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Alzheimer's Disease Prevention Trial

Primary Purpose

Alzheimer Disease, Memory Disorders

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Estrogen
Estrogen and Progesterone
Sponsored by
National Institute on Aging (NIA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alzheimer Disease focused on measuring Alzheimer's disease, memory loss, Estrogen

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alabama
  • University of California, Irvine
  • New England Center for Headache
  • Howard University
  • Lee Memorial Health System
  • Mayo Clinic Jacksonville
  • Wein Center
  • West Florida Regional Medical Center
  • North Broward Medical Center
  • Tallahassee Memorial Health Center
  • St. Mary's Medical Center
  • Johns Hopkins Bayview Medical Center
  • Neurology Group of Bergen County
  • Columbia University
  • Cornell Medical Center, New York Presbyterian Medical Center
  • New York United Hospital Medical Center
  • Burke Medical Research Institute
  • Duke University Medical Center
  • Clinical Pharmaceutical Trials
  • Butler Hospital, Rhode Island Hospital
  • Medical University of South Carolina
  • Eastern Virginia Medical School

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 29, 1999
Last Updated
November 3, 2010
Sponsor
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000176
Brief Title
Alzheimer's Disease Prevention Trial
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Aging (NIA)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Memory Disorders
Keywords
Alzheimer's disease, memory loss, Estrogen

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Estrogen
Intervention Type
Drug
Intervention Name(s)
Estrogen and Progesterone

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Sano, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
29697-4540
Country
United States
Facility Name
New England Center for Headache
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902-1249
Country
United States
Facility Name
Howard University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Lee Memorial Health System
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32225
Country
United States
Facility Name
Wein Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
West Florida Regional Medical Center
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32514
Country
United States
Facility Name
North Broward Medical Center
City
Pompano Beach
State/Province
Florida
Country
United States
Facility Name
Tallahassee Memorial Health Center
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
St. Mary's Medical Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Neurology Group of Bergen County
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cornell Medical Center, New York Presbyterian Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
New York United Hospital Medical Center
City
Port Chester
State/Province
New York
ZIP/Postal Code
10573
Country
United States
Facility Name
Burke Medical Research Institute
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Clinical Pharmaceutical Trials
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104-5428
Country
United States
Facility Name
Butler Hospital, Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Medical University of South Carolina
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1912
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8709781
Citation
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.
Results Reference
background
PubMed Identifier
9191758
Citation
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.
Results Reference
background
PubMed Identifier
9484355
Citation
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.
Results Reference
background
PubMed Identifier
17195882
Citation
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.
Results Reference
result

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Alzheimer's Disease Prevention Trial

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