Alzheimer DiseasePhase 3NCT00000176
Alzheimer's Disease Prevention Trial
A Phase 3 study testing Estrogen and Estrogen and Progesterone in people with Alzheimer Disease and Memory Disorders, run by National Institute on Aging (NIA) at 22 sites in United States.
Trial summary
This is a three-year study to determine if estrogens can prevent memory loss and Alzheimer's disease in women with a family history of Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Memory Disorders
- What is being tested?
- Estrogen and Estrogen and Progesterone
- How many people
- Not given
- Where
- 22 sitesUnited States
- Study dates
- Start not givento Sep 2007
- 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 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy women 65 or older with a family history of memory problems not currently on estrogen.
Who cannot join
- Significant neurological impairment
- Current estrogen use
- History of breast cancer
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
University of Alabama
Birmingham, Alabama, 35294
Duke University Medical Center
Durham, North Carolina, 27710
Lee Memorial Health System
Fort Myers, Florida, 33901
University of California, Irvine
Irvine, California, 29697-4540
Mayo Clinic Jacksonville
Jacksonville, Florida, 32225
Wein Center
Miami Beach, Florida, 33140
Columbia University
New York, New York, 10032
Cornell Medical Center, New York Presbyterian Medical Center
New York, New York
Eastern Virginia Medical School
Norfolk, Virginia, 23507-1912
Medical University of South Carolina
North Charleston, South Carolina, 29406
West Florida Regional Medical Center
Pensacola, Florida, 32514
North Broward Medical Center
Pompano Beach, Florida
New York United Hospital Medical Center
Port Chester, New York, 10573
Butler Hospital, Rhode Island Hospital
Providence, Rhode Island, 02906
Neurology Group of Bergen County
Ridgewood, New Jersey, 07450
New England Center for Headache
Stamford, Connecticut, 06902-1249
Tallahassee Memorial Health Center
Tallahassee, Florida, 32308
Clinical Pharmaceutical Trials
Tulsa, Oklahoma, 74104-5428
Howard University
Washington D.C., District of Columbia, 20060
St. Mary's Medical Center
West Palm Beach, Florida, 33407
Burke Medical Research Institute
White Plains, New York, 10605
About this study
Official title: Alzheimer's Disease Prevention Trial. A Multi-center, Randomized, Double-blind Placebo Controlled Trial of Estrogens to Prevent Alzheimer's Disease and Loss of Memory in Women.
This is a three-year study to determine if estrogens can prevent memory loss and Alzheimer's disease in women with a family history of Alzheimer's disease.
Read the detailed description
PREventing Postmenopausal memory loss and Alzheimer's with Replacement Estrogens (PREPARE) is a double-blind-placebo controlled trial to determine whether estrogen (or estrogen and progesterone) can delay the onset of memory loss or Alzheimer's Disease in elderly women with a family history of the disease.
- Conditions
- Alzheimer Disease, Memory Disorders
- Being tested
- Estrogen, Estrogen and Progesterone
- Keywords
- Alzheimer's disease, memory loss, Estrogen
- Medical subject headings
- Alzheimer Disease, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstrogenDrug
Estrogen and ProgesteroneDrug
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)
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Mary Sano, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000176
- Sponsor's protocol ID
- IA0018
- Other IDs
- RO 1AG15922-01
- Status last verified
- Nov 2010
- First submitted
- 29 Oct 1999
- Last updated
- 5 Nov 2010
- Results posted
- No
Publications
Tang MX, Jacobs D, Stern Y, Marder K, Schofield P, Gurland B, Andrews H, Mayeux R. Effect of oestrogen during menopause on risk and age at onset of Alzheimer's disease. Lancet. 1996 Aug 17;348(9025):429-32. doi: 10.1016/S0140-6736(96)03356-9.
PubMed 8709781Kawas C, Resnick S, Morrison A, Brookmeyer R, Corrada M, Zonderman A, Bacal C, Lingle DD, Metter E. A prospective study of estrogen replacement therapy and the risk of developing Alzheimer's disease: the Baltimore Longitudinal Study of Aging. Neurology. 1997 Jun;48(6):1517-21. doi: 10.1212/wnl.48.6.1517.
PubMed 9191758Jacobs DM, Tang MX, Stern Y, Sano M, Marder K, Bell KL, Schofield P, Dooneief G, Gurland B, Mayeux R. Cognitive function in nondemented older women who took estrogen after menopause. Neurology. 1998 Feb;50(2):368-73. doi: 10.1212/wnl.50.2.368.
PubMed 9484355Aloysi A, Van Dyk K, Sano M. Women's cognitive and affective health and neuropsychiatry. Mt Sinai J Med. 2006 Nov;73(7):967-75.
PubMed 17195882
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alzheimer's Disease Prevention Trial. A Multi-center, Randomized, Double-blind Placebo Controlled Trial of Estrogens to Prevent Alzheimer's Disease and Loss of Memory in Women.
- ClinicalTrials.gov ID
- NCT00000176
- Acronym / sponsor ID
- IA0018
- Conditions
- Alzheimer Disease, Memory Disorders
- Keywords
- Alzheimer's disease, memory loss, Estrogen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (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.
This is a three-year study to determine if estrogens can prevent memory loss and Alzheimer's disease in women with a family history of Alzheimer's disease.
Detailed description
PREventing Postmenopausal memory loss and Alzheimer's with Replacement Estrogens (PREPARE) is a double-blind-placebo controlled trial to determine whether estrogen (or estrogen and progesterone) can delay the onset of memory loss or Alzheimer's Disease in elderly women with a family history of the disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Healthy women 65 or older with a family history of memory problems not currently on estrogen.
Key exclusion criteria (3 listed)
- Significant neurological impairment
- Current estrogen use
- History of breast cancer
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 | – |
| Estrogen and Progesterone | 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 5 Nov 2010.
- Background: PubMed 8709781Tang MX, Jacobs D, Stern Y, Marder K, Schofield P, Gurland B, Andrews H, Mayeux R. Effect of oestrogen during menopause on risk and age at onset of Alzheimer's disease. Lancet. 1996 Aug 17;348(9025):429-32. doi: 10.1016/S0140-6736(96)03356-9.
- Background: PubMed 9191758Kawas C, Resnick S, Morrison A, Brookmeyer R, Corrada M, Zonderman A, Bacal C, Lingle DD, Metter E. A prospective study of estrogen replacement therapy and the risk of developing Alzheimer's disease: the Baltimore Longitudinal Study of Aging. Neurology. 1997 Jun;48(6):1517-21. doi: 10.1212/wnl.48.6.1517.
- Background: PubMed 9484355Jacobs DM, Tang MX, Stern Y, Sano M, Marder K, Bell KL, Schofield P, Dooneief G, Gurland B, Mayeux R. Cognitive function in nondemented older women who took estrogen after menopause. Neurology. 1998 Feb;50(2):368-73. doi: 10.1212/wnl.50.2.368.
- Results publication: PubMed 17195882Aloysi A, Van Dyk K, Sano M. Women's cognitive and affective health and neuropsychiatry. Mt Sinai J Med. 2006 Nov;73(7):967-75.
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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.
Mary Sano, PhD principal investigator
Icahn School of Medicine at Mount Sinai
22 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 and Estrogen and Progesterone in people with Alzheimer Disease and Memory Disorders, run by National Institute on Aging (NIA) at 22 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 3 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 5 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 NCT00000176, which also lists 4 linked publications.
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 5 Nov 2010.