Alzheimer Disease
Conditions
Keywords
Alzheimer disease, Hormone replacement therapy, Postmenopausal women
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.
Interventions
50 micrograms (low-dose) or 100 micrograms (high-dose) transdermal 17-ß-estradiol patch, changed every 3 days, for 12 months
2.5mg tablet daily for 12 months
DRUGPlacebo Patch
Transdermal placebo patch, changed every 3 days, for 12 months
DRUGPlacebo
Placebo tablet daily for 12 months
Sponsors
National Institute on Aging (NIA)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 90 Years
Healthy volunteers
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed