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

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ClinicalTrials.gov Identifier: NCT03411291
Recruitment Status : Completed
First Posted : January 26, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Franklin G. Moser, M.D., Cedars-Sinai Medical Center

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

Condition or disease Intervention/treatment
Alzheimer's Disease Device: MRI, MR Spectroscopy, MR Perfusion

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.

Study Design
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Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Effect of Statins on Cerebral Blood Flow and Neural Activity-A Non-Randomized Pilot Study
Study Start Date : April 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Diet: MRI/MR Spectroscopy/MR Perfusion
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.
Statin: MRI/MR Spectroscopy/MR Perfusion
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.


Outcome Measures
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Primary Outcome Measures :
  1. MRI Spectroscopy [ Time Frame: 3 months ]
    Changes in metabolite concentration in areas of the brain linked to memory measured by MR spectroscopy with quantitative post processing

  2. MRI Perfusion [ Time Frame: 3 months ]
    Changes in perfusion in areas of the brain linked to memory measured by DCS perfusion imaging


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
20 patients male and female
Criteria

Inclusion Criteria:

  1. Otherwise healthy adults, male or female
  2. Age 45-65,
  3. Prior to treatment with any statin at a moderate or high dose -

Exclusion Criteria:

  1. Previous cerebral vascular accident,
  2. Traumatic brain injury,
  3. Subarachnoid hemorrhage,
  4. Vascular dementia,
  5. Alzheimer's Disease A
  6. Any other known vascular pathologies of the brain.
  7. Patients taking and/or receiving other known cerebrovascular enhancing medication/herbs and/or treatment (examples: tPA, gingko, triple H therapy, stenting procedures, etc.)
  8. Previous neurosurgery or intracranial procedures.
  9. Contraindication to MRI (pacemaker, neurostimulator, other surgical implants or metals which would contraindicate MRI).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03411291


Locations
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United States, California
Cedars-Sinai Medical Center, S. Mark Taper Foundation Imaging Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Franklin G. Moser, M.D. Cedars-Sinai Medical Center
More Information
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Additional Information:

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Responsible Party: Franklin G. Moser, M.D., Director, Neuro-Interventional Imaging; Vice-Chair, Radiology Research, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03411291    
Other Study ID Numbers: CSMC IRB Pro00011194
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Keywords provided by Franklin G. Moser, M.D., Cedars-Sinai Medical Center:
Alzheimer's, magnetic resonance imaging
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders