Official Title: “Alzheimer's Disease: Therapeutic Potential of Estrogen”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: January 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Transdermal estradiol
  • 50 micrograms (low-dose) or 100 micrograms (high-dose) transdermal 17-ß-estradiol patch, changed every 3 days, for 12 months
• Drug: Medroxyprogesterone
  • 2.5mg tablet daily for 12 months
• Drug: Placebo Patch
  • Transdermal placebo patch, changed every 3 days, for 12 months
• Drug: Placebo
  • Placebo tablet daily for 12 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • estradiol patch and medroxyprogesterone
• Active Comparator: 2
  • estradiol patch and placebo pill
• Active Comparator: 3
  • placebo patch and medroxyprogesterone
• Placebo Comparator: 4
  • placebo patch and placebo pill

Primary Measures

• Cognition: delayed recall on Buschke Selective Reminding Test; Stroop Interference condition--completion time and errors; Clinician-rated Interview Based Impression of Change
  • Time Frame: Baseline and 1, 3, 6, 12, and 15 months
    Safety Issue?: No

Secondary Measures

• Skills of Independent Living: Physical functioning Performance (PFP)
  • Time Frame: Baseline and 1, 3, 6, 12, and 15 months
    Safety Issue?: No
• Bioassays (Estradiol, estrone, medroxyprogesterone, FSH, influence of ApoE genotype in responsivity to estrogen)
  • Time Frame: Baseline and 1, 3, 6, 12, and 15 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Aging (NIA)

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00066157

Study ID Number: IA0048

ClinicalTrials.gov Identifier: NCT00066157

Health Authority: United States: Federal Government

University of Wisconsin Memory Research Program