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

Last updated: July 10, 2024
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

2

Condition

Dementia

Mental Disability

Memory Loss

Treatment

Atorvastatin Oral Tablet

Clinical Study ID

NCT04765137
IRB00256402
  • Ages 60-95
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

  • MCI defined by Clinical Dementia Rating (CDR) of 0.5 or 1.0.

  • Memory, processing speed, executive function, language - cognitive scores > 1.5standard 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 ordelirium.

Exclusion

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 ordefibrillator 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.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Atorvastatin Oral Tablet
Phase: 2
Study Start date:
May 21, 2021
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Johns Hopkins University, Bayview Medical Center

    Baltimore, Maryland 21224
    United States

    Active - Recruiting

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