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

NCT00006399 | Completed Phase 2

• 2 other identifiers: IA00232R56AG021476
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer disease; Estrogen therapy; Post-menopausal women

Interventions

Donepezil DRUG

Estrogen DRUG

Progesterone DRUG

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead
• Alzheimer's Association: collaborator
• Pfizer: collaborator
• Eisai Inc.: collaborator

Study Sites (1)

Clinical Neuroscience Research Unit, University of Vermont

Burlington, Vermont, 05401, United States

Location

Related Publications (3)

• 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.

  PMID: 1410163 BACKGROUND

• 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. doi: 10.1038/npp.1994.11.

  PMID: 8024677 BACKGROUND

• 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.

  BACKGROUND

Related Links

• University of Vermont, Clinical Neuroscience Research Unit

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil; Estrogens; Progesterone

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Corpus Luteum Hormones; Gonadal Hormones; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Paul A. Newhouse, M.D.

  Memory Center, Department of Psychiatry, University of Vermont College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 18, 2000
• First Posted: August 21, 2000
• Study Start: September 1, 1999
• Primary Completion: March 1, 2004
• Study Completion: March 1, 2004
• Last Updated: January 15, 2009

Record last verified: 2009-01

Locations

US (1)