Clinical trial NCT00066157: Alzheimer's Disease: Therapeutic Potential of Estrogen
Official title: Alzheimer's Disease: Therapeutic Potential of Estrogen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Alzheimer Disease
Keywords: Alzheimer disease
Hormone replacement therapy
Postmenopausal women
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2003-08-05
Enrollment: 42
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cognition: delayed recall on Buschke Selective Reminding Test; Stroop Interference condition--completion time and errors; Clinician-rated Interview Based Impression of Change
timeFrame: Baseline and 1, 3, 6, 12, and 15 months
Secondary outcomes:
measure: Skills of Independent Living: Physical functioning Performance (PFP)
timeFrame: Baseline and 1, 3, 6, 12, and 15 months
measure: Bioassays (Estradiol, estrone, medroxyprogesterone, FSH, influence of ApoE genotype in responsivity to estrogen)
timeFrame: Baseline and 1, 3, 6, 12, and 15 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Memory Research Program
state: Wisconsin
Study officials:
affiliation: University of Wisconsin - Madison, William S. Middleton VA Hospital
name: Sanjay Asthana, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cholerton B, Gleason CE, Baker LD, Asthana S. Estrogen and Alzheimer's disease: the story so far. Drugs Aging. 2002;19(6):405-27. doi: 10.2165/00002512-200219060-00002.
citation: 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. doi: 10.1212/wnl.57.4.605.
citation: 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. doi: 10.1016/s0306-4530(99)00020-7.