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Home > "A" Clinical Trials Conditions > Alzheimer's Disease: Therapeutic Potential of Estrogen  Alzheimer's Disease: Therapeutic Potential of Estrogen
Alzheimer's Disease: Therapeutic Potential of Estrogen
For Condition: Alzheimer Disease
Status: Recruiting
Sponsor(s): National Institute on Aging (NIA) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 55 Years/90 Years
Genders: Female
Protocol Entry Criteria: Inclusion: - 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: - 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.
Total Enrollment: 160
Location and Contact Information:
Overall Study Official:
SanjayAsthana, Principal Investigator, University of Wisconsin - Madison, William S. Middleton VA Hospital
University of Wisconsin Memory Research Program *Recruiting*
Madison, Wisconsin, 53705
United States
Recruiting Memory Program Study 866-636-7764
Additional Information:
Study ID Numbers: IA0048; NIH grant AG17196-03,FDA IRB approval M1285
Study Start Date: September 2001
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066157
Other Alzheimer Disease Studies:
1. Insulin, Neurogentics and Memory in Alzheimer's Disease
2. Alzheimer's Disease Genetics Study
3. A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study).
4. Agitation in Alzheimer's Disease
5. Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE)
Related Studies:
Other Alzheimer Disease Clinical Trials
Other Wisconsin Clinical Trials
Other Madison Clinical Trials
Alzheimer's Disease: Therapeutic Potential of Estrogen
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