NCT00000177

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at below P25 for phase_3 alzheimer-disease

Timeline
Completed

Started Oct 1995

Typical duration for phase_3 alzheimer-disease

Geographic Reach
1 country

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1995

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 1999

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 29, 1999

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 1999

Completed
Last Updated

December 11, 2009

Status Verified

September 1, 2009

Enrollment Period

3.3 years

First QC Date

October 29, 1999

Last Update Submit

December 10, 2009

Conditions

Alzheimer Disease

Keywords

Alzheimer's diseaseEstrogen

Interventions

EstrogenDRUG

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

University of Alabama, Birmingham

Birmingham, Alabama, 35294-0017, United States

Location

University of California, San Diego

San Diego, California, 92093, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32225, United States

Location

University of South Florida

Tampa, Florida, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Rush Presbyterian St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

Southern Illinois University

Springfield, Illinois, 62702, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202-5266, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Kentucky

Lexington, Kentucky, 40536-0230, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55901-0144, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

New York University Medical Center

New York, New York, 10016, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Columbia Presbyterian Medical Center

New York, New York, 11032, United States

Location

Burke Medical Research Institute

White Plains, New York, 10605, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44120, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas

Dallas, Texas, 75235, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related 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 Disease Cooperative Study. JAMA. 2000 Feb 23;283(8):1007-15. doi: 10.1001/jama.283.8.1007.

    PMID: 10697060RESULT

Related Links

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Estrogens

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Leon Thal, MD.

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 29, 1999

First Posted

November 1, 1999

Study Start

October 1, 1995

Primary Completion

January 1, 1999

Study Completion

January 1, 1999

Last Updated

December 11, 2009

Record last verified: 2009-09

Locations

US(25)