NCT03411291

Statins in Cerebral Blood Flow and Neuronal Activity--A Pilot Study

The Effect of Statins on Cerebral Blood Flow and Neural Activity-A Non-Randomized Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Specific Aim: Demonstrate that statins have an effect on cerebral blood flow and neuronal activity

Detailed description

A number of recent of recent studies suggests that statins, typically used to lower blood cholesterol have an effect on the brain. Patients treated with statins may have increased blood flow in the brain resulting in increased activity of the brain's neurons. The neuronal system is linked to memory. Brain magnetic resonance imaging (MRI) with magnetic resonance spectroscopy (MRS) and magnetic resonance perfusion (MRP) will be used to assess changes in neuronal activity in patients receiving statins vs. patients not receiving statins. This is a single-site non-randomized pilot study. The study will include twenty (20), healthy consenting patients between the ages of 45 and 65 who are candidates for statin therapy as determined by their cardiologist(s). Two imaging visits will be required, one magnetic resonance imaging with Magnetic Resonance Spectroscopy and Magnetic Resonance Perfusion at baseline and one magnetic resonance imaging with magnetic resonance Spectroscopy and Magnetic Resonance Perfusion three months later as described. Patients will have selected their course of clinical treatment prior to recruitment. Ten patients will have elected to start statin therapy with Lipitor and ten patients will have elected to initially lower their cholesterol levels with diet, independent of their participation in the study. Participants on the "statin arm" will receive a dose of 20 mg per day of Lipitor and will receive a baseline brain Magnetic Resonance Imaging with Magnetic Resonance Spectroscopy and Magnetic Resonance Perfusion prior to receiving Lipitor and follow-up brain Magnetic Resonance Imaging with Magnetic Resonance Spectroscopy and Magnetic Resonance Perfusion three months after beginning Lipitor. Participants on the "diet arm" will receive a baseline brain magnetic resonance imaging with Magnetic Resonance Spectroscopy and Magnetic Resonance Perfusion at the beginning of the study and follow-up brain magnetic resonance imaging with magnetic resonance spectroscopy and magnetic resonance perfusion three months later.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DEVICE	MRI, MR Spectroscopy, MR Perfusion	One brain MRI/MR Spectroscopy/MR Perfusion at baseline and one brain MR/MR Spectroscopy/MR Perfusion at 3 months.

Timeline

• Start date: 2007-04-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2018-01-26
• Last updated: 2018-02-19

Locations

1 site across 1 country: United States