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Estrogen Hormone Protocol

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Estrogen
Sponsored by
National Institute on Aging (NIA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's disease, Estrogen

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • University of Alabama, Birmingham
  • University of California, San Diego
  • Mayo Clinic Jacksonville
  • University of South Florida
  • Emory University
  • Rush Presbyterian St. Luke's Medical Center
  • Southern Illinois University
  • Indiana University Medical Center
  • University of Kansas Medical Center
  • University of Kentucky
  • Johns Hopkins University
  • Massachusetts General Hospital
  • University of Minnesota
  • Mayo Clinic
  • Washington University
  • New York University Medical Center
  • Mount Sinai School of Medicine
  • Columbia Presbyterian Medical Center
  • Burke Medical Research Institute
  • University Hospitals of Cleveland
  • University of Pennsylvania
  • University of Pittsburgh
  • University of Texas
  • Baylor College of Medicine
  • University of Washington

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 29, 1999
Last Updated
December 10, 2009
Sponsor
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000177
Brief Title
Estrogen Hormone Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
October 1995 (undefined)
Primary Completion Date
January 1999 (Actual)
Study Completion Date
January 1999 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Aging (NIA)

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer's disease, Estrogen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Estrogen

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon Thal, MD.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama, Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0017
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32225
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Rush Presbyterian St. Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Southern Illinois University
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5266
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0230
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55901-0144
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
11032
Country
United States
Facility Name
Burke Medical Research Institute
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44120
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10697060
Citation
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 Disease Cooperative Study. JAMA. 2000 Feb 23;283(8):1007-15. doi: 10.1001/jama.283.8.1007. Erratum In: JAMA 2000 Nov 22-29;284(20):2597.
Results Reference
result
Links:
URL
http://www.adcs.org/
Description
The Alzheimer's Disease Education and Referral (ADEAR) Center is a service of the National Institute on Aging (NIA).

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Estrogen Hormone Protocol

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