Alzheimer's Disease Prevention Trial - Full Text View

Purpose

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.

Condition	Intervention	Phase
Alzheimer Disease Memory Disorders	Drug: Estrogen Drug: Estrogen and Progesterone	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Prevention
Official Title:	Alzheimer's Disease Prevention Trial. A Multi-center, Randomized, Double-blind Placebo Controlled Trial of Estrogens to Prevent Alzheimer's Disease and Loss of Memory in Women.

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Memory

Drug Information available for: Progesterone

U.S. FDA Resources

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

Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000176

Locations

United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, California
University of California, Irvine
Irvine, California, United States, 29697-4540
United States, Connecticut
New England Center for Headache
Stamford, Connecticut, United States, 06902-1249
United States, District of Columbia
Howard University
Washington, District of Columbia, United States, 20060
United States, Florida
Lee Memorial Health System
Fort Myers, Florida, United States, 33901
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32225
Wein Center
Miami Beach, Florida, United States, 33140
West Florida Regional Medical Center
Pensacola, Florida, United States, 32514
North Broward Medical Center
Pompano Beach, Florida, United States
Tallahassee Memorial Health Center
Tallahassee, Florida, United States, 32308
St. Mary's Medical Center
West Palm Beach, Florida, United States, 33407
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
United States, New Jersey
Neurology Group of Bergen County
Ridgewood, New Jersey, United States, 07450
United States, New York
Columbia University
New York, New York, United States, 10032
Cornell Medical Center, New York Presbyterian Medical Center
New York, New York, United States
New York United Hospital Medical Center
Port Chester, New York, United States, 10573
Burke Medical Research Institute
White Plains, New York, United States, 10605
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oklahoma
Clinical Pharmaceutical Trials
Tulsa, Oklahoma, United States, 74104-5428
United States, Rhode Island
Butler Hospital, Rhode Island Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
Medical University of South Carolina
North Charleston, South Carolina, United States, 29406
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507-1912

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Mary Sano, PhD

Mount Sinai School of Medicine

More Information

Publications:

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. Review.

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.

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. Erratum in: Neurology 1998 Aug;51(2):654.

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.

ClinicalTrials.gov Identifier:	NCT00000176 History of Changes
Other Study ID Numbers:	IA0018, RO 1AG15922-01
Study First Received:	October 29, 1999
Last Updated:	November 3, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

Alzheimer's disease
memory loss
Estrogen

Additional relevant MeSH terms:

Alzheimer Disease
Memory Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Estrogens
Progesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Progestins

ClinicalTrials.gov processed this record on May 23, 2013