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

This study has been completed.
Sponsor:
Collaborators:
Alzheimer's Association
Pfizer
Eisai Inc.
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00006399
First received: August 18, 2000
Last updated: January 13, 2009
Last verified: January 2009
  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 2

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

Resource links provided by NLM:


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

Estimated Enrollment: 45
Study Start Date: September 1999
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Vermont
Clinical Neuroscience Research Unit, University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
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

Additional Information:
Publications:
Responsible Party: Paul A. Newhouse, M.D, Department of Psychiatry, University of Vermont College of Medicine
ClinicalTrials.gov Identifier: NCT00006399     History of Changes
Other Study ID Numbers: IA0023, 2R56AG021476
Study First Received: August 18, 2000
Last Updated: January 13, 2009
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Estrogens
Progesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins

ClinicalTrials.gov processed this record on October 21, 2014