Study Results
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Basic Information
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COMPLETED
818 participants
OBSERVATIONAL
2005-07-31
2011-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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1
Mild Cognitive Impairment (MCI); scans performed at screening/baseline, 6, 12, 18, 24, and 36 months
Magnetic Resonance Imaging (MRI)
MRI scans
Positron Emission Tomography (PET)
PET scans
Lumbar Puncture (LP)
collection of cerebrospinal fluid
2
Early Alzheimer's disease (AD); scans performed at screening/baseline, 6, 12, and 24 months
Magnetic Resonance Imaging (MRI)
MRI scans
Positron Emission Tomography (PET)
PET scans
Lumbar Puncture (LP)
collection of cerebrospinal fluid
3
Unaffected/normal controls; scans performed at baseline/screening, 6, 12, 24, and 36 months
Magnetic Resonance Imaging (MRI)
MRI scans
Positron Emission Tomography (PET)
PET scans
Lumbar Puncture (LP)
collection of cerebrospinal fluid
Interventions
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Magnetic Resonance Imaging (MRI)
MRI scans
Positron Emission Tomography (PET)
PET scans
Lumbar Puncture (LP)
collection of cerebrospinal fluid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Between 55 and 90 years of age (Currently, ADNI sites are only recruiting volunteers age 70-90 among people with no memory problems)
* Study partner or caregiver to accompany patient to all scheduled visits
* Fluent in English or Spanish
* Permitted medications stable for at least 4 weeks prior to screening
* Adequate visual and auditory acuity to allow neuropsychological testing
* Good general health with no additional diseases expected to interfere with the study
* Women must be two years post-menopausal or surgically sterile
* Willing and able to complete all baseline assessments, and to participate in the 2-3 year protocol
* Willing to undergo neuroimaging and provide DNA and plasma samples as specified
* Completed 6 grades of education or sufficient work history to exclude mental retardation
* Modified Hachinski score \<=4
* Geriatric Depression Scale \<6
Specific Criteria for MCI and AD patients:
* Memory complaint by patient or study partner
* Abnormal memory function score on Wechsler Memory Scale (adjusted for education)
* Mini-Mental State Exam score between 24 and 30 (MCI) or 20 and 26 (AD)
* Clinical Dementia Rating = 0.5; Memory Box score at least 0.5 (MCI) or 1.0 (AD)
Exclusion Criteria
* Abnormal baseline MRI
* Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body
* Major depression, bipolar disorder, history of schizophrenia
* History of alcohol or substance abuse or dependency within the past 2 years
* Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
* Clinically significant laboratory abnormalities
* Residence in skilled nursing facility
* Participation in clinical studies involving neuropsychological measures being collected more than one time per year
* Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol.
Prohibited medications:
* Specific psychoactive medications (for example, certain antidepressants, anti-anxiety medications, sleeping pills, etc.)
* Warfarin (Coumadin)
* Investigational agents
55 Years
90 Years
ALL
Yes
Sponsors
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Northern California Institute of Research and Education
OTHER
National Institute on Aging (NIA)
NIH
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
NIH
Foundation for the National Institutes of Health
OTHER
Alzheimer's Drug Discovery Foundation
OTHER
Alzheimer's Association
OTHER
Alzheimer's Disease Cooperative Study (ADCS)
OTHER
Responsible Party
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Principal Investigators
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Michael W. Weiner, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Ronald Petersen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic - Rochester, Minnesota
Paul Aisen, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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University of Alabama
Birmingham, Alabama, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States
Sun Health / Arizona Consortium
Sun City, Arizona, United States
University of California, Irvine
Irvine, California, United States
University of California, Irvine - Brain Imaging Center
Irvine, California, United States
University of California, San Diego
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
University of California, Davis
Sacramento, California, United States
University of California, San Francisco
San Francisco, California, United States
Stanford University
Stanford, California, United States
Olin Neuropsychiatry Research Center
Hartford, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
Howard University
Washington D.C., District of Columbia, United States
Mayo Clinic, Jacksonville
Jacksonville, Florida, United States
Wein Center
Miami, Florida, United States
Byrd Alzheimer's Institute
Tampa, Florida, United States
Premiere Neurological Group
West Palm Beach, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center/Presbyterian St. Luke's Medical Center
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Kansas
Kansas City, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Johns Hopkins University
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boston University Schools of Medicine and Public Health
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
University of Nevada School of Medicine
Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Albany Medical College
Albany, New York, United States
Dent Neurological Institute
Amherst, New York, United States
New York University
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Columbia University
New York, New York, United States
Dent Neurological Institute
Orchard Park, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Neurological Care of CNY
Syracuse, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Case Western Reserve University
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Jefferson University
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
North Charleston, South Carolina, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Wisconsin
Madison, Wisconsin, United States
University of British Columbia
Vancouver, British Columbia, Canada
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
Jewish Hospital Memory Clinic, Quebec
Montreal, Quebec, Canada
Countries
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References
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Frank RA, Galasko D, Hampel H, Hardy J, de Leon MJ, Mehta PD, Rogers J, Siemers E, Trojanowski JQ; National Institute on Aging Biological Markers Working Group. Biological markers for therapeutic trials in Alzheimer's disease. Proceedings of the biological markers working group; NIA initiative on neuroimaging in Alzheimer's disease. Neurobiol Aging. 2003 Jul-Aug;24(4):521-36. doi: 10.1016/s0197-4580(03)00002-2. No abstract available.
Grundman M, Petersen RC, Ferris SH, Thomas RG, Aisen PS, Bennett DA, Foster NL, Jack CR Jr, Galasko DR, Doody R, Kaye J, Sano M, Mohs R, Gauthier S, Kim HT, Jin S, Schultz AN, Schafer K, Mulnard R, van Dyck CH, Mintzer J, Zamrini EY, Cahn-Weiner D, Thal LJ; Alzheimer's Disease Cooperative Study. Mild cognitive impairment can be distinguished from Alzheimer disease and normal aging for clinical trials. Arch Neurol. 2004 Jan;61(1):59-66. doi: 10.1001/archneur.61.1.59.
Petersen RC. Mild cognitive impairment clinical trials. Nat Rev Drug Discov. 2003 Aug;2(8):646-53. doi: 10.1038/nrd1155. No abstract available.
Yang S, Zhang X, Du X, Yan P, Zhang J, Wang W, Wang J, Zhang L, Sun H, Liu Y, Xu X, Di Y, Zhong J, Wu C, Reinhardt JD, Zheng Y, Wu T. Prediction of cognitive conversion within the Alzheimer's disease continuum using deep learning. Alzheimers Res Ther. 2025 Feb 13;17(1):41. doi: 10.1186/s13195-025-01686-x.
Miller AA, Sharp ES, Wang S, Zhao Y, Mecca AP, van Dyck CH, O'Dell RS; Alzheimer's Disease Neuroimaging Initiative (ADNI). Self-reported hearing loss is associated with faster cognitive and functional decline but not diagnostic conversion in the ADNI cohort. Alzheimers Dement. 2024 Nov;20(11):7847-7858. doi: 10.1002/alz.14252. Epub 2024 Sep 26.
Cullen NC, Leuzy A, Palmqvist S, Janelidze S, Stomrud E, Pesini P, Sarasa L, Allue JA, Proctor NK, Zetterberg H, Dage JL, Blennow K, Mattsson-Carlgren N, Hansson O. Individualized prognosis of cognitive decline and dementia in mild cognitive impairment based on plasma biomarker combinations. Nat Aging. 2021 Jan;1(1):114-123. doi: 10.1038/s43587-020-00003-5. Epub 2020 Nov 30.
Klingenberg M, Stark D, Eitel F, Budding C, Habes M, Ritter K; Alzheimer's Disease Neuroimaging Initiative. Higher performance for women than men in MRI-based Alzheimer's disease detection. Alzheimers Res Ther. 2023 Apr 20;15(1):84. doi: 10.1186/s13195-023-01225-6.
Behzad M, Zirak N, Madani GH, Baidoo L, Rezaei A, Karbasi S, Sadeghi M, Shafie M, Mayeli M, Alzheimer's Disease Neuroimaging Initiative. CSF-Targeted Proteomics Indicate Amyloid-Beta Ratios in Patients with Alzheimer's Dementia Spectrum. Int J Alzheimers Dis. 2023 Feb 6;2023:5336273. doi: 10.1155/2023/5336273. eCollection 2023.
Rouch L, Virecoulon Giudici K, Cantet C, Guyonnet S, Delrieu J, Legrand P, Catheline D, Andrieu S, Weiner M, de Souto Barreto P, Vellas B; Alzheimer's Disease Neuroimaging Initiative. Associations of erythrocyte omega-3 fatty acids with cognition, brain imaging and biomarkers in the Alzheimer's disease neuroimaging initiative: cross-sectional and longitudinal retrospective analyses. Am J Clin Nutr. 2022 Dec 19;116(6):1492-1506. doi: 10.1093/ajcn/nqac236.
Xu G, Zheng S, Zhu Z, Yu X, Jiang J, Jiang J, Chu Z; Alzheimer's Disease Neuroimaging Initiative. Association of tau accumulation and atrophy in mild cognitive impairment: a longitudinal study. Ann Nucl Med. 2020 Nov;34(11):815-823. doi: 10.1007/s12149-020-01506-2. Epub 2020 Aug 12.
Kennedy RE, Schneider LS, Cutter GR; Alzheimer's Disease Neuroimaging Initiative. Biomarker positive and negative subjects in the ADNI cohort: clinical characterization. Curr Alzheimer Res. 2012 Dec;9(10):1135-41. doi: 10.2174/156720512804142976.
Grill JD, Di L, Lu PH, Lee C, Ringman J, Apostolova LG, Chow N, Kohannim O, Cummings JL, Thompson PM, Elashoff D; Alzheimer's Disease Neuroimaging Initiative. Estimating sample sizes for predementia Alzheimer's trials based on the Alzheimer's Disease Neuroimaging Initiative. Neurobiol Aging. 2013 Jan;34(1):62-72. doi: 10.1016/j.neurobiolaging.2012.03.006. Epub 2012 Apr 13.
Schrag A, Schott JM; Alzheimer's Disease Neuroimaging Initiative. What is the clinically relevant change on the ADAS-Cog? J Neurol Neurosurg Psychiatry. 2012 Feb;83(2):171-3. doi: 10.1136/jnnp-2011-300881. Epub 2011 Oct 21.
Samtani MN, Farnum M, Lobanov V, Yang E, Raghavan N, Dibernardo A, Narayan V; Alzheimer's Disease Neuroimaging Initiative. An improved model for disease progression in patients from the Alzheimer's disease neuroimaging initiative. J Clin Pharmacol. 2012 May;52(5):629-44. doi: 10.1177/0091270011405497. Epub 2011 Jun 9.
Schneider LS, Insel PS, Weiner MW; Alzheimer's Disease Neuroimaging Initiative. Treatment with cholinesterase inhibitors and memantine of patients in the Alzheimer's Disease Neuroimaging Initiative. Arch Neurol. 2011 Jan;68(1):58-66. doi: 10.1001/archneurol.2010.343.
Schneider LS, Kennedy RE, Cutter GR; Alzheimer's Disease Neuroimaging Initiative. Requiring an amyloid-beta1-42 biomarker for prodromal Alzheimer's disease or mild cognitive impairment does not lead to more efficient clinical trials. Alzheimers Dement. 2010 Sep;6(5):367-77. doi: 10.1016/j.jalz.2010.07.004.
Related Links
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Alzheimer's Disease Neuroimaging Initiative--Additional Information
Laboratory of Neuro Imaging: Alzheimer's Disease Neuroimaging Initiative
Alzheimer's Disease Cooperative Study
ADEAR Center
Other Identifiers
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