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


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

This study is no longer recruiting patients.

Sponsors and Collaborators: National Center for Research Resources (NCRR)
Alzheimer's Association
Pfizer
Eisai Medical Research Inc
Information provided by: National Institute on Aging (NIA)

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

MedlinePlus related topics:  Alzheimer's Caregivers;   Alzheimer's Disease
Genetics Home Reference related topics:  Alzheimer disease

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: 

Expected Total Enrollment:  45

Study start: September 1999;  Study completion: August 2003

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).

Eligibility

Ages Eligible for Study:  45 Years   -   85 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

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.

Location Information


Vermont
      Clinical Neuroscience Research Unit, University of Vermont, Burlington,  Vermont,  05401,  United States

Study chairs or principal investigators

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

More Information

University of Vermont, Clinical Neuroscience Research Unit

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.

Newhouse 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.

Newhouse 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 ID Numbers:  IA0023
Record last reviewed:  December 2004
Last Updated:  December 2, 2004
Record first received:  August 18, 2000
ClinicalTrials.gov Identifier:  NCT00006399
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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Page Updated: June 1, 2005
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