An observational study in Alzheimer's Disease, sponsored by Cedars-Sinai Medical Center. Completed at 1 site in United States. Open to participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-02-19.
Sponsored by Cedars-Sinai Medical Center · Observational
Specific Aim: Demonstrate that statins have an effect on cerebral blood flow and neuronal activity
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.
20 patients male and female
Exclusion Criteria:
Healthy candidates for statin therapy to lower cholesterol pre-electing to lower cholesterol by diet for three months. Candidates in this arm have pre-elected to lower cholesterol by diet as described under the care of their treating physicians. Candidates will have 1 (one) brain MRI / MR spectroscopy/MR resonance perfusion scan at baseline and 1 (one) brain MRI / MR spectroscopy/MR resonance perfusion scan at 3 (three) months.
Healthy candidates for statin therapy pre-electing to lower their cholesterol using atorvastatin (Lipitor) 20 mg per day as prescribed by their treating physician per standard of care. There are no research-related interventions for this group. Candidates will have 1 (one) brain MRI / MR spectroscopy/MR resonance perfusion scan at baseline and 1 brain MRI / MR spectroscopy/MR resonance perfusion scan at 3 months.
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.
MRI Spectroscopy
Changes in metabolite concentration in areas of the brain linked to memory measured by MR spectroscopy with quantitative post processing
Time frame: 3 months
MRI Perfusion
Changes in perfusion in areas of the brain linked to memory measured by DCS perfusion imaging
Time frame: 3 months
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Cedars-Sinai Medical Center