Cerebral and Peripheral Perfusion Pilot Study
CAPP
Impact of Atorvastatin on Cerebral Perfusion and Endothelial Function
3 other identifiers
interventional
16
1 country
1
Brief Summary
The purpose of this study is to evaluate the hypothesis that in middle-aged, asymptomatic, adult children of persons with Alzheimer's disease (AD), atorvastatin therapy will beneficially affect mechanisms thought to contribute to AD risk by improving blood flow in the brain, improving cerebral perfusion, increasing brain activity patterns, and improving blood vessel function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2006
Shorter than P25 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
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 10, 2008
CompletedFirst Posted
Study publicly available on registry
September 12, 2008
CompletedSeptember 9, 2019
September 1, 2019
10 months
September 10, 2008
September 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in regional cerebral blood flow (rCBF)
rCBF , a measure of cerebral perfusion, is the primary outcome. rCBF was measured by arterial spin-labeling magnetic resonance imaging and used to evaluate effects of atorvastatin vs placebo
Baseline and 4 months
Secondary Outcomes (1)
Change in Endothelial function
Baseline and 4 months
Study Arms (2)
Atorvastatin
EXPERIMENTAL40mg Atorvastatin nightly for 4 months
Placebo
PLACEBO COMPARATORmatching placebo nightly for 4 months
Interventions
Eligibility Criteria
You may qualify if:
- Adult (ages 40-65) children of parent with documented Alzheimer's disease
You may not qualify if:
- Current use of cholesterol lowering medication
- History of liver disease
- History of adverse reaction to statin medications
- Elevated lab values (CK and creatinine)
- Use of medications that counteract with atorvastatin
- History of dementia
- Currently pregnant
- Use of large quantities of grapefruit juice (more than 1 quart/day)
- Current involvement in another investigational drug study
- Contraindications to MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karen Lazar
Madison, Wisconsin, 53705, United States
Related Publications (6)
Newman GC, Delucia-Deranja E, Tudorica A, Hospod FE, Patlak CS. Cerebral blood volume measurements by T*2-weighted MRI and contrast infusion. Magn Reson Med. 2003 Oct;50(4):844-55. doi: 10.1002/mrm.10591.
PMID: 14523972BACKGROUNDSorensen KE, Celermajer DS, Spiegelhalter DJ, Georgakopoulos D, Robinson J, Thomas O, Deanfield JE. Non-invasive measurement of human endothelium dependent arterial responses: accuracy and reproducibility. Br Heart J. 1995 Sep;74(3):247-53. doi: 10.1136/hrt.74.3.247.
PMID: 7547018BACKGROUNDWassmann S, Ribaudo N, Faul A, Laufs U, Bohm M, Nickenig G. Effect of atorvastatin 80 mg on endothelial cell function (forearm blood flow) in patients with pretreatment serum low-density lipoprotein cholesterol levels <130 mg/dl. Am J Cardiol. 2004 Jan 1;93(1):84-8. doi: 10.1016/j.amjcard.2003.09.018.
PMID: 14697473BACKGROUNDStein JH, Keevil JG, Wiebe DA, Aeschlimann S, Folts JD. Purple grape juice improves endothelial function and reduces the susceptibility of LDL cholesterol to oxidation in patients with coronary artery disease. Circulation. 1999 Sep 7;100(10):1050-5. doi: 10.1161/01.cir.100.10.1050.
PMID: 10477529BACKGROUNDSever PS, Dahlof B, Poulter NR, Wedel H, Beevers G, Caulfield M, Collins R, Kjeldsen SE, Kristinsson A, McInnes GT, Mehlsen J, Nieminen M, O'Brien E, Ostergren J; ASCOT investigators. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial. Lancet. 2003 Apr 5;361(9364):1149-58. doi: 10.1016/S0140-6736(03)12948-0.
PMID: 12686036BACKGROUNDCarlsson CM, Xu G, Wen Z, Barnet JH, Blazel HM, Chappell RJ, Stein JH, Asthana S, Sager MA, Alsop DC, Rowley HA, Fain SB, Johnson SC. Effects of atorvastatin on cerebral blood flow in middle-aged adults at risk for Alzheimer's disease: a pilot study. Curr Alzheimer Res. 2012 Oct;9(8):990-7. doi: 10.2174/156720512803251075.
PMID: 22175654RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cynthia M. Carlsson, MD, MS
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2008
First Posted
September 12, 2008
Study Start
June 1, 2006
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
September 9, 2019
Record last verified: 2019-09