Alzheimer's Disease: Therapeutic Potential of Estrogen



Status:Completed
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:55 - 90
Updated:8/25/2018
Start Date:September 2001
End Date:December 2007

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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.

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.

Inclusion Criteria:

- Postmenopausal women with Alzheimer's disease and without other dementias (diagnosed
by study staff or from an outside clinic)

- Mini Mental State Examination score greater than 15/30

Exclusion Criteria:

- History of cancer of reproductive tissues

- History of deep vein thrombosis or blot clots

- Diabetes

- Heart disease or stroke

- Liver problems including hepatitis

- Severe vision or hearing problems

- Tobacco use

- Lack of an adequate caregiver

- inability to perform psychometric testing
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Madison, WI
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