognitive measure)

  Baseline and 12 weeks

Study Arms (1)

Atorvastatin 40 mg

EXPERIMENTAL

Participants receive 40 mg atorvastatin orally daily in the evening.

Drug: Atorvastatin Oral Tablet

Interventions

Atorvastatin Oral Tablet DRUG

Atorvastatin pill 40 mg to be taken every night

Also known as: Lipitor oral tablet

Atorvastatin 40 mg

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• The Richman Family Precision Medicine Center of Excellence in Alzheimer Disease: collaborator

Study Sites (1)

Johns Hopkins University, Bayview Medical Center

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Paul Rosenberg, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Horn

CONTACT

410-550-9020; shorn8@jhmi.edu

Ritu Agarwal

CONTACT

410-550-9020; ragarw19@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label study with atorvastatin 40 mg

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: May 21, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)