Alzheimer's Disease: Therapeutic Potential of Estrogen

Phase 2

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: Transdermal estradiol; Drug: Medroxyprogesterone; Drug: Placebo; Drug: Placebo Patch

• Registration Number: NCT00066157
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2001-09
• Study First Submitted: 2003-08-04
• Study First Submitted QC: 2003-08-04
• Study First Posted: 2003-08-05
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Medroxyprogesterone	estradiol patch and medroxyprogesterone
2	Transdermal estradiol	estradiol patch and placebo pill
1	Transdermal estradiol	estradiol patch and medroxyprogesterone
4	Placebo	placebo patch and placebo pill
3	Medroxyprogesterone	placebo patch and medroxyprogesterone
3	Placebo Patch	placebo patch and medroxyprogesterone
2	Placebo	estradiol patch and placebo pill
4	Placebo Patch	placebo patch and placebo pill

Primary Outcome Measures

Name	Time	Method
Cognition: delayed recall on Buschke Selective Reminding Test; Stroop Interference condition--completion time and errors; Clinician-rated Interview Based Impression of Change	Baseline and 1, 3, 6, 12, and 15 months

Secondary Outcome Measures

Name	Time	Method
Skills of Independent Living: Physical functioning Performance (PFP)	Baseline and 1, 3, 6, 12, and 15 months
Bioassays (Estradiol, estrone, medroxyprogesterone, FSH, influence of ApoE genotype in responsivity to estrogen)	Baseline and 1, 3, 6, 12, and 15 months

Trial Locations

Locations (1)

University of Wisconsin Memory Research Program; 🇺🇸 Madison, Wisconsin, United States