Abstract

This study is designed 1) to evaluate the efficacy of MK-0966 25 mg compared to placebo for the prevention of Alzheimer's disease in patients with Mild Cognitive Impairment and 2) to evaluate the overall safety and tolerability of MK-0966 25 mg compared to placebo in patients with Mild Cognitive Impairment. This is a two year placebo-controlled, parallel-groups, double-blind, multicenter study (with in-house blinding), to evaluate the effects of MK-0966 25mg on the prevention of Alzheimer's disease and cognitive decline in approximately 1300 patients > and = to 65 years of age with Mild Cognitive Impairment. After completing the screening visit, all patients who qualify for the study will be randomized to placebo, or 25 mg MK-0966 given orally once a day for 20 months. The primary data analysis will compare the cumulative incidence of clinical AD between MK-0966 25 mg and placebo groups using the appropriate survival methods such as Cox proportional regressions. Safety will be evaluated by tabulation of adverse experiences and laboratory abnormalities.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR000645-29
Application #
6307081
Study Section
Project Start
1999-12-01
Project End
2000-11-30
Budget Start
Budget End
Support Year
29
Fiscal Year
2000
Total Cost
Indirect Cost

  Institution

Name
Columbia University (N.Y.)
Department
Type
DUNS #
167204994
City
New York
State
NY
Country
United States
Zip Code
10032

  Publications

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Widen, Elizabeth M; Whyatt, Robin M; Hoepner, Lori A et al. (2016) Gestational weight gain and obesity, adiposity and body size in African-American and Dominican children in the Bronx and Northern Manhattan. Matern Child Nutr 12:918-28
Maresca, Michelle M; Hoepner, Lori A; Hassoun, Abeer et al. (2016) Prenatal Exposure to Phthalates and Childhood Body Size in an Urban Cohort. Environ Health Perspect 124:514-20
Tooley, James E; Vudattu, Nalini; Choi, Jinmyung et al. (2016) Changes in T-cell subsets identify responders to FcR-nonbinding anti-CD3 mAb (teplizumab) in patients with type 1 diabetes. Eur J Immunol 46:230-41
Melhem, Nadine M; Keilp, John G; Porta, Giovanna et al. (2016) Blunted HPA Axis Activity in Suicide Attempters Compared to those at High Risk for Suicidal Behavior. Neuropsychopharmacology 41:1447-56
Dong, Chuanhui; Della-Morte, David; Rundek, Tatjana et al. (2016) Evidence to Maintain the Systolic Blood Pressure Treatment Threshold at 140 mm?Hg for Stroke Prevention: The Northern Manhattan Study. Hypertension 67:520-6
Buckley, Jessie P; Engel, Stephanie M; Braun, Joseph M et al. (2016) Prenatal Phthalate Exposures and Body Mass Index Among 4- to 7-Year-old Children: A Pooled Analysis. Epidemiology 27:449-58
Leung, Vivien; Chiu, Ya-Lin; Kotler, Donald P et al. (2016) Effect of Recombinant Human Growth Hormone and Rosiglitazone for HIV-Associated Abdominal Fat Accumulation on Adiponectin and other Markers of Inflammation. HIV Clin Trials 17:55-62
Branis, Natalia M; Etesami, Marjan; Walker, Ryan W et al. (2015) Effect of a 1-week, eucaloric, moderately high-fat diet on peripheral insulin sensitivity in healthy premenopausal women. BMJ Open Diabetes Res Care 3:e000100

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