Estrogen Hormone Protocol

Sponsor

National Institute on Aging (NIA) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000177

Collaborator

(none)

120

Enrollment

Locations

Duration (Months)

4.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Drug: Estrogen	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Masking:

Double

Primary Purpose:

Treatment

Study Start Date :

Oct 1, 1995

Actual Primary Completion Date :

Jan 1, 1999

Actual Study Completion Date :

Jan 1, 1999

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama, Birmingham	Birmingham	Alabama	United States	35294-0017
2	University of California, San Diego	San Diego	California	United States	92093
3	Mayo Clinic Jacksonville	Jacksonville	Florida	United States	32225
4	University of South Florida	Tampa	Florida	United States
5	Emory University	Atlanta	Georgia	United States	30329
6	Rush Presbyterian St. Luke's Medical Center	Chicago	Illinois	United States	60612
7	Southern Illinois University	Springfield	Illinois	United States	62702
8	Indiana University Medical Center	Indianapolis	Indiana	United States	46202-5266
9	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
10	University of Kentucky	Lexington	Kentucky	United States	40536-0230
11	Johns Hopkins University	Baltimore	Maryland	United States	21224
12	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
13	University of Minnesota	Minneapolis	Minnesota	United States	55455
14	Mayo Clinic	Rochester	Minnesota	United States	55901-0144
15	Washington University	St. Louis	Missouri	United States	63110
16	New York University Medical Center	New York	New York	United States	10016
17	Mount Sinai School of Medicine	New York	New York	United States	10029
18	Columbia Presbyterian Medical Center	New York	New York	United States	11032
19	Burke Medical Research Institute	White Plains	New York	United States	10605
20	University Hospitals of Cleveland	Cleveland	Ohio	United States	44120
21	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
22	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
23	University of Texas	Dallas	Texas	United States	75235
24	Baylor College of Medicine	Houston	Texas	United States	77030
25	University of Washington	Seattle	Washington	United States	98195