Effect of Atorvastatin on Brain Blood Flow in Mild Cognitive Impairment
Targeting Cerebrovascular Reactivity for Precision Medicine: Pilot Trial of Atorvastatin
This study is testing if the cholesterol medicine atorvastatin can improve blood flow in the brains of people with mild cognitive impairment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 60 Years to 95 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT04765137 on ClinicalTrials.gov |
What this trial studies
This study evaluates how atorvastatin, a cholesterol-lowering medication, affects the reactivity of blood vessels in the brain and subsequently blood flow in individuals with mild cognitive impairment (MCI). Participants will be informed about the potential benefits and risks before providing written consent. Eligible participants will receive atorvastatin (40 mg) once daily in an open-label format, and their cognitive functions will be monitored throughout the study. The aim is to determine if atorvastatin can improve cerebrovascular health in this population.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with mild cognitive impairment who have vascular risk factors and are not currently taking statins.
Not a fit: Patients with a history of dementia, recent strokes, or those currently taking statins are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for improving brain blood flow and cognitive function in patients with mild cognitive impairment.
How similar studies have performed: Previous studies have explored the effects of statins on cognitive function, but this specific approach focusing on cerebrovascular reactivity in MCI is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 \> 1.5 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.
Where this trial is running
Baltimore, Maryland
- Johns Hopkins University, Bayview Medical Center — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Paul Rosenberg, MD — Johns Hopkins University
- Study coordinator: Samantha Horn
- Email: shorn8@jhmi.edu
- Phone: 410-550-9020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.