| August 4, 2003 |
| March 11, 2009 |
| September 2001 |
| January 2008 (final data collection date for primary outcome measure) |
| 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 ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00066157 on ClinicalTrials.gov Archive Site |
- Skills of Independent Living: Physical functioning Performance (PFP) [ Time Frame: Baseline and 1, 3, 6, 12, and 15 months ] [ Designated as safety issue: No ]
- Bioassays (Estradiol, estrone, medroxyprogesterone, FSH, influence of ApoE genotype in responsivity to estrogen) [ Time Frame: Baseline and 1, 3, 6, 12, and 15 months ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Alzheimer's Disease: Therapeutic Potential of Estrogen |
| 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. |
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. |
| Phase II, Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Alzheimer Disease |
- Drug: Transdermal estradiol
- Drug: Medroxyprogesterone
- Drug: Placebo Patch
- Drug: Placebo
|
- Experimental: estradiol patch and medroxyprogesterone
- Active Comparator: estradiol patch and placebo pill
- Active Comparator: placebo patch and medroxyprogesterone
- Placebo Comparator: placebo patch and placebo pill
|
- Cholerton B, Gleason CE, Baker LD, Asthana S. Estrogen and Alzheimer's disease: the story so far. Drugs Aging. 2002;19(6):405-27. Review.
- Asthana S, Baker LD, Craft S, Stanczyk FZ, Veith RC, Raskind MA, Plymate SR. High-dose estradiol improves cognition for women with AD: results of a randomized study. Neurology. 2001 Aug 28;57(4):605-12.
- Asthana S, Craft S, Baker LD, Raskind MA, Birnbaum RS, Lofgreen CP, Veith RC, Plymate SR. Cognitive and neuroendocrine response to transdermal estrogen in postmenopausal women with Alzheimer's disease: results of a placebo-controlled, double-blind, pilot study. Psychoneuroendocrinology. 1999 Aug;24(6):657-77.
|
| |
| Completed |
| 42 |
| January 2008 |
| January 2008 (final data collection date for primary outcome measure) |
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
|
| Female |
| 55 Years to 90 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00066157 |
| Sanjay Asthana, MD, FRCP(C), University of Wisconsin-Madison Medical School |
| IA0048, FDA IRB approval M1285, NIH grant AG17196-03 |
| National Institute on Aging (NIA) |
|
| Principal Investigator: |
Sanjay Asthana, MD |
University of Wisconsin - Madison, William S. Middleton VA Hospital |
|
|
| National Institute on Aging (NIA) |
| July 2008 |