Alzheimer's Disease Prevention Trial

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.

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Memory Disorders
• Intervention / Treatment: Drug: Estrogen; Drug: Estrogen and Progesterone

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.

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Masking: Double

Collaborators and Investigators

• Sponsor: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Mary Sano, PhD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• 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.
• 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. 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. doi: 10.1212/wnl.50.2.368.
• 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.

Study record dates

Study Major Dates

• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: October 29, 1999
• First Submitted That Met QC Criteria: October 29, 1999
• First Posted (Estimate): November 1, 1999

Study Record Updates

• Last Update Posted (Estimate): November 5, 2010
• Last Update Submitted That Met QC Criteria: November 3, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Alzheimer's disease; Estrogen; memory loss
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Memory Disorders; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone; Estrogens
• Other Study ID Numbers: IA0018; RO 1AG15922-01