Alzheimer DiseasePhase 3NCT00000177
Estrogen Hormone Protocol
A Phase 3 study testing Estrogen in people with Alzheimer Disease, run by National Institute on Aging (NIA) at 25 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Estrogen
- How many people
- 120 participants
- Where
- 25 sitesUnited States
- Study dates
- Oct 1995to Jan 1999
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with an uncontrolled health problem, such as untreated high blood pressure or thyroid disease.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Emory University
Atlanta, Georgia, 30329
Johns Hopkins University
Baltimore, Maryland, 21224
University of Alabama, Birmingham
Birmingham, Alabama, 35294-0017
Massachusetts General Hospital
Boston, Massachusetts, 02114
Rush Presbyterian St. Luke's Medical Center
Chicago, Illinois, 60612
University Hospitals of Cleveland
Cleveland, Ohio, 44120
University of Texas
Dallas, Texas, 75235
Baylor College of Medicine
Houston, Texas, 77030
Indiana University Medical Center
Indianapolis, Indiana, 46202-5266
Mayo Clinic Jacksonville
Jacksonville, Florida, 32225
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Kentucky
Lexington, Kentucky, 40536-0230
University of Minnesota
Minneapolis, Minnesota, 55455
New York University Medical Center
New York, New York, 10016
Mount Sinai School of Medicine
New York, New York, 10029
Columbia Presbyterian Medical Center
New York, New York, 11032
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55901-0144
University of California, San Diego
San Diego, California, 92093
University of Washington
Seattle, Washington, 98195
Southern Illinois University
Springfield, Illinois, 62702
Washington University
St Louis, Missouri, 63110
University of South Florida
Tampa, Florida
Burke Medical Research Institute
White Plains, New York, 10605
About this study
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.
- Conditions
- Alzheimer Disease
- Being tested
- Estrogen
- Keywords
- Alzheimer's disease, Estrogen
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstrogenDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 1999 (estimated)
- Study startOct 1995
- Primary completionJan 1999
- Study completionJan 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Leon Thal, MD., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000177
- Sponsor's protocol ID
- IA0001
- Other IDs
- 3U01AG010483-08S2
- Status last verified
- Sep 2009
- First submitted
- 29 Oct 1999
- Last updated
- 11 Dec 2009
- Results posted
- No
Publications
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.
PubMed 10697060
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estrogen Hormone Protocol
- ClinicalTrials.gov ID
- NCT00000177
- Acronym / sponsor ID
- IA0001
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's disease, Estrogen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Oct 1995
- Primary completion
- Jan 1999 (actual)
- Study completion
- Jan 1999 (actual)
- First posted
- 1 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with an uncontrolled health problem, such as untreated high blood pressure or thyroid disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estrogen | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2009.
- Results publication: PubMed 10697060Mulnard 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.
- The Alzheimer's Disease Education and Referral (ADEAR) Center is a service of the National Institute on Aging (NIA).Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leon Thal, MD. principal investigator
University of California, San Diego
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Estrogen in people with Alzheimer Disease, run by National Institute on Aging (NIA) at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000177, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2009.