This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The objective of this study is to evaluate the safety and efficacy of simvastatin to slow the progression of Alzheimer's disease. This is a randomized, double-blind, placebo-controlled, parallel group design with equal randomization to drug and placebo. 400 subjects will be enrolled from approximately 40 sites with a goal of 10 to 15 subjects enrolled at each site. Subjects will be patients with mild to moderate Alzheimer's disease who do not require lipid lowering treatment according to current guidelines. Study medication will be prepared as follows: 20 mg of simvastatin or matching placebo will be given for a period of 6 weeks followed by 40 mg of simvastatin or matching placebo for the remainder of the 18 months. The primary outcome measure will be change on the ADAScog over 18 months.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR020359-02
Application #
7376128
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2005-12-01
Project End
2006-11-30
Budget Start
2005-12-01
Budget End
2006-11-30
Support Year
2
Fiscal Year
2006
Total Cost
$4,646
Indirect Cost
Name
Children's Research Institute
Department
Type
DUNS #
143983562
City
Washington
State
DC
Country
United States
Zip Code
20010
Sady, Maegan D; Vaughan, Christopher G; Gioia, Gerard A (2018) Measuring Dynamic Symptom Response in Concussion: Children's Exertional Effects Rating Scale. J Head Trauma Rehabil :
Mullins, Tanya L Kowalczyk; Li, Su X; Bethel, James et al. (2018) Sexually transmitted infections and immune activation among HIV-infected but virally suppressed youth on antiretroviral therapy. J Clin Virol 102:7-11
Kahn, Jessica A; Xu, Jiahong; Kapogiannis, Bill G et al. (2017) Brief Report: Antibody Responses to Quadrivalent HPV Vaccination in HIV-Infected Young Women as Measured by Total IgG and Competitive Luminex Immunoassay. J Acquir Immune Defic Syndr 75:241-245
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Gioia, Gerard A (2016) Medical-School Partnership in Guiding Return to School Following Mild Traumatic Brain Injury in Youth. J Child Neurol 31:93-108
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Ruan, Alexandra; Tobin, Nicole H; Mulligan, Kathleen et al. (2016) Brief Report: Macrophage Activation in HIV-Infected Adolescent Males Contributes to Differential Bone Loss by Sex: Adolescent Trials Network Study 021. J Acquir Immune Defic Syndr 72:372-5
Orrock, Janet E; Panchapakesan, Karuna; Vezina, Gilbert et al. (2016) Association of brain injury and neonatal cytokine response during therapeutic hypothermia in newborns with hypoxic-ischemic encephalopathy. Pediatr Res 79:742-7
Sepeta, Leigh N; Berl, Madison M; Wilke, Marko et al. (2016) Age-dependent mesial temporal lobe lateralization in language fMRI. Epilepsia 57:122-30

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