Alzheimer's Disease Prevention Trial

NCT ID: NCT00000176

Last Updated: 2010-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Completion Date

2007-09-30

Brief Summary

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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.

Detailed Description

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PREventing Postmenopausal memory loss and Alzheimer's with Replacement Estrogens (PREPARE) is a double-blind-placebo controlled trial to determine whether estrogen (or estrogen and progesterone) can delay the onset of memory loss or Alzheimer's Disease in elderly women with a family history of the disease.

Conditions

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Alzheimer Disease Memory Disorders

Keywords

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Alzheimer's disease memory loss Estrogen

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Estrogen

Intervention Type DRUG

Estrogen and Progesterone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Significant neurological impairment
* Current estrogen use
* History of breast cancer
Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role lead

Principal Investigators

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Mary Sano, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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University of Alabama

Birmingham, Alabama, United States

Site Status

University of California, Irvine

Irvine, California, United States

Site Status

New England Center for Headache

Stamford, Connecticut, United States

Site Status

Howard University

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

Site Status

Lee Memorial Health System

Fort Myers, Florida, United States

Site Status

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Site Status

Wein Center

Miami Beach, Florida, United States

Site Status

West Florida Regional Medical Center

Pensacola, Florida, United States

Site Status

North Broward Medical Center

Pompano Beach, Florida, United States

Site Status

Tallahassee Memorial Health Center

Tallahassee, Florida, United States

Site Status

St. Mary's Medical Center

West Palm Beach, Florida, United States

Site Status

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Site Status

Neurology Group of Bergen County

Ridgewood, New Jersey, United States

Site Status

Columbia University

New York, New York, United States

Site Status

Cornell Medical Center, New York Presbyterian Medical Center

New York, New York, United States

Site Status

New York United Hospital Medical Center

Port Chester, New York, United States

Site Status

Burke Medical Research Institute

White Plains, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Clinical Pharmaceutical Trials

Tulsa, Oklahoma, United States

Site Status

Butler Hospital, Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Medical University of South Carolina

North Charleston, South Carolina, United States

Site Status

Eastern Virginia Medical School

Norfolk, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 8709781 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9191758 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9484355 (View on PubMed)

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.

Reference Type RESULT
PMID: 17195882 (View on PubMed)

Other Identifiers

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RO 1AG15922-01

Identifier Type: -

Identifier Source: secondary_id

IA0018

Identifier Type: -

Identifier Source: org_study_id