Alzheimer's DiseaseNCT00239759
MIRAGE: Multi-Institutional Research in Alzheimer's Genetic Epidemiology
An observational study of Alzheimer's Disease, run by National Institute on Aging (NIA) at 15 sites in 4 countries.
Trial summary
The goal of MIRAGE is to evaluate the association of genetic and non-genetic risk factors for Alzheimer's Disease. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 2,000 participants
- Where
- 15 sitesin 4 countries
- Study dates
- Sep 2002to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
United States12 sites
Morehouse School of Medicine
Atlanta, Georgia, 30310
University of Alabama
Birmingham, Alabama, 35233
Boston University School of Medicine
Boston, Massachusetts, 02118
Case Western Reserve University
Cleveland, Ohio, 44106
Rancho Los Amigos National Rehabilitation Center/University of Southern California
Downey, California, 90242
Pacific Health Research Institute
Honolulu, Hawaii, 96817
Indiana University School of Medicine
Indianapolis, Indiana, 46202
University of Miami School of Medicine
Miami Beach, Florida, 33140
Cornell Medical University
New York, New York, 10021
University of California, Davis
Sacramento, California, 95817
Sun Health Research Institute
Sun City, Arizona, 85351
Howard University
Washington D.C., District of Columbia, 20060
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T 2B5
About this study
Official title: 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.
Read the 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.
- Conditions
- Alzheimer's Disease
- Keywords
- Epidemiological study
- Medical subject headings
- Alzheimer Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startSep 2002
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Lindsay Farrer, PhD, Principal investigator, Chief, Genetics Program, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239759
- Sponsor's protocol ID
- IA0085
- Other IDs
- 2R01AG0902911-A2
- Status last verified
- Feb 2009
- First submitted
- 13 Oct 2005
- Last updated
- 25 Feb 2009
- Results posted
- No
Publications
Bachman DL, Green RC, Benke KS, Cupples LA, Farrer LA; MIRAGE Study Group. Comparison of Alzheimer's disease risk factors in white and African American families. Neurology. 2003 Apr 22;60(8):1372-4. doi: 10.1212/01.wnl.0000058751.43033.4d.
PubMed 12707449Green RC, Cupples LA, Kurz A, Auerbach S, Go R, Sadovnick D, Duara R, Kukull WA, Chui H, Edeki T, Griffith PA, Friedland RP, Bachman D, Farrer L. Depression as a risk factor for Alzheimer disease: the MIRAGE Study. Arch Neurol. 2003 May;60(5):753-9. doi: 10.1001/archneur.60.5.753.
PubMed 12756140Henderson VW, Benke KS, Green RC, Cupples LA, Farrer LA; MIRAGE Study Group. Postmenopausal hormone therapy and Alzheimer's disease risk: interaction with age. J Neurol Neurosurg Psychiatry. 2005 Jan;76(1):103-5. doi: 10.1136/jnnp.2003.024927.
PubMed 15608005Yip AG, Green RC, Huyck M, Cupples LA, Farrer LA; MIRAGE Study Group. Nonsteroidal anti-inflammatory drug use and Alzheimer's disease risk: the MIRAGE Study. BMC Geriatr. 2005 Jan 12;5:2. doi: 10.1186/1471-2318-5-2.
PubMed 15647106Yip AG, McKee AC, Green RC, Wells J, Young H, Cupples LA, Farrer LA. APOE, vascular pathology, and the AD brain. Neurology. 2005 Jul 26;65(2):259-65. doi: 10.1212/01.wnl.0000168863.49053.4d.
PubMed 16043796
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Epidemiological Studies of Apolipoprotein E and Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00239759
- Acronym / sponsor ID
- IA0085
- Conditions
- Alzheimer's Disease
- Keywords
- Epidemiological study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Sep 2002
- Study completion
- Jun 2008 (actual)
- First posted
- 17 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of MIRAGE is to evaluate the association of genetic and non-genetic risk factors for Alzheimer's Disease.
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 design
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2009.
- Background: PubMed 12707449Bachman DL, Green RC, Benke KS, Cupples LA, Farrer LA; MIRAGE Study Group. Comparison of Alzheimer's disease risk factors in white and African American families. Neurology. 2003 Apr 22;60(8):1372-4. doi: 10.1212/01.wnl.0000058751.43033.4d.
- Background: PubMed 12756140Green RC, Cupples LA, Kurz A, Auerbach S, Go R, Sadovnick D, Duara R, Kukull WA, Chui H, Edeki T, Griffith PA, Friedland RP, Bachman D, Farrer L. Depression as a risk factor for Alzheimer disease: the MIRAGE Study. Arch Neurol. 2003 May;60(5):753-9. doi: 10.1001/archneur.60.5.753.
- Background: PubMed 15608005Henderson VW, Benke KS, Green RC, Cupples LA, Farrer LA; MIRAGE Study Group. Postmenopausal hormone therapy and Alzheimer's disease risk: interaction with age. J Neurol Neurosurg Psychiatry. 2005 Jan;76(1):103-5. doi: 10.1136/jnnp.2003.024927.
- Background: PubMed 15647106Yip AG, Green RC, Huyck M, Cupples LA, Farrer LA; MIRAGE Study Group. Nonsteroidal anti-inflammatory drug use and Alzheimer's disease risk: the MIRAGE Study. BMC Geriatr. 2005 Jan 12;5:2. doi: 10.1186/1471-2318-5-2.
- Background: PubMed 16043796Yip AG, McKee AC, Green RC, Wells J, Young H, Cupples LA, Farrer LA. APOE, vascular pathology, and the AD brain. Neurology. 2005 Jul 26;65(2):259-65. doi: 10.1212/01.wnl.0000168863.49053.4d.
- Boston University Alzheimer's Disease CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsay Farrer, PhD principal investigator
Chief, Genetics Program, Boston University
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by National Institute on Aging (NIA) at 15 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada, Germany, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00239759, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2009; AzTrials last refreshed its copy on 7 Nov 2026.