Estrogen Hormone Protocol

Alzheimer Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000177
• Other study ID #: IA0001
• Secondary ID: 3U01AG010483-08S
• Status: Completed
• Phase: Phase 3
• First received: October 29, 1999
• Last updated: December 10, 2009
• Start date: October 1995
• Est. completion date: January 1999

Study information

• Verified date: September 2009
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Estrogen is a hormone that is dominant in the female reproductive system. In women, most estrogen is produced by the ovaries. Men produce estrogen by converting testosterone into estrogen. Because this hormone also has many beneficial effects on brain cells, it currently is being studied as a treatment for Alzheimer's disease. The enzyme that forms the neurotransmitter acetylcholine is promoted in the presence of estrogen. Several very small clinical studies have demonstrated improvement in cognitive function and mood measures in women with Alzheimer's disease who take estrogen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 1999
• Est. primary completion date: January 1999
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Women with a diagnosis of Alzheimer's disease who currently are not taking estrogen replacement therapy, who have had a hysterectomy, and who are in stable general health.

Exclusion Criteria:

• Patients with an uncontrolled health problem, such as untreated high blood pressure or thyroid disease.

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Estrogen

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama, Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Rush Presbyterian St. Luke's Medical Center	Chicago	Illinois
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	University of Texas	Dallas	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Kentucky	Lexington	Kentucky
United States	University of Minnesota	Minneapolis	Minnesota
United States	Columbia Presbyterian Medical Center	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	New York University Medical Center	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California, San Diego	San Diego	California
United States	University of Washington	Seattle	Washington
United States	Southern Illinois University	Springfield	Illinois
United States	Washington University	St. Louis	Missouri
United States	University of South Florida	Tampa	Florida
United States	Burke Medical Research Institute	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mulnard RA, Cotman CW, Kawas C, van Dyck CH, Sano M, Doody R, Koss E, Pfeiffer E, Jin S, Gamst A, Grundman M, Thomas R, Thal LJ. Estrogen replacement therapy for treatment of mild to moderate Alzheimer disease: a randomized controlled trial. Alzheimer's D — View Citation

External Links

•   The Alzheimer's Disease Education and Referral (ADEAR) Center is a service of the National Institute on Aging (NIA).