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. This study involves use of an investigational drug called MPC-7869, which has not been approved by the U.S. Food and Drug Administration (FDA). MPC-7869 is experimental. Myriad Pharmaceuticals, Inc. sponsors this study. Its purpose is to look at the effectiveness of MPC-7869 compared to placebo (a medically inactive substance) on the cognition (thinking and memory), general mental performance, and activities of daily living in subjects with Alzheimer's disease. Additionally, at Visit 2, subjects will have the option of participating in a genetic sub study that involves an additional blood sample. A separate Informed Consent Form (ICF) exists for that substudy. The study is being conducted at 130 sites. Approximately 10-12 patients will be enrolled at each site. In total, we expect about 1600-1700 patients to enter this study. The study lasts about 20 months in total. 10 study visits and 10 telephone contacts take place over the course of the study. Study visits may take up to 3 hours. After an initial screening visit to check on the subject's suitability to participate, individuals will be placed in one of two treatment groups for the entire study. Subjects will have a 1 in 2 chance (50%) of being assigned to either study group. Neither the subject nor the study doctor will know which study group an individual is in The study doctor can find out which study drug a subject is taking in case of an emergency. Subjects will take the study drug for 18 months. The study drug will be given as 2 tablets twice a day and should be taken with meals or a snack about 12 hours apart. Throughout the study, subjects will periodically undergo physical exams, blood work, and memory testing. The study partner, or caregiver, will ensure proper use of study medication as well as complete various surveys and questionnaires throughout the study.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR020359-02
Application #
7376166
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
$1,549
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
Smits, Anne; van den Anker, John N; Allegaert, Karel (2017) Clinical pharmacology of analgosedatives in neonates: ways to improve their safe and effective use. J Pharm Pharmacol 69:350-360
Newport, Elissa L; Landau, Barbara; Seydell-Greenwald, Anna et al. (2017) Revisiting Lenneberg's Hypotheses About Early Developmental Plasticity: Language Organization After Left-Hemisphere Perinatal Stroke. Biolinguistics (Nicos) 11:407-422
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
Terwilliger, Virginia K; Pratson, Lincoln; Vaughan, Christopher G et al. (2016) Additional Post-Concussion Impact Exposure May Affect Recovery in Adolescent Athletes. J Neurotrauma 33:761-5
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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