The goal of this trial is to determine whether or not estrogen replacement therapy shows promise in improving the cognitive, affective and/or physiological function of postmenopausal, hysterectomized females with Alzheimer's disease (AD). Previous reports have suggested that postmenopausal women experience benefits including but not limited to improvement in mood, concentration and memory from estrogen replacement therapy (Sherwin, 1988). It has also been suggested that a subset of demented women on estrogen replacemenet therapy experience benefit in the form of improvements in selected areas of cognitive performance (Fillit, et al., 1986; Honjo, et al., 1989). This study is a double-blind placebo-controlled pilot study of two doses of estrogen versus placebo in hysterectomized women over the age of 60. Forty subjects will be enrolled in each cell. The study is 15 months in length with 12 months of exposure to drug/placebo followed by a 3 month single-blind wash-out period. Outcome measures include: global measures, measurement of memory, affect, motor performance, attention, language, functional ability, and quality of life. Recruitment for this study is completed at this center. This study is part of a multicenter clinical trial and final data analysis has not been performed.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR001066-22S3
Application #
6220147
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
22
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Massachusetts General Hospital
Department
Type
DUNS #
City
Boston
State
MA
Country
United States
Zip Code
02199
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