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.

Condition	Treatment or Intervention	Phase
Alzheimer Disease	Drug: Transdermal 17-ß-estradiol  Drug: Medroxyprogesterone	Phase II Phase III

Further Study Details: 

Expected Total Enrollment:  160

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.

Ages Eligible for Study:  55 Years   -   90 Years,  Genders Eligible for Study:  Female

Criteria

Inclusion:

• 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:

• 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.

Memory Research Program Study Coordinator      1-866-636-7764    memory-research@medicine.wisc.edu
Memory Research Program Study Coordinator      608-263-2582    memory-research@medicine.wisc.edu

Wisconsin
      University of Wisconsin Memory Research Program, Madison,  Wisconsin,  53705,  United States; Recruiting

Study chairs or principal investigators

Sanjay Asthana, MD,  Principal Investigator,  University of Wisconsin - Madison, William S. Middleton VA Hospital   

Study ID Numbers:  IA0048; FDA IRB approval M1285; NIH grant AG17196-03
Record last reviewed:  October 2004
Last Updated:  October 22, 2004
Record first received:  August 4, 2003
ClinicalTrials.gov Identifier:  NCT00066157
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08