Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1182 participants
OBSERVATIONAL
2011-02-14
2017-11-29
Brief Summary
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Detailed Description
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Some of the leading-edge technologies under study are brain-imaging techniques, such as positron emission tomography (PET), including FDG-PET (which measures glucose metabolism in the brain); PET using a radioactive compound (Florbetapir F 18) that measures brain beta-amyloid; and structural MRI. Brain scans are showing scientists how the brain's structure and function change as AD starts and progresses. Biomarkers in cerebrospinal fluid are revealing other changes that could identify which patients with MCI will develop Alzheimer's. Scientists are looking at levels of beta-amyloid and tau in cerebrospinal fluid. (Abnormal amounts of the amyloid and tau proteins in the brain are hallmarks of Alzheimer's disease.)
ADNI2 extends the work of ADNI1 and ADNI GO to understand the progression of AD. The overall goal is to determine the relationships among the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of AD, as the pathology evolves from normal aging through very mild symptoms, to MCI, to dementia.
The overall impact of this study will be increased knowledge concerning the sequence and timing of events leading to MCI and AD, development of better clinical and imaging/fluid biomarker methods for early detection and for monitoring the progression of these conditions, and facilitation of clinical trials to slow disease progression, ultimately contributing to the prevention of AD.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cognitively Normal (CN)
150 newly enrolled participants with no apparent memory problems, and CN participants followed from the ADNI1 study
Florbetapir
Participants will receive a single bolus intravenous injection of 10 mCi (370 MBq) (+/- 10%) florbetapir F18. At approximately 50-minutes post dose, scanning will begin. An approximately 20-minute image acquisition scan will be performed.
Flortaucipir
Participants will receive a single bolus intravenous injection of 10 mCi (370 MBq) flortaucipir injection followed by a saline flush. At approximately 75-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
Early Mild Cognitive Impairment (EMCI)
100 newly enrolled early amnestic MCI participants, and approximately 200 EMCI participants will be followed from the ADNI-GO study
Florbetapir
Participants will receive a single bolus intravenous injection of 10 mCi (370 MBq) (+/- 10%) florbetapir F18. At approximately 50-minutes post dose, scanning will begin. An approximately 20-minute image acquisition scan will be performed.
Flortaucipir
Participants will receive a single bolus intravenous injection of 10 mCi (370 MBq) flortaucipir injection followed by a saline flush. At approximately 75-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
Late Mild Cognitive Impairment (LMCI)
150 newly enrolled late MCI participants, and LMCI participants followed from the ADNI1 study
Florbetapir
Participants will receive a single bolus intravenous injection of 10 mCi (370 MBq) (+/- 10%) florbetapir F18. At approximately 50-minutes post dose, scanning will begin. An approximately 20-minute image acquisition scan will be performed.
Flortaucipir
Participants will receive a single bolus intravenous injection of 10 mCi (370 MBq) flortaucipir injection followed by a saline flush. At approximately 75-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
Alzheimer's Disease (AD)
150 newly enrolled mild AD participants
Florbetapir
Participants will receive a single bolus intravenous injection of 10 mCi (370 MBq) (+/- 10%) florbetapir F18. At approximately 50-minutes post dose, scanning will begin. An approximately 20-minute image acquisition scan will be performed.
Flortaucipir
Participants will receive a single bolus intravenous injection of 10 mCi (370 MBq) flortaucipir injection followed by a saline flush. At approximately 75-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
Significant Memory Concern (SMC)
100 newly enrolled participants with Significant Memory Concern (SMC)
Florbetapir
Participants will receive a single bolus intravenous injection of 10 mCi (370 MBq) (+/- 10%) florbetapir F18. At approximately 50-minutes post dose, scanning will begin. An approximately 20-minute image acquisition scan will be performed.
Flortaucipir
Participants will receive a single bolus intravenous injection of 10 mCi (370 MBq) flortaucipir injection followed by a saline flush. At approximately 75-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
Interventions
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Florbetapir
Participants will receive a single bolus intravenous injection of 10 mCi (370 MBq) (+/- 10%) florbetapir F18. At approximately 50-minutes post dose, scanning will begin. An approximately 20-minute image acquisition scan will be performed.
Flortaucipir
Participants will receive a single bolus intravenous injection of 10 mCi (370 MBq) flortaucipir injection followed by a saline flush. At approximately 75-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Geriatric Depression Scale less than 6.
* Age between \*55-90 (inclusive). \*For normal controls and SMC participants, age must be between 65-90.
* Study partner is available who has frequent contact with the participant (e.g. an average of 10 hours per week or more), and can accompany the participant to all clinic visits for the duration of the protocol.
* Visual and auditory acuity adequate for neuropsychological testing.
* Good general health with no diseases expected to interfere with the study.
* Participant is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile).
* Willing and able to participate in a longitudinal imaging study.
* Hachinski less than or equal to 4.
* Completed six grades of education or has a good work history (sufficient to exclude mental retardation).
* Must speak English or Spanish fluently.
* Willing to undergo repeated MRIs (3Tesla) and at least two PET scans (one FDG and one Amyloid imaging) and no medical contraindications to MRI.
* Agrees to collection of blood for Genome Wide Association Studies (GWAS), APOE testing and DNA and RNA banking.
* Agrees to collection of blood for biomarker testing.
* Agrees to at least one lumbar puncture for the collection of CSF.
* Participant must be free of memory complaints, verified by a study partner.
* Normal memory function score on Wechsler Memory Scale (adjusted for education)
* Mini-Mental State Exam (MMSE) score between 24 and 30 (inclusive)
* Clinical Dementia Rating (CDR) = 0; Memory Box score must be 0
* Cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living
* Stability of Permitted Medications for 4 weeks. In particular, participants may take:
* Antidepressants lacking significant anticholinergic side effects
* Estrogen replacement therapy is permissible
* Gingko biloba is permissible, but discouraged
* Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening
* Subjects that are "self-referrals" that have a significant subjective memory concern
* Significant memory concern confirmed by a Cognitive Change Index score of more than or equal to 16
* Normal memory function score on Wechsler Memory Scale (adjusted for education)
* Mini-Mental State Exam (MMSE) score between 24 and 30 (inclusive)
* Clinical Dementia Rating (CDR) = 0; Memory Box score must be 0
* Cognitively normal, based on the absence of significant memory impairment in cognitive function or activities of daily living
* Stability of Permitted Medications for 4 weeks. In particular, subjects may take:
* Antidepressants lacking significant anticholinergic side effects
* Estrogen replacement therapy is permissible
* Gingko biloba is permissible, but discouraged
* Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening
* Participant must have a subjective memory concern as reported by participant, study partner, or clinician
* Abnormal memory function score on Wechsler Memory Scale (adjusted for education)
* Mini-Mental State Exam (MMSE) score between 24 and 30 (inclusive)
* Clinical Dementia Rating (CDR) = 0.5; Memory Box score must be at least 0.5
* General cognition and functional performance sufficiently preserved such that a diagnosis of AD cannot be made by the site physician at the time of the screening visit
* Stability of Permitted Medications for 4 weeks. In particular, participants may take:
* Antidepressants lacking significant anticholinergic side effects
* Estrogen replacement therapy
* Gingko biloba is permissible, but discouraged
* Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening
* Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to screening
* Participant must have a subjective memory concern as reported by participant, study partner, or clinician
* Abnormal memory function score on Wechsler Memory Scale (adjusted for education)
* Mini-Mental State Exam (MMSE) score between 20 and 26 (inclusive)
* Clinical Dementia Rating (CDR) = 0.5 or 1.0
* National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD
* Stability of Permitted Medications for 4 weeks. In particular, participants may take:
* Antidepressants lacking significant anticholinergic side effects
* Estrogen replacement therapy
* Gingko biloba is permissible, but discouraged
* Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening
* Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to screening
* Must have been enrolled and followed in ADNI1 for at least one year or enrolled in ADNI-GO with original diagnosis of Cognitively Normal (CN), Mild Cognitive Impairment (MCI), or Early Mild Cognitive Impairment (EMCI) regardless of whether a diagnostic conversion has occurred since initial enrollment in ADNI.
* Willing and able to continue to participate in an ongoing longitudinal study. A reduced battery of tests is allowable if the participant is not able/willing to complete the full battery.
* Study partner is available who has frequent contact with the participant (e.g. an average of 10 hours per week or more), and can accompany the participant to all clinic visits for the duration of the protocol.
Exclusion Criteria
* Screening/baseline MRI scan with evidence of infection, infarction, or other focal lesions; Participants with multiple lacunes or lacunes in a critical memory structure are excluded
* 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 as described in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) within the past 1 year
* Currently treated with medication for obsessive-compulsive disorder or attention deficit disorder
* History of schizophrenia
* History of alcohol or substance abuse or dependence within the past 2 years
* Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
* Clinically significant abnormalities in B12, or TFTs that might interfere with the study
* Residence in skilled nursing facility
* Current use of specific psychoactive medications (e.g.,certain antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.); Current use of warfarin or dabigatran (exclusionary for lumbar puncture).
* Use of investigational agents one month prior to entry and for the duration of the trial
* Participation in clinical studies involving neuropsychological measures being collected more than one time per year
* Exclusion for FDG PET scan and amyloid imaging with Florbetapir F 18: Current or recent participation in any procedures involving radioactive agents such that the total radiation dose exposure to the participant in any given year would exceed the limits of annual and total dose commitment set forth in the US Code of Federal Regulations (CFR) Title 21 Section 361.1.
* Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the protocol director
* Any significant neurologic disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities
* Any significant neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
* Any significant neurologic disease other than Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
* Participants will not be able to participate in FDG PET scan and amyloid imaging with Florbetapir F 18 if the following is true: Current or recent participation in any procedures involving radioactive agents such that the total radiation dose exposure to the participant in any given year would exceed the limits of annual and total dose commitment set forth in the US Code of Federal Regulations (CFR) Title 21 Section 361.1.
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
Alzheimer's Therapeutic Research Institute
OTHER
University of Southern California
OTHER
Responsible Party
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Paul S. Aisen
Professor
Principal Investigators
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Ronald Petersen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Michael W. Weiner, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Paul S. Aisen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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University of Alabama, Birmingham
Birmingham, Alabama, United States
Banner Alzheimer's Institute
Phoenix, Arizona, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
University of California, Irvine
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
Martinez, California, United States
University of California, Irvine (Brain Imaging Center)
Orange, California, United States
Stanford University / PAIRE
Palo Alto, California, United States
University of California, San Francisco
San Francisco, California, 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
Wien Center for Clinical Research
Miami Beach, Florida, United States
USF Health Byrd Alzheimer's Institute
Tampa, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, 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
Boston, Massachusetts, United States
University of Michigan, Ann Arbor
Ann Arbor, Michigan, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
Washington University, St. Louis
St Louis, Missouri, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States
Dartmouth Medical Center
Lebanon, New Hampshire, United States
Albany Medical College
Albany, New York, United States
Dent Neurologic Institute
Amherst, New York, United States
New York University Medical Center
New York, New York, United States
Columbia University
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Nathan S. Kline Institute for Psychiatric Research
Orangeburg, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Case Western Reserve University
Beachwood, 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
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Butler Hospital Memory and Aging Program
Providence, Rhode Island, United States
Roper St. Francis Healthcare
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, Clinic for Alzheimer's Disease and Related Disorders Program
Vancouver, British Columbia, Canada
Parkwood Institute
London, Ontario, Canada
St. Joseph's Health Center - Cognitive Neurology
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
McGill University / Jewish General Hospital Memory Clinic
Montreal, Quebec, Canada
Countries
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References
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Shen L, Kim S, Risacher SL, Nho K, Swaminathan S, West JD, Foroud T, Pankratz N, Moore JH, Sloan CD, Huentelman MJ, Craig DW, Dechairo BM, Potkin SG, Jack CR Jr, Weiner MW, Saykin AJ; Alzheimer's Disease Neuroimaging Initiative. Whole genome association study of brain-wide imaging phenotypes for identifying quantitative trait loci in MCI and AD: A study of the ADNI cohort. Neuroimage. 2010 Nov 15;53(3):1051-63. doi: 10.1016/j.neuroimage.2010.01.042. Epub 2010 Jan 25.
Risacher SL, Saykin AJ, West JD, Shen L, Firpi HA, McDonald BC; Alzheimer's Disease Neuroimaging Initiative (ADNI). Baseline MRI predictors of conversion from MCI to probable AD in the ADNI cohort. Curr Alzheimer Res. 2009 Aug;6(4):347-61. doi: 10.2174/156720509788929273.
Petersen RC, Aisen PS, Beckett LA, Donohue MC, Gamst AC, Harvey DJ, Jack CR Jr, Jagust WJ, Shaw LM, Toga AW, Trojanowski JQ, Weiner MW. Alzheimer's Disease Neuroimaging Initiative (ADNI): clinical characterization. Neurology. 2010 Jan 19;74(3):201-9. doi: 10.1212/WNL.0b013e3181cb3e25. Epub 2009 Dec 30.
Misra C, Fan Y, Davatzikos C. Baseline and longitudinal patterns of brain atrophy in MCI patients, and their use in prediction of short-term conversion to AD: results from ADNI. Neuroimage. 2009 Feb 15;44(4):1415-22. doi: 10.1016/j.neuroimage.2008.10.031. Epub 2008 Nov 5.
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.
Howe MD, Caruso MR, Manoochehri M, Kunicki ZJ, Emrani S, Rudolph JL, Huey ED, Salloway SP, Oh H; Alzheimer's Disease Neuroimaging Initiative. Utility of cerebrovascular imaging biomarkers to detect cerebral amyloidosis. Alzheimers Dement. 2024 Oct;20(10):7220-7231. doi: 10.1002/alz.14207. Epub 2024 Sep 1.
Howe MD, Caruso MR, Manoochehri M, Kunicki ZJ, Emrani S, Rudolph JL, Huey ED, Salloway SP, Oh H; Alzheimer's Disease Neuroimaging Initiative. Utility of cerebrovascular imaging biomarkers to detect cerebral amyloidosis. medRxiv [Preprint]. 2024 May 28:2024.05.28.24308056. doi: 10.1101/2024.05.28.24308056.
Rauchmann BS, Schneider-Axmann T, Perneczky R; Alzheimer's Disease Neuroimaging Initiative (ADNI). Associations of longitudinal plasma p-tau181 and NfL with tau-PET, Abeta-PET and cognition. J Neurol Neurosurg Psychiatry. 2021 Dec;92(12):1289-1295. doi: 10.1136/jnnp-2020-325537. Epub 2021 Jun 29.
Related Links
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Alzheimer's Therapeutic Research Institute
Laboratory of Neuroimaging: Alzheimer's Disease Neuroimaging Initiative
Alzheimer's Disease Neuroimaging Initiative
List of Alzheimer's Disease Neuroimaging Initiative Publications
Other Identifiers
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ADC-039-ADNI2
Identifier Type: -
Identifier Source: org_study_id
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