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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.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 90 Years Both 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
  • 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 Alzheimer’s 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 Alzheimer’s 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 Alzheimer’s 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 Alzheimer’s 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 Alzheimer’s disease), the rate of conversion to MCI or dementia due to Alzheimer’s, 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 Denise Ledlow
205-934-6223
pledlow@uabmc.edu
Banner Alzheimer's Institute Phoenix Arizona 85006 Recruiting Joel Hetelle
602-839-4893
joel.hetelle@bannerhealth.com
Banner Sun Health Research Institute Sun City Arizona 85351 Recruiting Kelly Clark

kelly.clark2@bannerhealth.com
University of California, Irvine Irvine California 92697 Not yet recruiting n/a

University of California, San Diego La Jolla California 92037-1707 Recruiting Helen Vanderswag
858-249-0556
hvanderswag@ucsd.edu
University of Southern California Los Angeles California 90033-5310 Recruiting Nadine Diaz
323-442-7600
nadine.diaz@med.usc.edu
University of California, Los Angeles Los Angeles California 90095 Recruiting Michelle Mather Craig
310-794-6191
mmcraig@mednet.ucla.edu
University of California, Irvine - Neuropsychiatric Center Orange California 92868-3298 Not yet recruiting n/a

Stanford University Palo Alto California 94304 Recruiting Emily Gere
650-852-3287
emilyg@stanford.edu
University of California, San Francisco San Francisco California 94158 Not yet recruiting n/a

University of California, Davis Walnut Creek California 94598-5900 Recruiting Hongzheng Zhang
925-357-6914
hzzhang@ucdavis.edu
Yale University School of Medicine New Haven Connecticut 06510-3330 Recruiting Srinath Ramanan
203-764-6797
srinath.ramanan@yale.edu
Georgetown University Washington District of Columbia 20007-2145 Recruiting Kelly Behan McCann
202-687-0413
keb53@georgetown.edu
Howard University Washington District of Columbia 20060-0001 Not yet recruiting n/a

Mayo Clinic, Jacksonville Jacksonville Florida 32224 Recruiting Sochenda Chea
904-953-3234
chea.sochenda@mayo.edu
Wien Center for Clinical Research Miami Beach Florida 33140-2877 Recruiting Maria Greig-Custo
305-674-2121
maria.greig-custo@msmc.com
University of South Florida - Health Byrd Alzheimer Institute Tampa Florida 33613-4808 Recruiting Jill Smith
813-974-1294
jsmith10@health.usf.edu
Emory University Atlanta Georgia 30322 Recruiting Rebecca Byram
404-712-0195
rbyram@emory.edu
Northwestern University Chicago Illinois 60611-3010 Recruiting Kristine Lipowski
312-503-2486
k-lipowski@northwestern.edu
Rush University Medical Center Chicago Illinois 60612-3806 Recruiting Rita Tharpe
312-563-4721
rita_tharpe@rush.edu
Indiana University Indianapolis Indiana 46202 Recruiting Christina Brown
317-963-7426
chbrown@iupui.edu
University of Iowa Iowa City Iowa 52242 Recruiting Karen Ekstam-Smith
319-353-5158
karen-ekstam@uiowa.edu
University of Kansas Fairway Kansas 66205 Recruiting Melissa Dodd
913-945-7697
mdodd@kumc.edu
University of Kentucky Lexington Kentucky 40504-2681 Recruiting Dorothy Ross
859-323-2737
dross3@email.uky.edu
Johns Hopkins University Baltimore Maryland 21224-2764 Recruiting Daniel D'Agostino
410-502-6161
ddagost1@jhmi.edu
Brigham and Women's Hospital Boston Massachusetts 02115-5804 Recruiting Steve Smith
857-307-5284
ssmith131@partners.org
Boston University Boston Massachusetts 02118 Recruiting Nicole Gullotti
617-414-1077
ngullott@bu.edu
University of Michigan, Ann Arbor Ann Arbor Michigan 48105-2967 Recruiting Jaimie Ziolkowski
734-647-7760
jziolkow@med.umich.edu
Mayo Clinic, Rochester Rochester Minnesota 55905-0001 Recruiting Colleen Albers
507-293-4866
albers.colleen@mayo.edu
Washington University, St. Louis Saint Louis Missouri 63108-2215 Recruiting Maria Carroll
314-286-2683
carrollm@abraxas.wustl.edu
Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas Nevada 89106-0100 Recruiting Jane Bjorklund
855-568-7886
bjorklj@ccf.org
Albany Medical College Albany New York 12208 Recruiting Mary Eglow
518-264-1131
eglowm@mail.amc.edu
Dent Neurologic Institute Buffalo New York 14226-1727 Recruiting Caroline Kumm
716-558-3492
ckumm@dentinstitute.com
New York University Medical Center New York New York 10016-6055 Recruiting Mrunaliniash (Ash) Gaikwad
212-263-5845
mrunaliniash.gaikwad@nyumc.org
Mount Sinai School of Medicine New York New York 10029-6552 Recruiting Jonathan "Yoni" Greenberg
212-659-5621
jonathan.greenberg@mssm.edu
Columbia University New York New York 10032 Recruiting Carlos Perez-Vivaldo
cap2238@cumc.columbia.edu
cap2238@cumc.columbia.edu
Nathan Kline Institute for Psychiatric Research Orangeburg New York 10962-1159 Recruiting Sameh Nossir
201-241-4403
snosir@nki.rfmh.org
University of Rochester Rochester New York 14620 Recruiting Nancy Kowalski
585-760-6569
nancy_kowalski@urmc.rochester.edu
Duke University Medical Center Durham North Carolina 27710 Recruiting Cammie Hellegers
919-681-3986
helle003@mc.duke.edu
Wake Forest University Health Sciences Winston-Salem North Carolina 27157 Recruiting Tim Collare
336-716-6463
rcollare@wakehealth.edu
Case Western Reserve University Beachwood Ohio 44122-4312 Recruiting Parianne Fatica
216-464-6474
parianne.fatica@uhhospitals.org
Ohio State University Columbus Ohio 43210 Recruiting Nicole Vrettos
614-366-8642
nicole.vrettos@osumc.edu
Oregon Health & Science University Portland Oregon 97239-3011 Recruiting Enrica DiMicco
503-494-0976
dimicco@ohsu.edu
University of Pennsylvania Philadelphia Pennsylvania 19104 Recruiting Nayoung Kim
215-746-2559
nayoung.kim@uphs.upenn.edu
University of Pittsburgh Pittsburgh Pennsylvania 15213 Recruiting MaryAnn Oakley
412-692-2721
oakleym@upmc.edu
Rhode Island Hospital Providence Rhode Island 02903 Recruiting Kerstin Calia
401-444-9861
kcalia@lifespan.org
Butler Hospital Memory and Aging Program Providence Rhode Island 02906 Recruiting Tara Tang
401-455-6402
ttang@butler.org
University of Texas, Southwestern MC at Dallas Dallas Texas 75390 Recruiting Kasia Harrah
214-648-9118
kasia.harrah@utsouthwestern.edu
Baylor College of Medicine Houston Texas 77030 Recruiting Nat Pacini
713-798-5328
nat.pacini@bcm.edu
University of Wisconsin Madison Wisconsin 53792-0001 Recruiting Sandra Harding
608-262-4760
sjharding@medicine.wisc.edu
University of British Columbia, Clinic for AD & Related Disorders Vancouver British Columbia V6T 1Z3 Not yet recruiting n/a

Parkwood Hospital London Ontario N6C 0A7 Not yet recruiting n/a

St. Joseph's Health Center - Cognitive Neurology London Ontario N6C 4R3 Not yet recruiting n/a

Sunnybrook Health Sciences Centre Toronto Ontario M4N 3M5 Not yet recruiting n/a

Jewish General Hospital Memory Clinic Montreal Quebec H3T 1E2 Not yet recruiting n/a

Roper St. Francis Charleston South Carolina 29401 Recruiting Allison Lapp
843-724-2214
allison.lapp@rsfh.com
Barrow Neurological Institute Phoenix Arizona 85013 Recruiting George Thomas
602-406-7165
george.thomas@dignityhealth.org

University of Southern California

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

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 Extension Email
ADNI Central Contact 888-223-6495

Alzheimer`s Disease Neuroimaging Initiative 3 (ADNI3) Protocol