Alzheimer's Disease: Therapeutic Potential of Estrogen

University of Wisconsin (UW)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Alzheimer Disease

Treatments: Drug: Placebo; Drug: Medroxyprogesterone; Drug: Placebo Patch; Drug: Transdermal estradiol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00066157

2001-477

R01AG017196-03 (U.S. NIH Grant/Contract)

NIH grant AG17196-03

IA0048 (Other Identifier)

FDA IRB approval M1285

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 42 patients

Sex: Female

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

estradiol patch and medroxyprogesterone

Treatment:

Drug: Transdermal estradiol

Drug: Medroxyprogesterone

2

Active Comparator group

Description:

estradiol patch and placebo pill

Treatment:

Drug: Transdermal estradiol

Drug: Placebo

3

Active Comparator group

Description:

placebo patch and medroxyprogesterone

Treatment:

Drug: Placebo Patch

Drug: Medroxyprogesterone

4

Placebo Comparator group

Description:

placebo patch and placebo pill

Treatment:

Drug: Placebo

Drug: Placebo Patch