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

February 15, 2018 updated by: Franklin G. Moser, M.D., Cedars-Sinai Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center, S. Mark Taper Foundation Imaging Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

20 patients male and female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months
MRI Perfusion
Time Frame: 3 months
Changes in perfusion in areas of the brain linked to memory measured by DCS perfusion imaging
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Franklin G. Moser, M.D., Cedars-Sinai Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

January 24, 2018

First Posted (Actual)

January 26, 2018

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 15, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSMC IRB Pro00011194

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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