Clinical trial NCT03411291: Statins in Cerebral Blood Flow and Neuronal Activity--A Pilot Study
Official title: The Effect of Statins on Cerebral Blood Flow and Neural Activity-A Non-Randomized Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Keywords: Alzheimer's, magnetic resonance imaging
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 18
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 patients male and female

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.

Eligibility 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).

Primary outcomes:
measure: MRI Spectroscopy
timeFrame: 3 months
measure: MRI Perfusion
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center, S. Mark Taper Foundation Imaging Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Franklin G. Moser, M.D.
role: PRINCIPAL_INVESTIGATOR
References: