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| Sponsor: | National Institute on Aging (NIA) |
|---|---|
| Collaborators: |
Alzheimer's Disease Cooperative Study (ADCS) National Institute for Biomedical Imaging and Bioengineering (NIBIB) Foundation for the National Institutes of Health Alzheimer’s Drug Discovery Foundation Alzheimer's Association |
| Information provided by: | National Institute on Aging (NIA) |
| ClinicalTrials.gov Identifier: | NCT00106899 |
Purpose
The purpose of this study is to examine how brain imaging technology can be used with other tests to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). This information will aid future clinical trials by providing a standard assessment tool to measure the effects of treatments being studied.
| Condition | Intervention |
|---|---|
|
Alzheimer's Disease |
Procedure: Magnetic Resonance Imaging (MRI) Procedure: Positron Emission Tomography (PET) Procedure: Lumbar Puncture (LP) |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| Official Title: | Alzheimer's Disease Neuroimaging Initiative |
blood, urine, cerebrospinal fluid
| Estimated Enrollment: | 800 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Mild Cognitive Impairment (MCI); scans performed at screening/baseline, 6, 12, 18, 24, and 36 months
|
Procedure: Magnetic Resonance Imaging (MRI)
MRI scans
Procedure: Positron Emission Tomography (PET)
PET scans
Procedure: Lumbar Puncture (LP)
collection of cerebrospinal fluid
|
|
2
Early Alzheimer's disease (AD); scans performed at screening/baseline, 6, 12, and 24 months
|
Procedure: Magnetic Resonance Imaging (MRI)
MRI scans
Procedure: Positron Emission Tomography (PET)
PET scans
Procedure: Lumbar Puncture (LP)
collection of cerebrospinal fluid
|
|
3
Unaffected/normal controls; scans performed at baseline/screening, 6, 12, 24, and 36 months
|
Procedure: Magnetic Resonance Imaging (MRI)
MRI scans
Procedure: Positron Emission Tomography (PET)
PET scans
Procedure: Lumbar Puncture (LP)
collection of cerebrospinal fluid
|
This study will test whether serial magnetic resonance imaging (MRI), positron emission tomography (PET), other biological markers, and clinical and neuropsychological assessment can be combined to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). The information obtained by studying changes in the brain images of MCI and AD patients and healthy individuals, as well as other assessment tools, will be used to determine the best methods for measuring treatment effects in patients with MCI and AD.
Approximately 800 participants, ranging in age from 55 to 90, will be recruited for the study: 400 patients with MCI, 200 with early AD, and 200 normal controls. Patients with MCI and normal controls will be followed for 3 years, and those with AD will be followed for 2 years. At 6-month intervals, all participants will be seen in person or contacted by telephone. All participants will undergo repeated scanning and blood and urine biomarkers will be collected at the time of each scan. All patients will be asked if they are willing to undergo lumbar puncture at baseline and year one, with the goal of a minimum of 20% and as many as 50% of each group providing CSF (cerebrospinal fluid) samples for analysis and storage for future analyses.
NOTE: Beginning in Spring 2007 a subset of the ADNI participants will be offered the opportunity to participate in a supplemental study. The PIB (Pittsburgh Compound B) study provides imaging of amyloid plaque burden. PIB PET scans will be conducted in 24 control, 48 MCI, and 24 AD participants at approximately 16 ADNI PET sites. For entering participants with no previous PET FDG scans, controls and MCI participants will be scanned with PIB at entry (baseline), 12, 24, and 36 months, and AD participants will be scanned with PIB at entry (baseline), 12, and 24 months. For participants who have undergone previous (baseline and 6 month) PET FDG scans, controls and MCI participants will be scanned with PIB at 12, 24, and 36 months, and AD participants will be scanned with PIB at 12 and 24 months.
Eligibility| Ages Eligible for Study: | 55 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
community sample
Inclusion Criteria:
Participants will be classified as either MCI patients, AD patients, or normal controls. General Inclusion Criteria will apply to all groups, with specific criteria for each group as described below:
General (applies to each category):
Specific Criteria for MCI and AD patients:
Exclusion Criteria:
Specific Exclusion Criteria for MCI and AD:
Prohibited medications:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| University of Alabama | |
| Birmingham, Alabama, United States, 35233 | |
| United States, Arizona | |
| Sun Health / Arizona Consortium | |
| Sun City, Arizona, United States, 85351 | |
| Banner Good Samaritan Medical Center | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| University of California, Los Angeles | |
| Los Angeles, California, United States, 90095 | |
| University of California, Davis | |
| Sacramento, California, United States, 95817 | |
| University of California, Irvine | |
| Irvine, California, United States, 92697-4285 | |
| Stanford University | |
| Stanford, California, United States, 94304 | |
| University of California, San Diego | |
| La Jolla, California, United States, 92037 | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94115 | |
| University of Southern California | |
| Los Angeles, California, United States, 90033 | |
| University of California, Irvine - Brain Imaging Center | |
| Irvine, California, United States, 92697 | |
| United States, Connecticut | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06510 | |
| Olin Neuropsychiatry Research Center | |
| Hartford, Connecticut, United States, 06106 | |
| United States, District of Columbia | |
| Georgetown University | |
| Washington, District of Columbia, United States, 20057 | |
| Howard University | |
| Washington, District of Columbia, United States, 20060 | |
| United States, Florida | |
| Mayo Clinic, Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| Premiere Neurological Group | |
| West Palm Beach, Florida, United States, 33407 | |
| Wein Center | |
| Miami, Florida, United States, 33140 | |
| Byrd Alzheimer's Institute | |
| Tampa, Florida, United States, 33647 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Rush University Medical Center/Presbyterian St. Luke's Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202-5120 | |
| United States, Kansas | |
| University of Kansas | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Kentucky | |
| University of Kentucky | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21287-7218 | |
| United States, Massachusetts | |
| Boston University Schools of Medicine and Public Health | |
| Boston, Massachusetts, United States, 02118 | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Minnesota | |
| Mayo Clinic, Rochester | |
| Rochester, Minnesota, United States, 55901-0144 | |
| United States, Missouri | |
| Washington University | |
| St. Louis, Missouri, United States, 63108 | |
| United States, Nevada | |
| University of Nevada School of Medicine | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New Hampshire | |
| Dartmouth Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New York | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14620 | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| New York University | |
| New York, New York, United States, 10016 | |
| Columbia University | |
| New York, New York, United States, 11032 | |
| Albany Medical College | |
| Albany, New York, United States, 12208 | |
| Dent Neurological Institute | |
| Amherst, New York, United States, 14266 | |
| Neurological Care of CNY | |
| Syracuse, New York, United States, 13210 | |
| Dent Neurological Institute | |
| Orchard Park, New York, United States, 14127 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27705 | |
| Wake Forest University | |
| Winston Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Case Western Reserve University | |
| Cleveland, Ohio, United States, 44120 | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oregon | |
| Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Jefferson University | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| North Charleston, South Carolina, United States, 29406 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| University of Texas Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53706 | |
| Canada, British Columbia | |
| University of British Columbia | |
| Vancouver, British Columbia, Canada, V6T 2B5 | |
| Canada, Ontario | |
| Parkwood Hospital | |
| London, Ontario, Canada | |
| Saint Joseph's Hospital | |
| London, Ontario, Canada | |
| Sunnybrook and Women's College, Health Sciences Centre, University of Toronto | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Jewish Hospital Memory Clinic, Quebec | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Principal Investigator: | Michael W. Weiner, MD | University of California, San Francisco |
| Principal Investigator: | Ronald Petersen, MD, PhD | Mayo Clinic, Rochester, Minnesota |
| Principal Investigator: | Paul Aisen, MD | University of California, San Diego |
More Information
| Responsible Party: | Alzheimer's Disease Cooperative Study ( Paul Aisen, MD ) |
| Study ID Numbers: | IA0068, 1U01AG024904 |
| Study First Received: | March 31, 2005 |
| Last Updated: | June 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00106899 History of Changes |
| Health Authority: | United States: Federal Government |
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neuroimaging brain metabolism biomarkers cognition disorder Mild Cognitive Impairment |
|
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nervous System Diseases Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Tauopathies Brain Diseases Dementia |