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Alzheimer's Disease: Therapeutic Potential of Estrogen

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ClinicalTrials.gov Identifier: NCT00066157
Recruitment Status : Completed
First Posted : August 5, 2003
Last Update Posted : October 5, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Transdermal estradiol Drug: Medroxyprogesterone Drug: Placebo Patch Drug: Placebo Phase 2 Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Alzheimer's Disease: Therapeutic Potential of Estrogen
Study Start Date : September 2001
Primary Completion Date : January 2008
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Estradiol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
estradiol patch and medroxyprogesterone
Drug: Transdermal estradiol
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
Drug: Medroxyprogesterone
2.5mg tablet daily for 12 months
Other Name: progesterone
Active Comparator: 2
estradiol patch and placebo pill
Drug: Transdermal estradiol
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
Drug: Placebo
Placebo tablet daily for 12 months
Active Comparator: 3
placebo patch and medroxyprogesterone
Drug: Medroxyprogesterone
2.5mg tablet daily for 12 months
Other Name: progesterone
Drug: Placebo Patch
Transdermal placebo patch, changed every 3 days, for 12 months
Placebo Comparator: 4
placebo patch and placebo pill
Drug: Placebo Patch
Transdermal placebo patch, changed every 3 days, for 12 months
Drug: Placebo
Placebo tablet daily for 12 months


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066157


Locations
United States, Wisconsin
University of Wisconsin Memory Research Program
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute on Aging (NIA)
Investigators
Principal Investigator: Sanjay Asthana, MD University of Wisconsin - Madison, William S. Middleton VA Hospital
More Information

Publications:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00066157     History of Changes
Other Study ID Numbers: IA0048
R01AG017196-03 ( U.S. NIH Grant/Contract )
FDA IRB approval M1285
NIH grant AG17196-03
First Posted: August 5, 2003    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: September 2010

Keywords provided by University of Wisconsin, Madison:
Alzheimer disease
Hormone replacement therapy
Postmenopausal women

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Estradiol
Polyestradiol phosphate
Estrogens
Progesterone
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Medroxyprogesterone
Medroxyprogesterone Acetate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Progestins
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents