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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411291
• Other study ID #: CSMC IRB Pro00011194
• Status: Completed
• Phase: N/A
• First received: December 26, 2007
• Last updated: February 15, 2018
• Start date: April 2007
• Est. completion date: September 2010

Study information

• Verified date: February 2018
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center, S. Mark Taper Foundation Imaging Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI Spectroscopy	Changes in metabolite concentration in areas of the brain linked to memory measured by MR spectroscopy with quantitative post processing	3 months
Primary	MRI Perfusion	Changes in perfusion in areas of the brain linked to memory measured by DCS perfusion imaging	3 months

External Links

•   Article: Amarenco P, Lavallée P & Touboul P-J. (2004) Stroke prevention, blood cholesterol, and statin. Lancet Neurol 3: 271-278.
•   Article: Brain microvascular changes in Alzheimer's disease and other dementias.
•   Review: Forsting M. Weber J. MR perfusion imaging: a tool for more than stroke.