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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03411291
Enrollment
18
Registered
2018-01-26
Start date
2007-04-30
Completion date
2010-09-30
Last updated
2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Alzheimer's, magnetic resonance imaging

Brief 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.

Interventions

DEVICEMRI, MR Spectroscopy, MR Perfusion

One brain MRI/MR Spectroscopy/MR Perfusion at baseline and one brain MR/MR Spectroscopy/MR Perfusion at 3 months.

Sponsors

Cedars-Sinai Medical Center
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
MRI Spectroscopy3 monthsChanges in metabolite concentration in areas of the brain linked to memory measured by MR spectroscopy with quantitative post processing
MRI Perfusion3 monthsChanges in perfusion in areas of the brain linked to memory measured by DCS perfusion imaging

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026