Statin Effects on Beta-Amyloid and Cerebral Perfusion in Adults at Risk for Alzheimer's Disease
SHARP
4 other identifiers
interventional
88
1 country
1
Brief Summary
The purpose of the research is to see how simvastatin affects a substance in the body called beta-amyloid. Beta-amyloid is found in the brain and in the liquid around the brain and spinal cord. High amounts of beta-amyloid may be associated with a greater risk of getting Alzheimer's disease. This study will see if simvastatin can lower the amount of beta-amyloid in the spinal fluid. This study will also see if simvastatin affects memory and thinking, blood flow in the brain, and blood vessel function. The investigators hope that future studies show whether simvastatin might prevent memory loss and decrease the chance of developing Alzheimer's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2009
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 14, 2009
CompletedFirst Posted
Study publicly available on registry
July 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedResults Posted
Study results publicly available
August 9, 2019
CompletedAugust 9, 2019
August 1, 2019
4.5 years
July 14, 2009
June 14, 2019
August 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in Cerebrospinal Fluid (CSF) Beta-amyloid-42 Levels Compared to Baseline as Measured by xMAP
Change in CSF beta-amyloid-42 was defined as the ratio of 18-month levels to baseline levels. Beta-amyloid-42 is a substance found in the plaques in the brain of people with Alzheimer's disease and can be detected in CSF. There is no defined normal range yet for middle-aged adults.
Baseline and 18 months
Secondary Outcomes (3)
Changes in CSF Beta-amyloid-40 Levels as Measured by xMAP (Multi-Analyte Profiling) )
Baseline and 18 months
Changes in CSF Soluble Alpha Precursor Proteins (sAPP-alpha) and Soluble Beta Precursor Proteins (sAPP-beta) as Measured by Duplex
Baseline and 18 months
Changes in CSF Total Tau (T-tau) and Phosphorylated Tau (P-tau) as Measured by xMAP
Baseline and 18 months
Study Arms (2)
Simvastatin
EXPERIMENTAL40 mg. Simvastatin/day
Placebo
PLACEBO COMPARATORMatching Placebo
Interventions
Eligibility Criteria
You may qualify if:
- Parent diagnosed with Alzheimer's disease
- Age 40-72
You may not qualify if:
- Active liver disease
- History of adverse reaction to statins
- Contraindication to lumbar puncture
- Elevated creatine kinase and creatinine lab values
- Use of medications known to interact with statins
- History of dementia or mild cognitive impairment
- Currently pregnant or planning to become pregnant
- Use of large quantities of grapefruit juice (more than 1 quart per day)
- Contraindications to MRI (for MRI sub-study)
- Currently on cholesterol-lowering medication or use in past 4 months
- History of heart attack, heart problems, stroke and/or diabetes
- Drinking more than a quart of grapefruit juice per day
- Metal implants, or metal debris in body (MRI)
- List of medications that interact with simvastatin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karen Lazar
Fitchburg, Wisconsin, 53711, United States
Related Publications (2)
Vogt NM, Hunt JFV, Ma Y, Van Hulle CA, Adluru N, Chappell RJ, Lazar KK, Jacobson LE, Austin BP, Asthana S, Johnson SC, Bendlin BB, Carlsson CM. Effects of simvastatin on white matter integrity in healthy middle-aged adults. Ann Clin Transl Neurol. 2021 Aug;8(8):1656-1667. doi: 10.1002/acn3.51421. Epub 2021 Jul 18.
PMID: 34275209DERIVEDGepner AD, Lazar K, Hulle CV, Korcarz CE, Asthana S, Carlsson CM. Effects of Simvastatin on Augmentation Index Are Transient: Outcomes From a Randomized Controlled Trial. J Am Heart Assoc. 2019 Oct 15;8(20):e009792. doi: 10.1161/JAHA.118.009792. Epub 2019 Oct 12.
PMID: 31607205DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Cynthia M. Carlsson
- Organization
- University of Wisconsin School of Medicine and Public Health
Study Officials
- PRINCIPAL INVESTIGATOR
Cynthia M. Carlsson, MD, MS
UW Madison School of Medicine and Public Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2009
First Posted
July 15, 2009
Study Start
March 1, 2009
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
August 9, 2019
Results First Posted
August 9, 2019
Record last verified: 2019-08