Alzheimer's Disease: Therapeutic Potential of Estrogen

Alzheimer Disease Clinical Trial

Official title:

Alzheimer's Disease: Therapeutic Potential of Estrogen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00066157
• Other study ID #: 2001-477
• Secondary ID: R01AG017196-03FD
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 2001
• Est. completion date: December 2007

Study information

• Verified date: August 2018
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Transdermal estradiol
50 micrograms (low-dose) or 100 micrograms (high-dose) transdermal 17-ß-estradiol patch, changed every 3 days, for 12 months
• Medroxyprogesterone
2.5mg tablet daily for 12 months
• Placebo Patch
Transdermal placebo patch, changed every 3 days, for 12 months
• Placebo
Placebo tablet daily for 12 months

Locations

Country	Name	City	State
United States	University of Wisconsin Memory Research Program	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Skills of Independent Living: Physical functioning Performance (PFP)		Baseline and 1, 3, 6, 12, and 15 months
Secondary	Bioassays (Estradiol, estrone, medroxyprogesterone, FSH, influence of ApoE genotype in responsivity to estrogen)		Baseline and 1, 3, 6, 12, and 15 months