Alzheimer DiseasePhase 2/3NCT00066157
Alzheimer's Disease: Therapeutic Potential of Estrogen
A Phase 2/3 study testing Transdermal estradiol and Medroxyprogesterone in people with Alzheimer Disease, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This is a 15-month study to determine the effectiveness of hormone replacement therapy in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 55 to 90 years, women only
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Transdermal estradiol and Medroxyprogesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Dec 2007
- Phase
- Phase 2/3
- 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 55 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women with Alzheimer's disease and without other dementias (diagnosed by study staff or from an outside clinic)
- Mini Mental State Examination score greater than 15/30
Who cannot join
- History of cancer of reproductive tissues
- History of deep vein thrombosis or blot clots
- Diabetes
- Heart disease or stroke
- Liver problems including hepatitis
- Severe vision or hearing problems
Show all 9Show fewer
- Tobacco use
- Lack of an adequate caregiver
- inability to perform psychometric testing
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Memory Research Program
Madison, Wisconsin, 53705
About this study
This is a 15-month study to determine the effectiveness of hormone replacement therapy in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease.
Read the detailed description
Estrogen is a naturally occurring hormone produced in a woman's body. The purpose of this 15-month study is to determine the effectiveness of hormone replacement therapy in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease and without other dementias.
Patients who volunteer for this study will either receive a patch containing 17-ß-estradiol or will receive an inactive placebo patch. In addition, patients will be given either medroxyprogesterone or an inactive placebo pill. Neither the volunteers nor the study staff will know which type of patch or pill a patient receives. Patients must be generally healthy and have mild-to-moderate dementia. There must be a patient caregiver who can watch for side effects and ensure that the patient takes the study medications on schedule. Patients will undergo neuropsychological tests and an evaluation of the ability to live independently at each visit as well as laboratory evaluations, such as the taking of blood. Each visit will last approximately 3 hours. A total of 160 participants are being recruited.
- Conditions
- Alzheimer Disease
- Being tested
- Transdermal estradiol, Medroxyprogesterone, Placebo Patch, Placebo
- Keywords
- Alzheimer disease, Hormone replacement therapy, Postmenopausal women
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal estradiolDrug
Also called 17 (beta) estradiol transdermal patch, Estrogen replacement therapy
50 micrograms (low-dose) or 100 micrograms (high-dose) transdermal 17-ß-estradiol patch, changed every 3 days, for 12 months
MedroxyprogesteroneDrug
Also called progesterone
2.5mg tablet daily for 12 months
Placebo PatchDrug
Transdermal placebo patch, changed every 3 days, for 12 months
PlaceboDrug
Placebo tablet daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | estradiol patch and medroxyprogesterone Receives: Drug: Transdermal estradiol; Drug: Medroxyprogesterone |
| 2 | Active comparator | estradiol patch and placebo pill Receives: Drug: Transdermal estradiol; Drug: Placebo |
| 3 | Active comparator | placebo patch and medroxyprogesterone Receives: Drug: Medroxyprogesterone; Drug: Placebo Patch |
| 4 | Placebo comparator | placebo patch and placebo pill Receives: Drug: Placebo Patch; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition: delayed recall on Buschke Selective Reminding Test; Stroop Interference condition--completion time and errors; Clinician-rated Interview Based Impression of Change
Measured: Baseline and 1, 3, 6, 12, and 15 months
Secondary outcomes (2)
Skills of Independent Living: Physical functioning Performance (PFP)
Measured: Baseline and 1, 3, 6, 12, and 15 months
Bioassays (Estradiol, estrone, medroxyprogesterone, FSH, influence of ApoE genotype in responsivity to estrogen)
Measured: Baseline and 1, 3, 6, 12, and 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2003 (estimated)
- Study startSep 2001
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Sanjay Asthana, MD, Principal investigator, University of Wisconsin - Madison, William S. Middleton VA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066157
- Sponsor's protocol ID
- 2001-477
- Other IDs
- R01AG017196-03, FDA IRB approval M1285, NIH grant AG17196-03, IA0048
- Status last verified
- Aug 2018
- First submitted
- 4 Aug 2003
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cholerton B, Gleason CE, Baker LD, Asthana S. Estrogen and Alzheimer's disease: the story so far. Drugs Aging. 2002;19(6):405-27. doi: 10.2165/00002512-200219060-00002.
PubMed 12149049Asthana S, Baker LD, Craft S, Stanczyk FZ, Veith RC, Raskind MA, Plymate SR. High-dose estradiol improves cognition for women with AD: results of a randomized study. Neurology. 2001 Aug 28;57(4):605-12. doi: 10.1212/wnl.57.4.605.
PubMed 11524467Asthana S, Craft S, Baker LD, Raskind MA, Birnbaum RS, Lofgreen CP, Veith RC, Plymate SR. Cognitive and neuroendocrine response to transdermal estrogen in postmenopausal women with Alzheimer's disease: results of a placebo-controlled, double-blind, pilot study. Psychoneuroendocrinology. 1999 Aug;24(6):657-77. doi: 10.1016/s0306-4530(99)00020-7.
PubMed 10399774
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alzheimer's Disease: Therapeutic Potential of Estrogen
- ClinicalTrials.gov ID
- NCT00066157
- Acronym / sponsor ID
- 2001-477
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer disease, Hormone replacement therapy, Postmenopausal women
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Sep 2001
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 5 Aug 2003 (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 15-month study to determine the effectiveness of hormone replacement therapy in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease.
Detailed description
Estrogen is a naturally occurring hormone produced in a woman's body. The purpose of this 15-month study is to determine the effectiveness of hormone replacement therapy in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease and without other dementias.
Patients who volunteer for this study will either receive a patch containing 17-ß-estradiol or will receive an inactive placebo patch. In addition, patients will be given either medroxyprogesterone or an inactive placebo pill. Neither the volunteers nor the study staff will know which type of patch or pill a patient receives. Patients must be generally healthy and have mild-to-moderate dementia. There must be a patient caregiver who can watch for side effects and ensure that the patient takes the study medications on schedule. Patients will undergo neuropsychological tests and an evaluation of the ability to live independently at each visit as well as laboratory evaluations, such as the taking of blood. Each visit will last approximately 3 hours. A total of 160 participants are being recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Transdermal estradiol, Drug: Medroxyprogesteroneestradiol patch and medroxyprogesterone |
| 2 | Active comparator | Drug: Transdermal estradiol, Drug: Placeboestradiol patch and placebo pill |
| 3 | Active comparator | Drug: Medroxyprogesterone, Drug: Placebo Patchplacebo patch and medroxyprogesterone |
| 4 | Placebo comparator | Drug: Placebo Patch, Drug: Placeboplacebo patch and placebo pill |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal women with Alzheimer's disease and without other dementias (diagnosed by study staff or from an outside clinic)
- Mini Mental State Examination score greater than 15/30
Key exclusion criteria (9 listed)
- History of cancer of reproductive tissues
- History of deep vein thrombosis or blot clots
- Diabetes
- Heart disease or stroke
- Liver problems including hepatitis
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 |
|---|---|---|
| Transdermal estradiolAlso: 17 (beta) estradiol transdermal patch, Estrogen replacement therapy50 micrograms (low-dose) or 100 micrograms (high-dose) transdermal 17-ß-estradiol patch, changed every 3 days, for 12 months | Drug | 1, 2 |
| MedroxyprogesteroneAlso: progesterone2.5mg tablet daily for 12 months | Drug | 1, 3 |
| Placebo PatchTransdermal placebo patch, changed every 3 days, for 12 months | Drug | 3, 4 |
| PlaceboPlacebo tablet daily for 12 months | Drug | 2, 4 |
Primary outcome
Cognition: delayed recall on Buschke Selective Reminding Test; Stroop Interference condition--completion time and errors; Clinician-rated Interview Based Impression of Change
Time frame: Baseline and 1, 3, 6, 12, and 15 months
2 secondary outcomes
Skills of Independent Living: Physical functioning Performance (PFP)
Time frame: Baseline and 1, 3, 6, 12, and 15 months
Bioassays (Estradiol, estrone, medroxyprogesterone, FSH, influence of ApoE genotype in responsivity to estrogen)
Time frame: Baseline and 1, 3, 6, 12, and 15 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 23 Aug 2018.
- Background: PubMed 12149049Cholerton B, Gleason CE, Baker LD, Asthana S. Estrogen and Alzheimer's disease: the story so far. Drugs Aging. 2002;19(6):405-27. doi: 10.2165/00002512-200219060-00002.
- Background: PubMed 11524467Asthana S, Baker LD, Craft S, Stanczyk FZ, Veith RC, Raskind MA, Plymate SR. High-dose estradiol improves cognition for women with AD: results of a randomized study. Neurology. 2001 Aug 28;57(4):605-12. doi: 10.1212/wnl.57.4.605.
- Background: PubMed 10399774Asthana S, Craft S, Baker LD, Raskind MA, Birnbaum RS, Lofgreen CP, Veith RC, Plymate SR. Cognitive and neuroendocrine response to transdermal estrogen in postmenopausal women with Alzheimer's disease: results of a placebo-controlled, double-blind, pilot study. Psychoneuroendocrinology. 1999 Aug;24(6):657-77. doi: 10.1016/s0306-4530(99)00020-7.
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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.
Sanjay Asthana, MD principal investigator
University of Wisconsin - Madison, William S. Middleton VA Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Transdermal estradiol and Medroxyprogesterone in people with Alzheimer Disease, run by University of Wisconsin, Madison 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 2 inclusion and 9 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 23 Aug 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
Cognition: delayed recall on Buschke Selective Reminding Test; Stroop Interference condition--completion time and errors; Clinician-rated Interview Based Impression of Change (time frame: Baseline and 1, 3, 6, 12, and 15 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 NCT00066157, which also lists 3 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 23 Aug 2018.