Alzheimer's Disease Education and Referral Center

Alzheimer's Disease Neuroimaging Initiative 2 (ADNI2)

Alzheimer's Disease Neuroimaging Initiative 2 (ADNI2)

Overall Status: 
No longer recruiting
Brief Description: 

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.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
55 Years
90 Years
Both
Accepts Healthy Volunteers
Inclusion Criteria: 

    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
Exclusion Criteria: 
    • 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.
Detailed Description: 

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 progression—ultimately contributing to the prevention of Alzheimer's disease.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.5075555, -86.8093239

University of Alabama
Birmingham
Alabama
35294
Recruiting
Denise Ledlow
205-934-6223
pdledlow@uab.edu

Geolocation is 33.4636012, -112.0535987

Banner Alzheimer's Institute
Phoenix
Arizona
85006
Recruiting
Stephanie Reeder
602-839-6279
stephanie.reeder@bannerhealth.com

Geolocation is 33.612697, -112.280129

Banner Sun Health Research Institute
Sun City
Arizona
85351
Recruiting
Sherye Sirrel
623-875-6522
sherye.sirrel@bannerhealth.com

Geolocation is 33.6471239, -117.8421325

University of California, Irvine
Irvine
California
92697
Recruiting
Catherine McAdams-Ortiz
949-824-8726
cmcadams@uci.edu

Geolocation is 32.8283259, -117.255854

University of California, San Diego
La Jolla
California
92037
Recruiting
Helen Vanderswag
858-246-1245
hvanderswag@ucsd.edu

Geolocation is 34.070264, -118.4440562

University of California, Los Angeles
Los Angeles
California
90095
Recruiting
Jennifer Eastman
310-794-3244
jeastman@mednet.ucla.edu

Geolocation is 34.0502898, -118.2117257

University of Southern California
Los Angeles
California
90033
Recruiting
Mauricio Becerra
323-442-7594
mjbecerr@usc.edu

Geolocation is 37.9873593, -122.151897

University of California, Davis
Martinez
California
94553
Recruiting
Katharine Vieira
925-372-2485
kevieira@ucdavis.edu

Geolocation is 33.78659, -117.8750976

University of California, Irvine
Orange
California
92868
Recruiting
Nicholas Vu
714-456-7994
nqvu@hs.uci.edu

Geolocation is 37.3813444, -122.1802812

Stanford University
Palo Alto
California
94304
Recruiting
Michael Nolasco
650-849-0491
michael.nolasco@va.gov

Geolocation is 37.7748363, -122.3872576

University of California, San Francisco
San Francisco
California
94158
Recruiting
Josiah Leong
415-502-7149
jleong@memory.ucsf.edu

Geolocation is 41.3052226, -72.9268626

Yale University
New Haven
Connecticut
06510
Recruiting
Martha MacAvoy
203-764-8100
martha.macavoy@yale.edu

Geolocation is 38.9079086, -77.0716829

Georgetown University
Washington
District of Columbia
20057
Recruiting
Kelly Behan
202-687-0413
keb53@georgetown.edu

Geolocation is 38.9178427, -77.0218255

Howard University
Washington
District of Columbia
20060
Recruiting
Saba Wolday
202-865-7895
swolday@howard.edu

Geolocation is 30.2606613, -81.460856

Mayo Clinic
Jacksonville
Florida
32224
Recruiting
Tracy Kendall
904-953-7989
kendall.tracy@mayo.edu

Geolocation is 25.7138002, -80.1596041

Wien Center for Clinical Research
Miami Beach
Florida
33149
Recruiting
Maria Greig-Custo
305-674-2121 x54480
maria.greig-custo@msmc.com

Geolocation is 28.0869646, -82.4698603

Univeristy of South Florida/Byrd Alzheimer Institute
Tampa
Florida
33613
Recruiting
Jill Ardila
813-974-4355
jardila1@health.usf.edu

Geolocation is 26.7619563, -80.1037721

Premiere Research Institute
West Palm Beach
Florida
33407
Recruiting
Teresa Villena
561-845-0500
tvillena@aol.com

Geolocation is 33.828105, -84.3279093

Emory University
Atlanta
Georgia
30329
Recruiting
Lavezza Zanders
404-728-6544
lzander@emory.edu

Geolocation is 41.8816606, -87.6926257

Rush University Medical Center
Chicago
Illinois
60612
Recruiting
Patricia Samuels
312-942-3033
patricia_samuels@rush.edu

Geolocation is 41.8925085, -87.6161696

Northwestern University
Chicago
Illinois
60611
Recruiting
Kristine Lipowski
312-503-2486
k-lipowski@northwestern.edu

Geolocation is 39.7794767, -86.1700894

Indiana University
Indianapolis
Indiana
46202
Recruiting
Scott Herring
317-274-9903
sherring@iupui.edu

Geolocation is 41.659363, -91.5487099

University of Iowa
Iowa City
Iowa
52242
Recruiting
Karen Ekstam-Smith
319-353-5158
karen-ekstam@uiowa.edu

Geolocation is 39.0313154, -94.6347041

University of Kansas
Fairway
Kansas
66205
Recruiting
Rebecca Bothwell
913-945-5033
rbothwell@kumc.edu

Geolocation is 38.0328237, -84.5067424

University of Kentucky
Lexington
Kentucky
40536
Recruiting
Barbara Martin
859-323-0494
barbara.martin@uky.edu

Geolocation is 39.3042055, -76.557493

Johns Hopkins University
Baltimore
Maryland
21205
Recruiting
Daniel D'Agostino
410-502-6161
ddagost1@jhmi.edu

Geolocation is 42.339904, -71.0898892

Brigham and Women's Hospital
Boston
Massachusetts
02115
Recruiting
Natacha Lorius
617-643-0147
nlorius@partners.org

Geolocation is 42.3377967, -71.0705763

Boston University
Boston
Massachusetts
02118
Recruiting
Meenakshi Chivukula
617-638-8390
mvc2010@bu.edu

Geolocation is 42.3295957, -83.7092861

University of Michigan
Ann Arbor
Michigan
48105
Recruiting
Joanne Lord
734-647-7760
jllord@umich.edu

Geolocation is 44.0780552, -92.5098914

Mayo Clinic
Rochester
Minnesota
55901
Recruiting
Kris Johnson
507-284-6407
johnson.kris@mayo.edu

Geolocation is 38.647459, -90.25731

Washington University
St. Louis
Missouri
63108
Recruiting
Maria Carroll
314-286-0246
carrollm@abaxas.wustl.edu

Geolocation is 36.1922841, -115.1592718

Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas
Nevada
89106
Recruiting
Michelle Sholar
702-483-6026
sholarm@ccf.org

Geolocation is 43.64, -72.25

Dartmouth Medical Center
Lebanon
New Hampshire
03756
Recruiting
Tamar Kitzmiller
603-650-5811
Tamar.J.Kitzmiller@hitchcock.org

Geolocation is 42.6547387, -73.7889689

Albany Medical College
Albany
New York
12208
Recruiting
Paula Malone
518-262-0809
malonep@mail.amc.edu

Geolocation is 42.9674726, -78.7986181

Dent Neurologic Institute
Amherst
New York
14226
Recruiting
Michelle Rainka
716-250-2038
mrainka@dentinstitute.com

Geolocation is 40.74727, -73.9800645

New York University Medical Center
New York
New York
10016
Recruiting
Dana Pogorelec
212-263-5708
dana.pogorelec@nyumc.org

Geolocation is 40.8409822, -73.9447994

Columbia University
New York
New York
10032
Recruiting
Philip Yeung
212-342-0522
PMY2101@columbia.edu

Geolocation is 40.7916407, -73.9447994

Mount Sinai School of Medicine
New York
New York
10029
Recruiting
Cleopatra McGovern
212-241-1514
cleopatra.mcgovern@mssm.edu

Geolocation is 41.0481178, -73.9301037

Nathan Kline Institute for Psychiatric Research
Orangeburg
New York
10962
Recruiting
Vita Pomara
845-398-5582
vpomara@nki.rfmh.org

Geolocation is 43.1301942, -77.6020569

University of Rochester Medical Center
Rochester
New York
14620
Recruiting
Bonnie Goldstein
585-760-6561
bonnies_goldstein@urmc.rochester.edu

Geolocation is 36.0038131, -78.9387241

Duke University Medical Center
Durham
North Carolina
27710
Recruiting
Cammie Hellegers
919-681-3986
helle003@mc.duke.edu

Geolocation is 36.0906568, -80.2715385

Wake Forest University
Winston-Salem
North Carolina
27157
Recruiting
Leslie Gordineer
336-713-8477
lgordine@wfubmc.edu

Geolocation is 41.4766201, -81.5047772

Case Western Reserve University
Beachwood
Ohio
44122
Recruiting
Parianne Fatica
216-464-6474
parianne.fatica@uhhospitals.org

Geolocation is 39.9990626, -83.0173386

Ohio State University
Columbus
Ohio
43210
Recruiting
Jennifer Icenhour
614-293-6882
jennifer.icenhour@osumc.edu

Geolocation is 45.4874111, -122.6875541

Oregon Health & Science University
Portland
Oregon
97239
Recruiting
Betty Lind
503-494-9399
petriko@ohsu.edu

Geolocation is 39.9583587, -75.1953934

University of Pennsylvania
Philadelphia
Pennsylvania
19104
Recruiting
Jessica Nunez-Lopez
215-662-4379
jessica.nunez@uphs.upenn.edu

Geolocation is 40.4379259, -79.9556424

University of Pittsburgh
Pittsburgh
Pennsylvania
15213
Recruiting
MaryAnn Oakley
412-692-2721
oakleym@upmc.edu

Geolocation is 41.816736, -71.4091563

Rhode Island Hospital
Providence
Rhode Island
02903
Recruiting
Dana Ayoub
401-444-7691
dayoub@lifespan.org

Geolocation is 41.8396817, -71.3883751

Butler Hospital Memory and Aging Program
Providence
Rhode Island
02906
Recruiting
Morgan Brescia
401-455-6403
mbrescia@butler.org

Geolocation is 32.9221152, -80.0367259

Medical University of South Carolina
North Charleston
South Carolina
29406
Recruiting
Arthur Williams
843-740-1592
alwpoe@musc.edu

Geolocation is 32.8113367, -96.8397899

University of Texas Southwestern Medical Center
Dallas
Texas
75390
Recruiting
Kristin Martin-Cook
214-648-9368
kristin.martin-cook@utsouthwestern.edu

Geolocation is 29.7050857, -95.4018087

Baylor College of Medicine
Houston
Texas
77030
Recruiting
Munir Chowdhury
713-798-4734
munirc@bcm.edu

Geolocation is 43.0772547, -89.430773

University of Wisconsin
Madison
Wisconsin
53792
Recruiting
Sandra Harding
608-262-4760
sjharding@medicine.wisc.edu

Geolocation is 49.2650543, -123.2459921

Univeristy of British Columbia
Vancouver
British Columbia
V6T 2B5
Recruiting
Benita Mudge
604-822-7990
benita.mudge@vch.ca

Geolocation is 42.9555117, -81.2257216

Parkwood Hospital
London
Ontario
N6C 5J1
Recruiting
Brittany Lloyd
519-685-4292 x42255
brittany.lloyd@sjhc.london.on.ca

Geolocation is 42.9873445, -81.2508077

St. Joseph's Health Center
London
Ontario
N6A 4V2
Recruiting
Brittany Lloyd
519-685-4292 x42255
brittany.lloyd@sjhc.london.on.ca

Geolocation is 43.7215696, -79.3768256

Sunnybrooke Health Sciences Centre
Toronto
Ontario
M4N 3M5
Recruiting
Joanne Lawrence
416-480-6108
joanne.lawrence@sunnybrook.ca

Geolocation is 45.4976084, -73.6292768

McGill University/Jewish General Hospital
Montreal
Quebec
H3T 1E2
Recruiting
Chris Hosein
514-340-8222 x3621
chosein@jgh.mcgill.ca

Geolocation is 40.7700703, -73.9580246

Weill Cornell Memory Disorders Program
New York
New York
10021
Recruiting
Errin Hibbard
212-746-7826
erh2009@med.cornell.edu
Lead Sponsor: 
Agency
Alzheimer's Disease Cooperative Study (ADCS)
Collaborator Sponsor: 
Agency
Northern California Institute for Research and Education (NCIRE)
National Institute on Aging (NIA)
Facility Investigators: 
NameRoleAffiliation
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 California, San Diego
Study Contact: 
NamePhoneEmail
Jeffree Itrich
858-246-1317
Locations
 
 
ClinicalTrials.gov ID 
Official Title: 
Alzheimer's Disease Neuroimaging Initiative 2
Study Start Date: 
January 2011
Study End Date: 
January 2016
Disease Stage: 
Pre-clinical
Early
Enrollment: 
650