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Effects of Estrogen on Memory in Post-Menopausal Women and Patients With Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT00006399
Recruitment Status : Completed
First Posted : August 21, 2000
Last Update Posted : January 15, 2009
Alzheimer's Association
Eisai Inc.
Information provided by:
National Institute on Aging (NIA)

Brief 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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Donepezil Drug: Estrogen Drug: Progesterone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
Masking: Double
Primary Purpose: Treatment
Official Title: Estrogen Modulation Effects on Cholinergic Function in Normal Post-Menopausal Women and Patients With Alzheimer's Disease
Study Start Date : September 1999
Actual Primary Completion Date : March 2004
Actual Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Estrogens

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Women who are currently taking estrogen therapy.
  • Women who are smokers.
  • Women who have had breast cancer.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006399

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United States, Vermont
Clinical Neuroscience Research Unit, University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
National Center for Research Resources (NCRR)
Alzheimer's Association
Eisai Inc.
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Principal Investigator: Paul A. Newhouse, M.D. Memory Center, Department of Psychiatry, University of Vermont College of Medicine
Additional Information:
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Responsible Party: Paul A. Newhouse, M.D, Department of Psychiatry, University of Vermont College of Medicine
ClinicalTrials.gov Identifier: NCT00006399    
Other Study ID Numbers: IA0023
2R56AG021476 ( U.S. NIH Grant/Contract )
First Posted: August 21, 2000    Key Record Dates
Last Update Posted: January 15, 2009
Last Verified: January 2009
Keywords provided by National Institute on Aging (NIA):
Alzheimer disease
Estrogen therapy
Post-menopausal women
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Nootropic Agents