Alzheimer DiseasePhase 2NCT00006399
Effects of Estrogen on Memory in Post-Menopausal Women and Patients With Alzheimer's Disease
A Phase 2 study testing Donepezil, Estrogen and Progesterone in people with Alzheimer Disease, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial summary
The goal of this study is to examine whether the administration of estrogen to post-menopausal women and women with mild to moderate Alzheimer's disease will enhance their memory and their capacity for learning. Read more about this study
- Who is it for?
- Ages 45 to 85 years, women only
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Donepezil, Estrogen and Progesterone
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1999to Mar 2004
- Phase
- Phase 2
- 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Normal volunteers and women with mild Alzheimer's disease:
- Non-smoker
- No use of Hormone Replacement Therapy for at least one year
- No menses for at least one year
- Normal mammogram within the last year
- minimum age is 45 for patients with Alzheimer's disease; 50 for normal volunteers
- Maximum age is 85 for patients with Alzheimer's disease; there is no maximum age for normal volunteers.
Who cannot join
- Women who are currently taking estrogen therapy.
- Women who are smokers.
- Women who have had breast cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Neuroscience Research Unit, University of Vermont
Burlington, Vermont, 05401
About this study
Official title: Estrogen Modulation Effects on Cholinergic Function in Normal Post-Menopausal Women and Patients With Alzheimer's Disease
The goal of this study is to examine whether the administration of estrogen to post-menopausal women and women with mild to moderate Alzheimer's disease will enhance their memory and their capacity for learning.
Read the detailed description
Estrogen (EST) may have significant benefits in preserving cognitive functioning in normal aging after menopause and in decreasing the incidence of Alzheimer's disease (AD). On a molecular level, EST has effects on a variety of cholinergic neuronal and receptor-mediated mechanisms that may be responsible for these beneficial effects. These neurons have critical relevance for the development of age-related cognitive changes and dementing disorders. However, little is known about the clinical relevance of EST-cholinergic interactions, either in normal aging or in AD.
The primary goal of this study is to test the hypothesis that three months of administration of EST to 1) normal post-menopausal women, and 2) female patients with mild-moderate AD who are concurrently treated with anticholinesterase therapy (donepezil), will positively change or blunt the negative and behavioral effects of drugs that block central cholinergic receptors (both muscarinic and nicotinic). Participants will be blindly placed on EST or placebo for three months each. After each three month period, they will be cognitively assessed after receiving single doses of the cholinergic antagonists scopolamine and mecamylamine. These results will have direct implications for the use of EST in post-menopausal women as well as interactive treatment with cholinergic drugs for AD. Researchers plan to recruit a total of 45 women (30 healthy, and 15 patients with AD).
NOTE: This study is only recruiting participants with Alzheimer's Disease at this time.
- Conditions
- Alzheimer Disease
- Being tested
- Donepezil, Estrogen, Progesterone
- Keywords
- Alzheimer disease, Estrogen therapy, Post-menopausal 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.
DonepezilDrug
EstrogenDrug
ProgesteroneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2000 (estimated)
- Study startSep 1999
- Primary completionMar 2004
- Study completionMar 2004
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.
- 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
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Alzheimer's Association, Pfizer, Eisai Inc.
- Investigators
- Paul A. Newhouse, M.D., Principal investigator, Memory Center, Department of Psychiatry, University of Vermont College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006399
- Sponsor's protocol ID
- IA0023
- Other IDs
- 2R56AG021476
- Status last verified
- Jan 2009
- First submitted
- 18 Aug 2000
- Last updated
- 15 Jan 2009
- Results posted
- No
Publications
Newhouse PA, Potter A, Corwin J, Lenox R. Acute nicotinic blockade produces cognitive impairment in normal humans. Psychopharmacology (Berl). 1992;108(4):480-4. doi: 10.1007/BF02247425.
PubMed 1410163Newhouse PA, Potter A, Corwin J, Lenox R. Age-related effects of the nicotinic antagonist mecamylamine on cognition and behavior. Neuropsychopharmacology. 1994 Apr;10(2):93-107. doi: 10.1038/npp.1994.11.
PubMed 8024677Newhouse PA, Potter A, Corwin J, Lenox, R. Effects of nicotinic cholinergic agents on cognitive functioning in Alzheimer's and Parkinson's disease. Drug Development Research 38:278-289, 1996.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estrogen Modulation Effects on Cholinergic Function in Normal Post-Menopausal Women and Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00006399
- Acronym / sponsor ID
- IA0023
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer disease, Estrogen therapy, Post-menopausal women
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- Alzheimer's Association, Pfizer, Eisai Inc.
- Study start
- Sep 1999
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 21 Aug 2000 (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.
The goal of this study is to examine whether the administration of estrogen to post-menopausal women and women with mild to moderate Alzheimer's disease will enhance their memory and their capacity for learning.
Detailed description
Estrogen (EST) may have significant benefits in preserving cognitive functioning in normal aging after menopause and in decreasing the incidence of Alzheimer's disease (AD). On a molecular level, EST has effects on a variety of cholinergic neuronal and receptor-mediated mechanisms that may be responsible for these beneficial effects. These neurons have critical relevance for the development of age-related cognitive changes and dementing disorders. However, little is known about the clinical relevance of EST-cholinergic interactions, either in normal aging or in AD.
The primary goal of this study is to test the hypothesis that three months of administration of EST to 1) normal post-menopausal women, and 2) female patients with mild-moderate AD who are concurrently treated with anticholinesterase therapy (donepezil), will positively change or blunt the negative and behavioral effects of drugs that block central cholinergic receptors (both muscarinic and nicotinic). Participants will be blindly placed on EST or placebo for three months each. After each three month period, they will be cognitively assessed after receiving single doses of the cholinergic antagonists scopolamine and mecamylamine. These results will have direct implications for the use of EST in post-menopausal women as well as interactive treatment with cholinergic drugs for AD. Researchers plan to recruit a total of 45 women (30 healthy, and 15 patients with AD).
NOTE: This study is only recruiting participants with Alzheimer's Disease at this time.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Normal volunteers and women with mild Alzheimer's disease:
- Non-smoker
- No use of Hormone Replacement Therapy for at least one year
- No menses for at least one year
- Normal mammogram within the last year
Key exclusion criteria (3 listed)
- Women who are currently taking estrogen therapy.
- Women who are smokers.
- Women who have had 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 |
|---|---|---|
| Donepezil | Drug | – |
| Estrogen | Drug | – |
| 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 15 Jan 2009.
- Background: PubMed 1410163Newhouse PA, Potter A, Corwin J, Lenox R. Acute nicotinic blockade produces cognitive impairment in normal humans. Psychopharmacology (Berl). 1992;108(4):480-4. doi: 10.1007/BF02247425.
- Background: PubMed 8024677Newhouse PA, Potter A, Corwin J, Lenox R. Age-related effects of the nicotinic antagonist mecamylamine on cognition and behavior. Neuropsychopharmacology. 1994 Apr;10(2):93-107. doi: 10.1038/npp.1994.11.
- BackgroundNewhouse PA, Potter A, Corwin J, Lenox, R. Effects of nicotinic cholinergic agents on cognitive functioning in Alzheimer's and Parkinson's disease. Drug Development Research 38:278-289, 1996.
- University of Vermont, Clinical Neuroscience Research UnitLink 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.
Paul A. Newhouse, M.D. principal investigator
Memory Center, Department of Psychiatry, University of Vermont College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Donepezil, Estrogen and Progesterone in people with Alzheimer Disease, run by National Center for Research Resources (NCRR) 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 7 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 15 Jan 2009. 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.
What does this 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.
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 NCT00006399, 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 15 Jan 2009.