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Alzheimer's Disease: Therapeutic Potential of Estrogen
This study has been completed.
Study NCT00066157   Information provided by National Institute on Aging (NIA)
First Received: August 4, 2003   Last Updated: March 11, 2009   History of Changes

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

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP