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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00239759
First received: October 13, 2005
Last updated: February 24, 2009
Last verified: February 2009
  Purpose

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


Condition
Alzheimer's Disease

Study Type: Observational
Official Title: Genetic Epidemiological Studies of Apolipoprotein E and Alzheimer's Disease

Resource links provided by NLM:


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

Estimated Enrollment: 2000
Study Start Date: September 2002
Study Completion Date: June 2008
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239759

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00239759     History of Changes
Other Study ID Numbers: IA0085, 2R01AG0902911-A2
Study First Received: October 13, 2005
Last Updated: February 24, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Epidemiological study

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014