|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
University of Wisconsin, Madison |
|---|---|
| Information provided by: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT00939822 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Alzheimer's Disease |
Drug: Simvastatin, Placebo |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
| Official Title: | Statin Effects on Beta-Amyloid and Cerebral Perfusion in Adults at Risk for AD: "Statins in Healthy, At-Risk Adults: Impact on Amyloid and Regional Perfusion (SHARP)" Study |
| Estimated Enrollment: | 90 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Simvastatin: Experimental |
Drug: Simvastatin, Placebo
Simvastatin 40 mg/day
|
| Sugar pill: Placebo Comparator |
Drug: Simvastatin, Placebo
Simvastatin 40 mg/day
|
Studies show that some medicines that lower cholesterol may reduce the risk of developing Alzheimer's disease, but this has not yet been proven in humans. We are looking for individuals to participate in this study to see if a cholesterol-lowering medication, called simvastatin affects blood flow to the brain, blood vessel function and a substance in the spinal fluid related to the changes in Alzheimer's disease.
The SHARP study will include 90 adults ages 45-65 who have a parent with documented Alzheimer's disease.
Participants will take part in 9 visits over the course of 18 months. Participants will undergo fasting blood tests, complete a medical history questionnaire, complete medication side effect review through questionnaire, undergo lumbar puncture procedure, complete memory testing, ultrasound and MRI procedure. Participants will be randomly assigned to receive either simvastatin or a placebo each night for 18 months.
Eligibility| Ages Eligible for Study: | 45 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Klaren S Pe-Romashko, MS | 608 256-1901 ext 11199 | kspromashko@medicine.wisc.edu |
| Contact: Hanna M. Blazel, MS | 608 256-1901 ext 11692 | hmb@medicine.wisc.edu |
| United States, Wisconsin | |
| University of Wisconsin-Madison | Recruiting |
| Madison, Wisconsin, United States, 53705 | |
| Principal Investigator: Cynthia M. Carlsson, MD, MS | |
| Principal Investigator: | Cynthia M. Carlsson, MD, MS | UW Madison School of Medicine and Public Health |
More Information
| Responsible Party: | UW-Madison School of Medicine and Public Health ( Cynthia M. Carlsson, MD, MS ) |
| Study ID Numbers: | H-2009-0030, RO1-AG031790-01A1 |
| Study First Received: | July 14, 2009 |
| Last Updated: | July 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00939822 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Antimetabolites Simvastatin Antilipemic Agents Alzheimer Disease Central Nervous System Diseases Anticholesteremic Agents Healthy Brain Diseases |
Neurodegenerative Diseases Hydroxymethylglutaryl-CoA Reductase Inhibitors Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Dementia Delirium |
|
Antimetabolites Molecular Mechanisms of Pharmacological Action Simvastatin Antilipemic Agents Alzheimer Disease Nervous System Diseases Central Nervous System Diseases Enzyme Inhibitors Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Brain Diseases Neurodegenerative Diseases Pharmacologic Actions Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Therapeutic Uses Dementia Tauopathies |
