Alzheimer's Disease Prevention Trial

NCT00000176 | Completed Phase 3

• 2 other identifiers: IA0018RO 1AG15922-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 22

Brief Summary

This is a three-year study to determine if estrogens can prevent memory loss and Alzheimer's disease in women with a family history of Alzheimer's disease.

Conditions

Alzheimer Disease; Memory Disorders

Keywords

Alzheimer's disease; memory loss; Estrogen

Interventions

Estrogen DRUG

Estrogen and Progesterone DRUG

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Healthy women 65 or older with a family history of memory problems not currently on estrogen.

You may not qualify if:

• Significant neurological impairment
• Current estrogen use
• History of breast cancer

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (22)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

University of California, Irvine

Irvine, California, 29697-4540, United States

Location

New England Center for Headache

Stamford, Connecticut, 06902-1249, United States

Location

Howard University

Washington D.C., District of Columbia, 20060, United States

Location

Lee Memorial Health System

Fort Myers, Florida, 33901, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32225, United States

Location

Wein Center

Miami Beach, Florida, 33140, United States

Location

West Florida Regional Medical Center

Pensacola, Florida, 32514, United States

Location

North Broward Medical Center

Pompano Beach, Florida, United States

Location

Tallahassee Memorial Health Center

Tallahassee, Florida, 32308, United States

Location

St. Mary's Medical Center

West Palm Beach, Florida, 33407, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Neurology Group of Bergen County

Ridgewood, New Jersey, 07450, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Cornell Medical Center, New York Presbyterian Medical Center

New York, New York, United States

Location

New York United Hospital Medical Center

Port Chester, New York, 10573, United States

Location

Burke Medical Research Institute

White Plains, New York, 10605, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Clinical Pharmaceutical Trials

Tulsa, Oklahoma, 74104-5428, United States

Location

Butler Hospital, Rhode Island Hospital

Providence, Rhode Island, 02906, United States

Location

Medical University of South Carolina

North Charleston, South Carolina, 29406, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507-1912, United States

Location

Related Publications (4)

• Tang MX, Jacobs D, Stern Y, Marder K, Schofield P, Gurland B, Andrews H, Mayeux R. Effect of oestrogen during menopause on risk and age at onset of Alzheimer's disease. Lancet. 1996 Aug 17;348(9025):429-32. doi: 10.1016/S0140-6736(96)03356-9.

  PMID: 8709781 BACKGROUND

• Kawas C, Resnick S, Morrison A, Brookmeyer R, Corrada M, Zonderman A, Bacal C, Lingle DD, Metter E. A prospective study of estrogen replacement therapy and the risk of developing Alzheimer's disease: the Baltimore Longitudinal Study of Aging. Neurology. 1997 Jun;48(6):1517-21. doi: 10.1212/wnl.48.6.1517.

  PMID: 9191758 BACKGROUND

• Jacobs DM, Tang MX, Stern Y, Sano M, Marder K, Bell KL, Schofield P, Dooneief G, Gurland B, Mayeux R. Cognitive function in nondemented older women who took estrogen after menopause. Neurology. 1998 Feb;50(2):368-73. doi: 10.1212/wnl.50.2.368.

  PMID: 9484355 BACKGROUND

• Aloysi A, Van Dyk K, Sano M. Women's cognitive and affective health and neuropsychiatry. Mt Sinai J Med. 2006 Nov;73(7):967-75.

  PMID: 17195882 RESULT

MeSH Terms

Conditions

Alzheimer Disease; Memory Disorders

Interventions

Estrogens; Progesterone

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Mary Sano, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 29, 1999
• First Posted: November 1, 1999
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: November 5, 2010

Record last verified: 2010-11

Locations

US (22)