Alzheimer's DiseasePhase 4SimBioNCT01142336
Effects of Simvastatin on Biomarkers
A Phase 4 study testing Simvastatin in people with Alzheimer's Disease, run by University of Washington at 1 site in United States.
Trial summary
A year-long randomized, double-blind, placebo-controlled trial of simvastatin to see if it produces beneficial changes in cerebral spinal fluid proteins associated with Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 45 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Oct 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria (participants must meet the following criteria)
- If female of childbearing potential, must have negative pregnancy test at baseline, and all subsequent visits.
- Age 45 to 64 years inclusive.
- Considered cognitively normal with no evidence of memory or other cognitive impairments (MMSE >26, Logical Memory delayed recall > 6, CDR score of 0).
- Normal or only mildly elevated cholesterol which does not require drug therapy based on National Cholesterol Education Program Adult Treatment Panel III (NCEP/ATP-III) guidelines.
- An LDL level above 70mg/dL.
- Hamilton Depression Scale (HAM-D) score < 12.
- BMI between 18 - 34 (or exception made by MD).
- In good recent general health (i.e., no trauma or infection in the 4 weeks before LP).
- On stable dose of non-exclusionary medications for the 4 weeks preceding the LP.
- Platelet count >100,000.
Exclusion Criteria (participants must NOT satisfy any of the following conditions)
- Any contraindications to LP, such as spinal deformity, severe disease or infection in the LP region, bleeding tendency, anticoagulant or blood-thinning medications.
- Taken a statin medication in the past 12 months.
- Any clinically significant laboratory abnormalities.
- Any neurological disorders: multiple sclerosis, epilepsy, stroke, Parkinson's, other degenerative CNS disorders, or neuropathy with radicular involvement.
- Acute or chronic major psychiatric disorders: schizophrenia, affective disorders, or severe anxiety disorders. (Dysthymia allowed, history of MDD allowed if currently in remission)
- Unstable or poorly controlled medical problems such as: heart failure, diabetes (poorly controlled or insulin dependent), hypertension (BP >160/100), pulmonary disease with hypoxia or hypercapnia, significant liver disease or known hepatitis C seropositivity, renal failure, treatment for cancer in the past 2 years (other than non-melanoma skin cancer) or known HIV positive status.
- Use of illegal drugs or alcohol abuse (>2 drinks/day or 10/week) within the past year.
- Concurrent participation in another investigational drug study.
- Use of any exclusionary medications in the 4 weeks prior to screening:
- Drugs which could interact with statins: itraconazole, ketoconazole, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone, amiodarone, cyclosporine, isoniazid, quinidine, or large quantities of grapefruit juice (>1 quart daily)
- Central nervous system acting medications: antipsychotics, anti-Parkinson's disease medications, anti convulsants, or CNS stimulants
- Chronic use of benzodiazepines, sedating antihistamines, or other sedative-hypnotic agents (prn use is allowed as long as it is not within 72 hours of LP or cognitive testing)
- Medications affecting coagulation and/or inflammation: coumadin, potent anti-inflammatory medications (hydrocortisone, methotrexate or other potent immune-modulating medications), and anti-HIV medications (Aspirin up to 325 mg/day is allowed.)
- Lipid-lowering drugs: fibrates or niacin >500mg/day (stable dose of omega-3 is allowed)
- Does the subject's family history meet any of the following criteria?
- Both parents had/have dementia
- On one side of the family, over two consecutive generations three relatives had/have dementia?
- One parent had an onset of dementia before age 60?
- Does the subject have a major active autoimmune or immunological disorder?
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System
Seattle, Washington, 98108
About this study
Official title: Effects of Simvastatin on CSF AD Biomarkers in Cognitively Normal Subjects
A year-long randomized, double-blind, placebo-controlled trial of simvastatin to see if it produces beneficial changes in cerebral spinal fluid proteins associated with Alzheimer's disease.
Read the detailed description
The purpose of this study is to see if a drug called simvastatin (brand name Zocor) beneficially affects the level of certain molecules (such as proteins) in the spinal fluid of people. The molecules the investigators are measuring are thought to be important in the development of Alzheimer's disease (AD), and the investigators are testing whether simvastatin can change proteins to a level that is associated with a reduced risk for AD.
Simvastatin has been approved by the United States Food and Drug Administration (FDA) for the treatment of high cholesterol and to reduce the risk of coronary artery disease. It is an investigational drug in this study.
Participants will be randomly assigned to Placebo or Simvastatin. The investigators and the participant will be blinded. Randomization will be stratified by age and gender.
This study is being funded by the National Institute on Aging. The investigators will take part in this study at the VA Puget Sound Health Care System.
This study will last up to 1 year. Participants will be asked to come to the VA in Seattle a total of 9 times, 2 of those times will be for lumbar punctures (also known as a spinal tap).
The investigators would also like to ask a person who knows the participant well (such as a spouse, child, sibling, or good friend) some questions about the participant's health, memory, mood and behavior, and abilities to do daily tasks at the beginning and the end of the study.
Participants must be cognitively normal, healthy, willing to have a lumbar puncture, and not need or take any medications to control cholesterol.
- Conditions
- Alzheimer's Disease
- Being tested
- Simvastatin, Placebo
- Keywords
- Alzheimer's Disease, Prevention, Spinal Fluid, Biomarkers, Simvastatin
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Also called Zocor
Simvastatin 40mg qHS for 1 year
PlaceboDrug
Also called Sugar Pill
Placebo 1 tablet qHS for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin | Experimental | Simvastatin 40mg qHS for 1 year Receives: Drug: Simvastatin |
| Placebo | Placebo comparator | Placebo 1 tablet qHS for 1 year Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Aβ42 in Cerebrospinal Fluid (CSF) at 1 Year
CSF Aβ42 concentration were measured at baseline and after 1-year intervention.
Measured: 1-year change of CSF Aβ42 from baseline
Change From Baseline in CSF Total Tau at 1 Year
CSF total tau was measured at baseline and after 1-year of intervention
Measured: 1-yr change
Change From Baseline in CSF ptau181 at 1 Year
ptau 181 measured in CSF at baseline and after 1-year intervention
Measured: 1-year change from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Seattle Institute for Biomedical and Clinical Research, VA Puget Sound Health Care System
- Responsible party
- Principal investigator, Gail Li, University of Washington
- Investigators
- Gail Li, MD, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142336
- Sponsor's protocol ID
- 37373
- Other IDs
- 00183
- Acronym
- SimBio
- Status last verified
- Jun 2017
- First submitted
- 9 Jun 2010
- Last updated
- 28 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Simvastatin on CSF AD Biomarkers in Cognitively Normal Subjects
- ClinicalTrials.gov ID
- NCT01142336
- Acronym / sponsor ID
- SimBio / 37373
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, Prevention, Spinal Fluid, Biomarkers, Simvastatin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Seattle Institute for Biomedical and Clinical Research, VA Puget Sound Health Care System
- Study start
- Jun 2010
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 11 Jun 2010 (estimated)
- Results
- Posted 28 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A year-long randomized, double-blind, placebo-controlled trial of simvastatin to see if it produces beneficial changes in cerebral spinal fluid proteins associated with Alzheimer's disease.
Detailed description
The purpose of this study is to see if a drug called simvastatin (brand name Zocor) beneficially affects the level of certain molecules (such as proteins) in the spinal fluid of people. The molecules the investigators are measuring are thought to be important in the development of Alzheimer's disease (AD), and the investigators are testing whether simvastatin can change proteins to a level that is associated with a reduced risk for AD.
Simvastatin has been approved by the United States Food and Drug Administration (FDA) for the treatment of high cholesterol and to reduce the risk of coronary artery disease. It is an investigational drug in this study.
Participants will be randomly assigned to Placebo or Simvastatin. The investigators and the participant will be blinded. Randomization will be stratified by age and gender.
This study is being funded by the National Institute on Aging. The investigators will take part in this study at the VA Puget Sound Health Care System.
This study will last up to 1 year. Participants will be asked to come to the VA in Seattle a total of 9 times, 2 of those times will be for lumbar punctures (also known as a spinal tap).
The investigators would also like to ask a person who knows the participant well (such as a spouse, child, sibling, or good friend) some questions about the participant's health, memory, mood and behavior, and abilities to do daily tasks at the beginning and the end of the study.
Participants must be cognitively normal, healthy, willing to have a lumbar puncture, and not need or take any medications to control cholesterol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin | Experimental | Drug: SimvastatinSimvastatin 40mg qHS for 1 year |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 1 tablet qHS for 1 year |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| SimvastatinAlso: ZocorSimvastatin 40mg qHS for 1 year | Drug | Simvastatin |
| PlaceboAlso: Sugar PillPlacebo 1 tablet qHS for 1 year | Drug | Placebo |
Primary outcome
Change From Baseline in Aβ42 in Cerebrospinal Fluid (CSF) at 1 Year
Time frame: 1-year change of CSF Aβ42 from baseline
CSF Aβ42 concentration were measured at baseline and after 1-year intervention.
Change From Baseline in CSF Total Tau at 1 Year
Time frame: 1-yr change
CSF total tau was measured at baseline and after 1-year of intervention
Change From Baseline in CSF ptau181 at 1 Year
Time frame: 1-year change from baseline
ptau 181 measured in CSF at baseline and after 1-year intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gail Li, MD, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simvastatin in people with Alzheimer's Disease, run by University of Washington 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?
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 28 Jul 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Aβ42 in Cerebrospinal Fluid (CSF) at 1 Year (time frame: 1-year change of CSF Aβ42 from baseline). The study lists 3 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 28 Jul 2017.