MIRAGE: Multi-Institutional Research in Alzheimer's Genetic Epidemiology

February 24, 2009 updated by: National Institute on Aging (NIA)

Genetic Epidemiological Studies of Apolipoprotein E and Alzheimer's Disease

The goal of MIRAGE is to evaluate the association of genetic and non-genetic risk factors for Alzheimer's Disease.

Study Overview

Status

Completed

Conditions

Detailed Description

For the past 13 years the MIRAGE project has demonstrated that genetic factors play a major role in the development of Alzheimer's Disease (AD) among patients ascertained in clinical settings. This research has also shown that the E4 variant of apolipoprotein E (APOE), is the strongest AD risk factor identified thus far.

The researchers are turning their attention to the growing body of evidence from pathological, epidemiological and genetic studies that risk factors for vascular disease also enhance the risk of AD. However, since most epidemiological studies lack neuroimaging data, it is unclear whether the apparent association between vascular risk factors and AD is brought about by ischemic injury to the brain, acceleration of the primary Alzheimer neurodegenerative process, or some other process.

Some vascular risk factors are more prevalent in African American and Japanese American populations than in Caucasians. This study will build upon earlier work by evaluating the association between APOE, genes involved in vascular function, and other indictors of cerebrovascular health including blood pressure and structural brain imaging (MRI), and susceptibility to AD in these ethnic groups.

In order to carry out this project successfully, a sample of 1000 patients (500 Caucasians, 300 African Americans, 200 Japanese Americans) who meet NINCDS/ADRDA criteria for probable or definite AD from 11 centers in the U.S., Canada and Germany will be recruited. Many patients will be identified from the existing family registries. Family history, medical history, and epidemiological information will be obtained from the AD patient and their first-degree relatives using standardized questionnaire instruments and established protocols. A cognitive screening test will be administered to and blood samples will be collected from the patient's living siblings, spouses and children over the age of 50 years. DNA, plasma and MRI of the brain will be evaluated in patients and siblings.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • University of British Columbia
  • Germany
      • Munich, Germany, P-81675
        • Technical University of Munich
  • Greece
      • Exholi Thessaloniki, Greece, S7010
        • G. Papanicolaou Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Sun Health Research Institute
    • California
      • Downey, California, United States, 90242
        • Rancho Los Amigos National Rehabilitation Center/University of Southern California
      • Sacramento, California, United States, 95817
        • University of California, Davis
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Howard University
    • Florida
      • Miami Beach, Florida, United States, 33140
        • University of Miami School of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30310
        • Morehouse School of Medicine
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Pacific Health Research Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University School Of Medicine
    • New York
      • New York City, New York, United States, 10021
        • Cornell Medical University
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

NOTE: This trial accepts patients with Probable AD, and their cognitively normal brothers or sisters

  • Probable or definite AD by NINCDS-ADRDA criteria
  • Living siblings who are cognitively normal as measured by a brief standardized cognitive assessment
  • Ages 60 and over for Alzheimer's disease patients
  • Ages 50 and over for cognitively normal siblings

Exclusion Criteria:

  • Early onset Alzheimer's disease attributed to APP, PS1 or PS2 gene mutations
  • History of clinical stroke
  • Siblings whose cognitive assessment does not meet study criteria
  • Pacemaker or other contraindication to MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Lindsay Farrer, PhD, Chief, Genetics Program, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

October 13, 2005

First Submitted That Met QC Criteria

October 13, 2005

First Posted (ESTIMATE)

October 17, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

February 25, 2009

Last Update Submitted That Met QC Criteria

February 24, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IA0085
  • 2R01AG0902911-A2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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