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Completed

NCT Number: NCT00066157

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.

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Key information

Age range

55 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Wisconsin Memory Research Program

Madison, Wisconsin, 53705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transdermal Estradiol

Drug

50 micrograms (low-dose) or 100 micrograms (high-dose) transdermal 17-ß-estradiol patch, changed every 3 days, for 12 months

Other names: 17 (beta) estradiol transdermal patch, Estrogen replacement therapy

medroxyprogesterone

Drug

2.5mg tablet daily for 12 months

Other names: progesterone

Placebo Patch

Drug

Transdermal placebo patch, changed every 3 days, for 12 months

Placebo

Drug

Placebo tablet daily for 12 months

Primary outcomes

  1. 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

Secondary outcomes

  1. Skills of Independent Living: Physical functioning Performance (PFP)

    Time frame: Baseline and 1, 3, 6, 12, and 15 months

  2. Bioassays (Estradiol, estrone, medroxyprogesterone, FSH, influence of ApoE genotype in responsivity to estrogen)

    Time frame: Baseline and 1, 3, 6, 12, and 15 months

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Aug 5, 2003
Registry last updated
Aug 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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