University of Wisconsin Memory Research Program
Madison, Wisconsin, 53705, United States
NCT Number: NCT00066157
This is a 15-month study to determine the effectiveness of hormone replacement therapy in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease.
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Notify Me55 year–90 year
Female
Interventional
Phase 2 / Phase 3
Madison, Wisconsin, 53705, United States
Estrogen is a naturally occurring hormone produced in a woman's body. The purpose of this 15-month study is to determine the effectiveness of hormone replacement therapy in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease and without other dementias.
Patients who volunteer for this study will either receive a patch containing 17-ß-estradiol or will receive an inactive placebo patch. In addition, patients will be given either medroxyprogesterone or an inactive placebo pill. Neither the volunteers nor the study staff will know which type of patch or pill a patient receives. Patients must be generally healthy and have mild-to-moderate dementia. There must be a patient caregiver who can watch for side effects and ensure that the patient takes the study medications on schedule. Patients will undergo neuropsychological tests and an evaluation of the ability to live independently at each visit as well as laboratory evaluations, such as the taking of blood. Each visit will last approximately 3 hours. A total of 160 participants are being recruited.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
50 micrograms (low-dose) or 100 micrograms (high-dose) transdermal 17-ß-estradiol patch, changed every 3 days, for 12 months
Other names: 17 (beta) estradiol transdermal patch, Estrogen replacement therapy
2.5mg tablet daily for 12 months
Other names: progesterone
Transdermal placebo patch, changed every 3 days, for 12 months
Placebo tablet daily for 12 months
Time frame: Baseline and 1, 3, 6, 12, and 15 months
Time frame: Baseline and 1, 3, 6, 12, and 15 months
Time frame: Baseline and 1, 3, 6, 12, and 15 months
University of Wisconsin, Madison
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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