|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 12, 2007 | ||||
| Last Updated Date | June 30, 2009 | ||||
| Start Date ICMJE | February 2005 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Changes in cerebrospinal fluid beta-amyloid levels [ Time Frame: 9 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Changes in cerebrospinal fluid beta-amyloid levels [ Time Frame: 9 months ] | ||||
| Change History | Complete list of historical versions of study NCT00486044 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE |
|
||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluating Simvastatin's Potential Role in Therapy | ||||
| Official Title ICMJE | Effect of Statins on Pathobiology of Alzheimer's Disease | ||||
| Brief Summary | The purpose of this study is to see how simvastatin, a cholesterol lowering drug, affects processes related to the development of Alzheimer's disease, including: 1) levels of a substance called beta-amyloid 42 found in the fluid surrounding the brain, 2) blood flow in the brain, 3) inflammation in the brain, and 4) the brain's handling of cholesterol. |
||||
| Detailed Description | Some studies suggest that statin medications, which are a group of cholesterol-lowering medicines, may help prevent Alzheimer's disease. However, this has not been proven in humans. The purpose of this study is to see how simvastatin affects substances in the body called beta-amyloid 40 and beta-amyloid 42, as well as blood flow to the brain. These substances are found in both the brain and the fluid around the brain and spinal cord. High amounts of these substances may be associated with a greater risk of getting Alzheimer's disease. The ESPRIT study will include 100 middle-aged adults (35-69 yrs) who have a parent with documented Alzheimer's disease. This study will see how the use of a particular statin medication, simvastatin, affects spinal fluid levels of beta-amyloid, inflammation, and cholesterol. In addition, these changes will be compared to changes in memory and thinking skills monitored throughout the study. Fifty of the ESPRIT subjects will also participate in the MRI substudy, which is examining the effects of the study medication on blood flow to structures in the brain that are associated with Alzheimer's disease. Participants will take part in 5 visits (and an additional 2 visits, if participating in the MRI substudy) over the course of 9 months. Participants will undergo fasting blood tests (baseline, month 3, and month 9 visits), complete a medical history questionnaire (baseline), complete medication side effect review through questionnaire and/or blood sample (all visits), undergo lumbar puncture procedure (baseline and month 9 visits), complete memory testing (baseline, month 3 and month 9 visits), and MRI procedure (baseline and month 9 visits), if participating in MRI substudy. Participants will be randomly assigned to receive either simvastatin or a placebo each night for 9 months. |
||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Alzheimer Disease | ||||
| Intervention ICMJE |
|
||||
| Study Arms / Comparison Groups | |||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | June 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 35 Years to 69 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00486044 | ||||
| Responsible Party | Cynthia M. Carlsson, MD, MS, Assistant Professor of Medicine, University of Wisconsin School of Medicine and Public Health | ||||
| Study ID Numbers ICMJE | IA0116, 1K23AG026752-01 | ||||
| Study Sponsor ICMJE | National Institute on Aging (NIA) | ||||
| Collaborators ICMJE |
|
||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Institute on Aging (NIA) | ||||
| Verification Date | June 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||