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

This study is currently recruiting participants.
Verified by National Institute on Aging (NIA), September 2007

Sponsors and Collaborators: National Center for Research Resources (NCRR)
Alzheimer's Association
Pfizer
Eisai Inc.
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00006399
  Purpose

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 Intervention Phase
Alzheimer Disease
Drug: Donepezil
Drug: Estrogen
Drug: Progesterone
Phase II

Genetics Home Reference related topics:   Alzheimer disease   

MedlinePlus related topics:   Alzheimer's Disease    Memory    Menopause   

ChemIDplus related topics:   Progesterone    Donepezil    E 2020   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind, Placebo Control
Official Title:   Estrogen Modulation Effects on Cholinergic Function in Normal Post-Menopausal Women and Patients With Alzheimer's Disease

Further study details as provided by National Institute on Aging (NIA):

Estimated Enrollment:   45
Study Start Date:   September 1999
Estimated Study Completion Date:   March 2006

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.

  Eligibility
Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006399

Contacts
Contact: Julie Dumas, PhD     802-847-2523     julie.dumas@vtmednet.org    

Locations
United States, Vermont
Clinical Neuroscience Research Unit, University of Vermont     Recruiting
      Burlington, Vermont, United States, 05401
      Contact: Sally R. Nolan, MS     802-847-9488     Sally.Nolan@vtmednet.org    

Sponsors and Collaborators
National Center for Research Resources (NCRR)
Alzheimer's Association
Pfizer
Eisai Inc.

Investigators
Principal Investigator:     Paul A. Newhouse, M.D.     Memory Center, Department of Psychiatry, University of Vermont College of Medicine    
  More Information


University of Vermont, Clinical Neuroscience Research Unit  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   IA0023
First Received:   August 18, 2000
Last Updated:   September 19, 2007
ClinicalTrials.gov Identifier:   NCT00006399
Health Authority:   United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Alzheimer disease  
Estrogen therapy  
Post-menopausal women  

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Progesterone
Mental Disorders
Donepezil
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Menopause
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Progestins
Physiological Effects of Drugs
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Tauopathies
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 15, 2008




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