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| Sponsor: | National Institute on Aging (NIA) |
|---|---|
| Information provided by: | National Institute on Aging (NIA) |
| ClinicalTrials.gov Identifier: | NCT00066157 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease |
Drug: Transdermal estradiol Drug: Medroxyprogesterone Drug: Placebo Patch Drug: Placebo |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Alzheimer's Disease: Therapeutic Potential of Estrogen |
| Enrollment: | 42 |
| Study Start Date: | September 2001 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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
Drug: Medroxyprogesterone
2.5mg tablet daily for 12 months
|
|
2: Active Comparator
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
Drug: Placebo
Placebo tablet daily for 12 months
|
|
3: Active Comparator
placebo patch and medroxyprogesterone
|
Drug: Medroxyprogesterone
2.5mg tablet daily for 12 months
Drug: Placebo Patch
Transdermal placebo patch, changed every 3 days, for 12 months
|
|
4: Placebo Comparator
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
|
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| Ages Eligible for Study: | 55 Years to 90 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Wisconsin | |
| University of Wisconsin Memory Research Program | |
| Madison, Wisconsin, United States, 53705 | |
| Principal Investigator: | Sanjay Asthana, MD | University of Wisconsin - Madison, William S. Middleton VA Hospital |
More Information
| Responsible Party: | University of Wisconsin-Madison Medical School ( Sanjay Asthana, MD, FRCP(C) ) |
| Study ID Numbers: | IA0048, FDA IRB approval M1285, NIH grant AG17196-03 |
| Study First Received: | August 4, 2003 |
| Last Updated: | March 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00066157 History of Changes |
| Health Authority: | United States: Federal Government |
|
Alzheimer disease Hormone replacement therapy Postmenopausal women |
|
Medroxyprogesterone 17-Acetate Antineoplastic Agents Contraceptive Agents Contraceptives, Oral Estradiol valerate Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Estradiol 17 beta-cypionate Reproductive Control Agents Contraceptive Agents, Male Neurodegenerative Diseases Brain Diseases Hormones Mental Disorders |
Estradiol 3-benzoate Therapeutic Uses Contraceptives, Oral, Synthetic Polyestradiol phosphate Dementia Estrogens Antineoplastic Agents, Hormonal Nervous System Diseases Alzheimer Disease Central Nervous System Diseases Estradiol Pharmacologic Actions Delirium, Dementia, Amnestic, Cognitive Disorders Medroxyprogesterone Tauopathies |