Alzheimer's DiseaseNCT03411291
Statins in Cerebral Blood Flow and Neuronal Activity--A Pilot Study
An observational study of Alzheimer's Disease, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
Specific Aim: Demonstrate that statins have an effect on cerebral blood flow and neuronal activity Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- MRI, MR Spectroscopy, MR Perfusion
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 20 patients male and female
Who may be able to join
- Otherwise healthy adults, male or female
- Age 45-65,
- Prior to treatment with any statin at a moderate or high dose -
Who cannot join
- Previous cerebral vascular accident,
- Traumatic brain injury,
- Subarachnoid hemorrhage,
- Vascular dementia,
- Alzheimer's Disease A
- Any other known vascular pathologies of the brain.
Show all 9Show fewer
- Patients taking and/or receiving other known cerebrovascular enhancing medication/herbs and/or treatment (examples: tPA, gingko, triple H therapy, stenting procedures, etc.)
- Previous neurosurgery or intracranial procedures.
- Contraindication to MRI (pacemaker, neurostimulator, other surgical implants or metals which would contraindicate MRI).
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center, S. Mark Taper Foundation Imaging Center
Los Angeles, California, 90048
About this study
Official title: 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
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- MRI, MR Spectroscopy, MR Perfusion
- Keywords
- Alzheimer's, magnetic resonance imaging
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI, MR Spectroscopy, MR PerfusionDevice
One brain MRI/MR Spectroscopy/MR Perfusion at baseline and one brain MR/MR Spectroscopy/MR Perfusion at 3 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MRI, MR Spectroscopy, MR Perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI Spectroscopy
Changes in metabolite concentration in areas of the brain linked to memory measured by MR spectroscopy with quantitative post processing
Measured: 3 months
MRI Perfusion
Changes in perfusion in areas of the brain linked to memory measured by DCS perfusion imaging
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study startApr 2007
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franklin G. Moser, M.D., Cedars-Sinai Medical Center
- Investigators
- Franklin G. Moser, M.D., Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411291
- Sponsor's protocol ID
- CSMC IRB Pro00011194
- Status last verified
- Feb 2018
- First submitted
- 26 Dec 2007
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Statins on Cerebral Blood Flow and Neural Activity-A Non-Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT03411291
- Acronym / sponsor ID
- CSMC IRB Pro00011194
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Device: MRI, MR Spectroscopy, MR PerfusionHealthy 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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20 patients male and female
Key inclusion criteria (3 listed)
- Otherwise healthy adults, male or female
- Age 45-65,
- Prior to treatment with any statin at a moderate or high dose -
Key exclusion criteria (9 listed)
- Previous cerebral vascular accident,
- Traumatic brain injury,
- Subarachnoid hemorrhage,
- Vascular dementia,
- Alzheimer's Disease A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI, MR Spectroscopy, MR PerfusionOne brain MRI/MR Spectroscopy/MR Perfusion at baseline and one brain MR/MR Spectroscopy/MR Perfusion at 3 months. | Device | Statin: MRI/MR Spectroscopy/MR Perfusion |
Primary outcome
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
MRI Perfusion
Time frame: 3 months
Changes in perfusion in areas of the brain linked to memory measured by DCS perfusion imaging
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Article: Amarenco P, Lavallée P \& Touboul P-J. (2004) Stroke prevention, blood cholesterol, and statin. Lancet Neurol 3: 271-278.Link provided by the sponsor.
- Review: Forsting M. Weber J. MR perfusion imaging: a tool for more than stroke.Link provided by the sponsor.
- Article: Brain microvascular changes in Alzheimer's disease and other dementias.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franklin G. Moser, M.D. principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI Spectroscopy (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.