AgingNCT00097058
Estrogen Use in Protection From Cognitive Decline
An observational study of Aging and Menopause, run by Stanford University at 1 site in United States.
Trial summary
This study is designed to assess the effects of estrogen therapy among postmenopausal women at risk for cognitive decline. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Nov 2014
- Phase
- Observational
- 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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women between the ages of 45 and 65 years of age, currently on estrogen therapy for 1 year prior to enrollment in study, and at risk for cognitive decline.
Who may be able to join
- Women between the ages of 45 and 65
- Currently on hormone replacement
- One year or more post complete cessation of menses
- Willing to sign the Human Subject Protection Consent form prior to enrollment in the study
- Willing to be randomized to continue or discontinue estrogen therapy
- Adequately visually and auditorially acute to allow neuropsychological testing
Show all 9Show fewer
- Beyond 8 years of educational achievement to allow adequate neuropsychological testing
- Willing to undergo brain imaging
- At risk for cognitive decline, as defined by one or more of the following: Personal or family history of mood disorder, Hypothyroidism, Diabetes, Family history of Alzheimer's, APOE-4 allele
Who cannot join
- Diagnosis of possible or probable Alzheimer's disease or dementia
- Cerebrovascular disease or uncontrolled hypertension (systolic BP >170 or diastolic BP >100)
- History of myocardial infarction within previous year or unstable heart disease
- History of significant liver disease, pulmonary disease, or current cancer
- Contraindication for MRI (metal in body, claustrophobia, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine, Dept. of Psychiatry and Behavioral Sciences
Stanford, California, 94070-5723
About this study
This study is designed to assess the effects of estrogen therapy among postmenopausal women at risk for cognitive decline.
Read the detailed description
A total of 71 postmenopausal women ages 50-65 on estrogen therapy will be randomized to continue or discontinue use of estrogen and will be followed for two years.
Participants will undergo PET and MRI scans and neuropsychological assessments initially and at the end of the two-year follow-up period. These procedures will allow us to evaluate brain metabolism and cognitive performance at baseline and two years following continuation or discontinuation of estrogen therapy.
We hypothesize that women who discontinue estrogen will show more evidence of decline than those who continue estrogen. This project will expand current knowledge of effects of estrogen by 1) determining whether estrogen use among postmenopausal women at risk for cognitive decline is protective of brain metabolism, 2) identifying early predictors for cognitive decline, and 3) developing guidelines for estrogen use in postmenopausal women.
- Keywords
- Aging, Menopause, Estrogen Replacement Therapy, Cognitive Decline
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Continue current hormone therapy | |
| 2 | Taper off hormone therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cognition and brain metabolism
Measured: Baseline and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2004 (estimated)
- Study startAug 2003
- Primary completionNov 2014
- Study completionNov 2014
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 AgingStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Natalie Rasgon, Stanford University
- Investigators
- Natalie Rasgon, MD, PhD, Principal investigator, Stanford University School of Medicine, Dept of Psychiatry and Behavioral SciencesTerence Ketter, MD, Principal investigator, Stanford UniversityJerome Yesavage, MD, Principal investigator, Stanford UniversityJennifer Hoblyn, MD, Principal investigator, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00097058
- Sponsor's protocol ID
- IA0063
- Other IDs
- R01AG022008, SPO #29004, Grant #R01 AG022008
- Status last verified
- Nov 2014
- First submitted
- 17 Nov 2004
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rasgon NL, Small GW, Siddarth P, Miller K, Ercoli LM, Bookheimer SY, Lavretsky H, Huang SC, Barrio JR, Phelps ME. Estrogen use and brain metabolic change in older adults. A preliminary report. Psychiatry Res. 2001 Jul 1;107(1):11-8. doi: 10.1016/s0925-4927(01)00084-1.
PubMed 11472860Rasgon NL, Thomas MA, Guze BH, Fairbanks LA, Yue K, Curran JG, Rapkin AJ. Menstrual cycle-related brain metabolite changes using 1H magnetic resonance spectroscopy in premenopausal women: a pilot study. Psychiatry Res. 2001 Feb 28;106(1):47-57. doi: 10.1016/s0925-4927(00)00085-8.
PubMed 11231099Dunkin J, Rasgon N, Wagner-Steh K, David S, Altshuler L, Rapkin A. Reproductive events modify the effects of estrogen replacement therapy on cognition in healthy postmenopausal women. Psychoneuroendocrinology. 2005 Apr;30(3):284-96. doi: 10.1016/j.psyneuen.2004.09.002.
PubMed 15511602Rasgon NL, Geist CL, Kenna HA, Wroolie TE, Williams KE, Silverman DH. Prospective randomized trial to assess effects of continuing hormone therapy on cerebral function in postmenopausal women at risk for dementia. PLoS One. 2014 Mar 12;9(3):e89095. doi: 10.1371/journal.pone.0089095. eCollection 2014.
PubMed 24622517
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estrogen Use in Protection From Cognitive Decline
- ClinicalTrials.gov ID
- NCT00097058
- Acronym / sponsor ID
- IA0063
- Keywords
- Aging, Menopause, Estrogen Replacement Therapy, Cognitive Decline
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Aug 2003
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 18 Nov 2004 (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 study is designed to assess the effects of estrogen therapy among postmenopausal women at risk for cognitive decline.
Detailed description
A total of 71 postmenopausal women ages 50-65 on estrogen therapy will be randomized to continue or discontinue use of estrogen and will be followed for two years.
Participants will undergo PET and MRI scans and neuropsychological assessments initially and at the end of the two-year follow-up period. These procedures will allow us to evaluate brain metabolism and cognitive performance at baseline and two years following continuation or discontinuation of estrogen therapy.
We hypothesize that women who discontinue estrogen will show more evidence of decline than those who continue estrogen. This project will expand current knowledge of effects of estrogen by 1) determining whether estrogen use among postmenopausal women at risk for cognitive decline is protective of brain metabolism, 2) identifying early predictors for cognitive decline, and 3) developing guidelines for estrogen use in postmenopausal women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Continue current hormone therapy |
| 2 | – | –Taper off hormone therapy |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women between the ages of 45 and 65 years of age, currently on estrogen therapy for 1 year prior to enrollment in study, and at risk for cognitive decline.
Key inclusion criteria (9 listed)
- Women between the ages of 45 and 65
- Currently on hormone replacement
- One year or more post complete cessation of menses
- Willing to sign the Human Subject Protection Consent form prior to enrollment in the study
- Willing to be randomized to continue or discontinue estrogen therapy
Key exclusion criteria (5 listed)
- Diagnosis of possible or probable Alzheimer's disease or dementia
- Cerebrovascular disease or uncontrolled hypertension (systolic BP >170 or diastolic BP >100)
- History of myocardial infarction within previous year or unstable heart disease
- History of significant liver disease, pulmonary disease, or current cancer
- Contraindication for MRI (metal in body, claustrophobia, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in cognition and brain metabolism
Time frame: Baseline and 24 months
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 19 Nov 2014.
- Background: PubMed 11472860Rasgon NL, Small GW, Siddarth P, Miller K, Ercoli LM, Bookheimer SY, Lavretsky H, Huang SC, Barrio JR, Phelps ME. Estrogen use and brain metabolic change in older adults. A preliminary report. Psychiatry Res. 2001 Jul 1;107(1):11-8. doi: 10.1016/s0925-4927(01)00084-1.
- Background: PubMed 11231099Rasgon NL, Thomas MA, Guze BH, Fairbanks LA, Yue K, Curran JG, Rapkin AJ. Menstrual cycle-related brain metabolite changes using 1H magnetic resonance spectroscopy in premenopausal women: a pilot study. Psychiatry Res. 2001 Feb 28;106(1):47-57. doi: 10.1016/s0925-4927(00)00085-8.
- Background: PubMed 15511602Dunkin J, Rasgon N, Wagner-Steh K, David S, Altshuler L, Rapkin A. Reproductive events modify the effects of estrogen replacement therapy on cognition in healthy postmenopausal women. Psychoneuroendocrinology. 2005 Apr;30(3):284-96. doi: 10.1016/j.psyneuen.2004.09.002.
- Derived from this study: PubMed 24622517Rasgon NL, Geist CL, Kenna HA, Wroolie TE, Williams KE, Silverman DH. Prospective randomized trial to assess effects of continuing hormone therapy on cerebral function in postmenopausal women at risk for dementia. PLoS One. 2014 Mar 12;9(3):e89095. doi: 10.1371/journal.pone.0089095. eCollection 2014.
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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.
Natalie Rasgon, MD, PhD principal investigator
Stanford University School of Medicine, Dept of Psychiatry and Behavioral Sciences
Terence Ketter, MD principal investigator
Stanford University
Jerome Yesavage, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Menopause, run by Stanford University at 1 site 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 9 inclusion and 5 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 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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.
What does the primary outcome measure?
Changes in cognition and brain metabolism (time frame: Baseline and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00097058, 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 19 Nov 2014.