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Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3)

Recruiting

The purpose of this observational study is to determine the relationships among clinical, cognitive, imaging, genetic, and biomarker characteristics of the entire spectrum of Alzheimer's disease as it progresses from a preclinical stage to very mild symptoms to mild cognitive impairment (MCI) to dementia. Participants sought include those with normal cognition, MCI, or mild Alzheimer's dementia (currently recruiting non-Caucasian participants only for the normal cognition group).

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 90 Years All Yes
October 2016
October 2021
2000

All New Participants

  • Good general health
  • Study partner who has frequent contact with participant (minimum average of 10 hours per week) and can accompany participant to clinic visits
  • Modified Hachinski Ischemic Score of less than or equal to 4; Geriatric Depression Scale score of less than 6
  • Completion of six grades of education or good work history 
  • Willing to undergo repeated MRIs, at least two PET scans, blood collection, and at least one lumbar puncture 
  • Willing to share genetic data and biomarker samples
  • Fluent in English or Spanish

Cognitively Normal Participants

  • Cognitively normal, based on absence of significant impairment in cognitive function or activities of daily living (currently recruiting non-Caucasian participants only for the normal cognition group)
  • With or without subjective memory complaints 
  • Normal memory function score; Mini-Mental State Examination (MMSE) score of 24-30 (exceptions considered for less than 8 years of education); Clinical Dementia Rating of 0; Memory Box score of 0

Participants with MCI

  • Subjective memory concern reported by participant, study partner, or clinician
  • Abnormal memory function score; MMSE score of 24-30 (exceptions considered for less than 8 years of education); Clinical Dementia Rating of 0.5; Memory Box score of at least 0.5
  • General cognition and functional performance such that a diagnosis of Alzheimer's disease cannot be made by the site physician
  • Permitted medications if taking at least 4 weeks: stable dose of antidepressants lacking significant anticholinergic effects, cholinesterase inhibitors or memantine, estrogen replacement therapy, gingko biloba; must discontinue psychoactive medications at least 4 weeks before screening

Participants with Alzheimers Disease

  • Subjective memory concern reported by participant, study partner, or clinician
  • Abnormal memory function score; MMSE score of 20-24 (exceptions considered for less than 8 years of education); Clinical Dementia Rating of 0.5 or 1.0
  • Meets criteria for probable Alzheimers disease
  • Permitted medications if taking at least 4 weeks: same as for MCI above

  • Significant neurological 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 neurological deficits or known structural brain abnormalities
  • Screening/baseline MRI brain scan with evidence of infection, infarction or other focal lesions, or multiple lacunes or lacunes in a critical memory structure
  • Contraindications to MRI including pacemaker or metal fragments or foreign objects in the eyes, skin, or body
  • Major depression or bipolar disorder within the past year; psychotic features, agitation, or behavioral problems within the last 3 months; history of schizophrenia
  • Current treatment for obsessive-compulsive disorder or attention deficit disorder
  • Alcohol or substance abuse/dependence within the past 2 years
  • Any significant systemic illness or unstable medical condition that could lead to difficulty participating in the study
  • Pregnant, lactating, or of childbearing potential (women must be 2 years postmenopausal or surgically sterile)
  • Clinically significant abnormalities in B12 or thyroid function tests
  • Prohibited medications: psychoactive medications (certain antidepressants, neuroleptics, chronic anxiolytics, or sedative hypnotics); warfarin or other anticoagulants (such as dabigatran, rivaroxaban, and apixaban); investigational agents 1 month prior to entry and during the study
  • Residence in skilled nursing facility
  • Participation in clinical studies involving neuropsychological measures collected more than one time per year

ADNI3 extends the work of previous studies, first launched in 2004, to inform the design of therapeutic trials in Alzheimers disease. ADNI3 will continue ADNI's goals to identify diagnostic and prognostic markers of disease, identify outcome measures that can be used in clinical trials, and help develop the most effective clinical trials.

Up to 1,200 new participants are being sought for ADNI3. Clinical, cognitive, imaging, biomarker, and genetic characteristics will be assessed across three groups of participants: cognitively normal, MCI, and mild Alzheimers dementia. Investigators will evaluate changes in participants' cognition (including memory, reasoning, and language). Participants will undergo clinical, cognitive, and genetic tests, as well as positron emission tomography (PET) and magnetic resonance imaging (MRI) scans and cerebrospinal fluid collection for up to 5 years.

Investigators will also assess changes in brain structure, amyloid and tau deposits in the brain (two hallmarks of Alzheimers disease), the rate of conversion to MCI or dementia due to Alzheimers, and changes in glucose metabolism and tau biomarkers in cerebrospinal fluid.

To find out more information about the ADNI3 study, please visit www.ADNI3.org.

Name City State Zip Status Primary Contact
University of Alabama, Birmingham
Birmingham Alabama 35294 Recruiting Jackie Vaughn
205-996-3679
jhvaughn@uabmc.edu
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Banner Alzheimer's Institute
Phoenix Arizona 85006 Recruiting Chanti Smith
602-839-4617
Chanti.Smith@bannerhealth.com
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Barrow Neurological Institute
Phoenix Arizona 85013 Recruiting Angelica Garcia

angelica.garcia@dignityhealth.org
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Banner Sun Health Research Institute
Sun City Arizona 85351 Recruiting Kelly Clark
623-832-6527
Kelly.Clark2@bannerhealth.com
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University of California, Irvine
Irvine California 92697 Recruiting Beatriz Yañez
949-824-3250
byanez@uci.edu
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University of California, San Diego
La Jolla California 92037 Recruiting Mollie Paster
858-249-1329
mrpaster@ucsd.edu
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Long Beach VA Neuropsychiatric Research Program
Long Beach California 90822 Recruiting Sakineh (Parvin) Khalaghizadeh
562-826-8000
sakineh.khalaghizadeh@va.gov
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University of Southern California
Los Angeles California 90033 Recruiting Nadine Diaz
323-442-7600
Nadine.Diaz@med.usc.edu
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University of California, Los Angeles
Los Angeles California 90095 Recruiting Celine Ossinalde
310-794-6191
cossinalde@mednet.ucla.edu
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Stanford University
Palo Alto California 94304 Recruiting Jessica White

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University of California, San Francisco
San Francisco California 94158 Recruiting Victoria Brown
415-514-8745
victoria.brown@ucsf.edu
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University of California, Davis
Walnut Creek California 94598 Recruiting Hongzheng Zhang
925-357-6914
hzzhang@ucdavis.edu
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Yale University School of Medicine
New Haven Connecticut 06510 Recruiting Srinath Ramanan
203-764-6797
srinath.ramanan@yale.edu
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Georgetown University
Washington District of Columbia 20007 Recruiting Kelly McCann
202-687-0413
keb53@georgetown.edu
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Howard University
Washington District of Columbia 20060 Recruiting Saba Wolday
202-865-7895
swolday@howard.edu
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Mayo Clinic, Jacksonville
Jacksonville Florida 32224 Recruiting Sochenda Chea
904-953-3234
chea.sochenda@mayo.edu
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Wien Center for Clinical Research
Miami Beach Florida 33140 Recruiting Maria Greig-Custo
305-674-2121
Maria.Greig-Custo@msmc.com
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University of South Florida - Health Byrd Alzheimer Institute
Tampa Florida 33613 Recruiting Juris Janavs
813-396-0637
jjanavs@health.usf.edu
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Emory University
Atlanta Georgia 30322 Recruiting Rebecca Byram
404-712-0195
rbyram@emory.edu
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Northwestern University
Chicago Illinois 60611 Recruiting Kristine Lipowski
312-503-2486
k-lipowski@northwestern.edu
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Rush University Medical Center
Chicago Illinois 60612 Recruiting Erin Yurko
312-942-6596
erin_yurko@rush.edu
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Indiana University
Indianapolis Indiana 46202 Recruiting Christina Brown
317-963-7426
chbrown@iupui.edu
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University of Iowa
Iowa City Iowa 52242 Recruiting Karen Ekstam-Smith
319-353-5158
karen-ekstam@uiowa.edu
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University of Kansas
Fairway Kansas 66205 Recruiting Melissa Dodd
913-945-6792
mdodd@kumc.edu
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University of Kentucky
Lexington Kentucky 40504 Recruiting Dorothy Ross
859-323-2737
dross3@email.uky.edu
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Johns Hopkins University
Baltimore Maryland 21224 Recruiting Scott Rudow
443-287-0381
srudow2@jhmi.edu
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Brigham and Women's Hospital
Boston Massachusetts 02115-5804 Recruiting Nancy Coppelman
617-732-8085
ncoppelman@partners.org
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Boston University
Boston Massachusetts 02118 Recruiting Nicole Gullotti
617-414-1077
ngullott@bu.edu
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University of Michigan, Ann Arbor
Ann Arbor Michigan 48105 Recruiting Lisa Zbizek-Nulph
734-232-1199
lzbizek@med.umich.edu
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Washington University, St. Louis
Saint Louis Missouri 63108 Recruiting David Winkfield
314-286-2429
davidwinkfield@wustl.edu
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Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas Nevada 89106 Recruiting Jennifer Hawse
702-701-7967
HAWSEJ@ccf.org
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Albany Medical College
Albany New York 12208 Recruiting Mary Eglow
518-264-1130
eglowm@mail.amc.edu
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Dent Neurologic Institute
Buffalo New York 14226 Recruiting Caroline Kumm
716-558-3492
ckumm@dentinstitute.com
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New York University Medical Center
New York New York 10016 Recruiting Anaztasia Ulysse
212-263-0771
Anaztasia.Ulysse@nyumc.org
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Mount Sinai School of Medicine
New York New York 10029 Recruiting Jonathan "Yoni" Greenberg
212-659-5621
jonathan.greenberg@mssm.edu
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Columbia University
New York New York 10032 Recruiting Anton Kociolek
212-342-0522
ak3951@cumc.columbia.edu
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Nathan Kline Institute for Psychiatric Research
Orangeburg New York 10962 Recruiting Antero Sarreal
845-398-6532
asarreal@nki.rfmh.org
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University of Rochester
Rochester New York 14620 Recruiting Nancy Kowalski
585-760-6569
nancy_kowalski@urmc.rochester.edu
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Duke University Medical Center
Durham North Carolina 27710 Recruiting Cammie Hellegers
919-681-3986
caroline.hellegers@duke.edu
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Wake Forest University Health Sciences
Winston-Salem North Carolina 27157 Recruiting Taylor Dannemiller

tdannemi@wakehealth.edu
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Case Western Reserve University
Beachwood Ohio 44122 Recruiting Parianne Fatica
216-464-6474
parianne.fatica@uhhospitals.org
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Ohio State University
Columbus Ohio 43210 Recruiting Jennifer Icenhour
614-293-6882
jennifer.icenhour@osumc.edu
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Oregon Health and Science University
Portland Oregon 97239 Recruiting Rachel Crissey
503-494-0976
crissey@ohsu.edu
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University of Pennsylvania
Philadelphia Pennsylvania 19104 Recruiting Jessica Nunez-Lopez
215-662-4379
Jessica.Nunez@uphs.upenn.edu
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University of Pittsburgh
Pittsburgh Pennsylvania 15213 Recruiting MaryAnn Oakley
412-692-2721
oakleym@upmc.edu
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Rhode Island Hospital
Providence Rhode Island 02903 Recruiting Terry Fogerty
401-606-4664
TFogerty@lifespan.org
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Butler Hospital Memory and Aging Program
Providence Rhode Island 02906 Recruiting Tara Tang
401-455-6403
TTang@Butler.org
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Roper St. Francis
Charleston South Carolina 29401 Recruiting Allison Lapp
843-724-2214
allison.lapp@rsfh.com
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Vanderbilt University
Nashville Tennessee 37235 Recruiting KaTerri Kelly
615-875-0955
katerri.m.kelly@vumc.org
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University of Texas, Southwestern MC at Dallas
Dallas Texas 75390 Recruiting Sarah Brisebois
214-648-9331
sarah.brisebois@UTSouthwestern.edu
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Baylor College of Medicine
Houston Texas 77030 Recruiting Nat Pacini
713-798-5328
nat.pacini@bcm.edu
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Houston Methodist
Houston Texas 77030 Recruiting Jennifer Garrett
713-441-9484
jmgarrett@houstonmethodist.org
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University of Wisconsin
Madison Wisconsin 53792 Recruiting Sandra Harding
608-262-4760
sjharding@medicine.wisc.edu
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University of British Columbia, Clinic for AD & Related
Vancouver British Columbia V6T 1Z3 Recruiting Benita Mudge
604-822-7990
benita.mudge@vch.ca
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Parkwood Institute
London Ontario N6C 0A7 Recruiting Charlene Bartha
519-685-4292
Charlene.Bartha@sjhc.london.on.ca
St. Joseph's Health Center - Cognitive Neurology
London Ontario N6C 4R3 Recruiting Charlene Bartha
519-685-4292
Charlene.Bartha@sjhc.london.on.ca
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Sunnybrook Health Sciences Centre
Toronto Ontario M4N 3M5 Recruiting Maryna Butenko
416-480-6100
maryna.butenko@sunnybrook.ca
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McGill University /Jewish General Hospital Memory Clinic
Montreal Quebec H3T 1E2 Recruiting Chris Hosein
514-340-8222
chosein@jgh.mcgill.ca
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University of Southern California

  • Northern California Institute of Research and Education
  • National Institute on Aging (NIA)
  • Alzheimer's Therapeutic Research Institute

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

Name Phone Email
ADNI Central Contact 888-223-6495 adni3-participate@usc.edu

NCT02854033

Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3) Protocol