MedDataX Logo

Estrogen Hormone Protocol

NCT ID: NCT00000177

Last Updated: 2009-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-10-31

Study Completion Date

1999-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Alzheimer's disease Estrogen

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Estrogen

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Aging (NIA)

NIH

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Leon Thal, MD.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alabama, Birmingham

Birmingham, Alabama, United States

Site Status

University of California, San Diego

San Diego, California, United States

Site Status

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Rush Presbyterian St. Luke's Medical Center

Chicago, Illinois, United States

Site Status

Southern Illinois University

Springfield, Illinois, United States

Site Status

Indiana University Medical Center

Indianapolis, Indiana, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

University of Kentucky

Lexington, Kentucky, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

New York University Medical Center

New York, New York, United States

Site Status

Mount Sinai School of Medicine

New York, New York, United States

Site Status

Columbia Presbyterian Medical Center

New York, New York, United States

Site Status

Burke Medical Research Institute

White Plains, New York, United States

Site Status

University Hospitals of Cleveland

Cleveland, Ohio, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

University of Texas

Dallas, Texas, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 10697060 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.adcs.org/

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3U01AG010483-08S2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IA0001

Identifier Type: -

Identifier Source: org_study_id