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Alzheimer's Disease Neuroimaging Initiative 2 (ADNI2)

Active, not recruiting

The purpose of ADNI2 is to examine how brain imaging and other biomarkers can be used to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease. Together with previous studies ADNI1 and ADNI-GO, ADNI2 seeks to determine the relationships among brain imaging results, biomarkers, and clinical, cognitive, and genetic characteristics of the entire spectrum of Alzheimer's as it evolves from normal aging through dementia. The overall goals are increased knowledge concerning the sequence and timing of events leading to MCI and Alzheimer's disease, better methods for early detection of these conditions, and data that informs clinical trials aimed at slowing disease progression.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 90 Years Both Accepts Healthy Volunteers
January 2011
October 2018
650

All Participants

  • Age 55-90, with a minimum age of 65 for the normal control group and the significant memory concern group
  • Study partner who has frequent contact with the participant (an average of 10 hours per week or more) and can accompany the participant to all clinic visits
  • Seeing and hearing ability adequate for neuropsychological testing
  • Good general health
  • Participant is not pregnant, lactating, or of childbearing potential (women must be 2 years postmenopausal or surgically sterile)
  • Six grades of education or a good work history (sufficient to exclude mental retardation)
  • Must speak English or Spanish fluently
  • No medical contraindications to MRI
  • Stability of permitted medications for 4 weeks; in particular, participants may take antidepressants lacking significant anticholinergic side effects, estrogen replacement therapy, gingko biloba (permissible but discouraged); washout from psychoactive medication for at least 4 weeks prior to screening
  • Hachinski score of less than or equal to 4; Geriatric Depression Scale less than 6

Cognitively Normal Participants

  • Free of memory complaints
  • Normal memory function score on Wechsler Memory Scale; Mini-Mental State Exam (MMSE) score of 24-30; Clinical Dementia Rating (CDR) = 0; Memory Box score = 0
  • Cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living

Signicant Memory Concern Participants

  • Significant subjective memory concern as reported by subject, study partner, or clinician and confirmed by Cognitive Change Index of 16
  • Normal memory function score on Wechsler Memory Scale (adjusted for education); Mini-Mental State Exam (MMSE) score of 24-30; Clinical Dementia Rating (CDR) = 0; Memory Box score = 0
  • Cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living
  • Medications permitted if stable for 4 weeks, including: antidepressants lacking significant anticholinergic side effects, estrogen replacement therapy, gingko biloba (permissible but discouraged); washout from psychoactive medication (such as excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics) for at least 4 weeks prior to screening

EMCI and LMCI Participants

  • Subjective memory concern as reported by participant, study partner, or clinician
  • Abnormal memory function score on Wechsler Memory Scale; Mini-Mental State Exam (MMSE) score of 24-30; Clinical Dementia Rating (CDR) = 0.5; Memory Box score = 0.5 or higher
  • General cognition and functional performance such that a diagnosis of AD cannot be made by the site physician
  • Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to screening

Alzheimer's Disease Participants

  • Subjective memory concern as reported by subject, study partner, or clinician
  • Abnormal memory function score on Wechsler Memory Scale; Mini-Mental State Exam (MMSE) score of 20-26; Clinical Dementia Rating (CDR) = 0.5 or 1.0
  • Meets criteria for probable Alzheimer's disease
  • Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to screening

Follow-up Participants from ADNI1 and ADNI-GO

  • Must have been enrolled and followed in ADNI1 for at least one year or enrolled in ADNI-GO with original diagnosis of cognitively normal, MCI, or EMCI regardless of whether a diagnostic conversion has occurred since initial enrollment in ADNI
  • Willing and able to continue to participate; a reduced battery of tests is allowable if the subject 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

  • Screening/baseline MRI scan with evidence of infection, infarction, or other focal lesions; subjects 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 or bipolar disorder
  • History of schizophrenia, alcohol or substance abuse or dependence within the past 2 years, or any significant illness or unstable medical condition that could lead to difficulty complying with the protocol
  • Residence in skilled nursing facility
  • Participation in clinical studies involving neuropsychological measures collected more than one time per year
  • Current or recent participation in any procedures involving radioactive agents such that the total radiation dose exposure would exceed allowable limits
  • Prohibited medications: Current use of specific psychoactive medications (such as certain antidepressants, neuroleptics, chronic anxiolytics, or sedative hypnotics), warfarin or dabigatran (exclusionary for lumbar puncture), medication for obsessive-compulsive disorder or attention deficit disorder; use of investigational agents one month prior to entry and for the duration of the study
  • Significant neurologic disease as follows:
    • Normal controls and significant memory concern participants: conditions including 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
    • EMCI and LMCI participants: significant neurologic disease other than suspected incipient Alzheimer's, including any conditions listed above for normal controls
    • Alzheimer's disease participants: diseases other than Alzheimer's including those listed above for normal controls
    • Follow-up participants from ADNI1 and ADNI GO: participants will not be able to participate in amyloid imaging with Florbetapir F 18 if they have had any procedures involving radioactive agents such that the total radiation dose exposure to the participant in any given year would exceed federal limits.

The Alzheimer's Disease Neuroimaging Initiative (ADNI) began in October 2004 as a landmark public-private study that gathered and analyzed thousands of brain scans, genetic profiles, and biomarkers in blood and cerebrospinal fluid. The original goal was to define biomarkers that would best measure the effects of treating Alzheimer's disease in clinical trials. The goal has since been expanded to using biomarkers to identify Alzheimer's at a predementia stage.

Leading-edge technologies under study include brain-imaging techniques such as positron emission tomography (PET) and structural MRI. PET technologies include FDG-PET, which measures glucose metabolism in the brain, and PET using the radioactive compound Florbetapir F 18, which measures beta-amyloid in the brain. These imaging technologies reveal how the brain's structure and function change as Alzheimer's starts and progresses. Biomarkers in cerebrospinal fluid show other changes that could identify which patients with MCI will develop Alzheimer's. 

ADNI2 extends the work of two previous studies, ADNI1 and ADNI-GO, to understand the progression of Alzheimer's disease from its earliest stages. The overall goal is to determine the relationships among the clinical, cognitive, imaging, genetic, and biochemical biomarker characteristics of the entire spectrum of Alzheimer's, 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 Alzheimer's, development of better clinical and biomarker methods for early detection and for monitoring the progression of these conditions, and facilitation of clinical trials to slow disease progressionultimately contributing to the prevention of Alzheimer's disease.

Name City State Zip Status Primary Contact
University of Alabama, Birmingham
Birmingham Alabama 35294

Banner Alzheimer's Institute
Phoenix Arizona 85006

Banner Sun Health Research Institute
Sun City Arizona 85351

University of California, Irvine
Irvine California 92697

University of California, San Diego
La Jolla California 92037

University of Southern California
Los Angeles California 90033

University of California, Los Angeles
Los Angeles California 90095

University of California, Davis
Martinez California 94553

University of California, Irvine (Brain Imaging Center)
Orange California 92868

Stanford University / PAIRE
Palo Alto California 94304

University of California, San Francisco
San Francisco California 94158

Yale University School of Medicine
New Haven Connecticut 06510

Georgetown University
Washington District of Columbia 20057

Howard University
Washington District of Columbia 20060

Mayo Clinic, Jacksonville
Jacksonville Florida 32224

Wien Center for Clinical Research
Miami Beach Florida 33140

USF Health Byrd Alzheimer's Institute
Tampa Florida 33613

Premiere Research Institute
West Palm Beach Florida 33407

Emory University
Atlanta Georgia 30329

Northwestern University
Chicago Illinois 60611

Rush University Medical Center
Chicago Illinois 60612

Indiana University
Indianapolis Indiana 46202

University of Iowa
Iowa City Iowa 52242

University of Kansas
Kansas City Kansas 66160

University of Kentucky
Lexington Kentucky 40536

Johns Hopkins University
Baltimore Maryland 21205

Brigham and Women's Hospital
Boston Massachusetts 02115

Boston University
Boston Massachusetts 02118

University of Michigan, Ann Arbor
Ann Arbor Michigan 48109

Mayo Clinic, Rochester
Rochester Minnesota 55901

Washington University, St. Louis
Saint Louis Missouri 63108

Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas Nevada 89106

Dartmouth Medical Center
Lebanon New Hampshire 03756

Albany Medical College
Albany New York 12208

Dent Neurologic Institute
Amherst New York 14226

New York University Medical Center
New York New York 10016

Columbia University
New York New York 10032

Mount Sinai School of Medicine
New York New York 10032

Nathan S. Kline Institute for Psychiatric Research
Orangeburg New York 10962

University of Rochester Medical Center
Rochester New York 14620

Duke University Medical Center
Durham North Carolina 27710

Wake Forest University Health Sciences
Winston-Salem North Carolina 27157

Case Western Reserve University
Beachwood Ohio 44122

Ohio State University
Columbus Ohio 43210

Oregon Health and Science University
Portland Oregon 97239

University of Pennsylvania
Philadelphia Pennsylvania 19104

University of Pittsburgh
Pittsburgh Pennsylvania 15213

Rhode Island Hospital
Providence Rhode Island 02903

Butler Hospital Memory and Aging Program
Providence Rhode Island 02906

Roper St. Francis Healthcare
North Charleston South Carolina 29406

University of Texas Southwestern Medical Center
Dallas Texas 75390

Baylor College of Medicine
Houston Texas 77030

University of Wisconsin
Madison Wisconsin 53705

University of British Columbia, Clinic for Alzheimer's Disease and Related Disorders Program
Vancouver British Columbia V6T 2B5

Parkwood Institute
London Ontario N6C 5J1

St. Joseph's Health Center - Cognitive Neurology
London Ontario N6C 5J1

Sunnybrook Health Sciences Centre
Toronto Ontario M4N 3M5

McGill University / Jewish General Hospital Memory Clinic
Montreal Quebec H3T 1E2

University of Southern California, Alzheimer's Therapeutic Research Institute

  • Northern California Institute for Research and Education (NCIRE)
  • National Institute on Aging (NIA)

Name Role Affiliation
Ronald Petersen, MD, PhD Principal Investigator Mayo Clinic
Michael W. Weiner, MD Principal Investigator University of California, San Francisco
Paul S. Aisen, MD Principal Investigator University of Southern California, Alzheimer's Therapeutic Research Institute

Name Phone Email
Shelley Moore 858-964-0809 shelleym@usc.edu
Karen Bowman 858-964-0828 k.bowman@usc.edu

NCT01231971

Alzheimer's Disease Neuroimaging Initiative 2