Alzheimer's Disease Education and Referral Center

Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3)

Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3)

Overall Status: 
Recruiting
Brief Description: 

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.

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

    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
Exclusion Criteria: 
    • 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
Detailed Description: 

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.

Central Contact Information: 

For more information about this clinical trial or study sites, please call 888-223-6495. To be notified when a research site near you begins recruiting, please fill out this registery form.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.5075555, -86.8093239

University of Alabama, Birmingham
Birmingham
Alabama
35294
Recruiting
Denise Ledlow
205-934-6223
pledlow@uabmc.edu

Geolocation is 33.4636012, -112.0535987

Banner Alzheimer's Institute
Phoenix
Arizona
85006
Recruiting
Joel Hetelle
602-839-4893
joel.hetelle@bannerhealth.com

Geolocation is 33.6020658, -112.280129

Banner Sun Health Research Institute
Sun City
Arizona
85351
Recruiting
Sherye Sirrel
623-832-6522
sherye.sirrel@bannerhealth.com

Geolocation is 33.6471239, -117.8421325

University of California, Irvine
Irvine
California
92697
Not yet recruiting
n/a

Geolocation is 32.8283259, -117.255854

University of California, San Diego
La Jolla
California
92037-1707
Not yet recruiting
n/a

Geolocation is 34.0502898, -118.2117257

University of Southern California
Los Angeles
California
90033-5310
Recruiting
Nadine Diaz
323-442-7600
nadine.diaz@med.usc.edu

Geolocation is 34.070264, -118.4440562

University of California, Los Angeles
Los Angeles
California
90095
Not yet recruiting
n/a

Geolocation is 33.78659, -117.8750976

University of California, Irvine - Neuropsychiatric Center
Orange
California
92868-3298
Not yet recruiting
n/a

Geolocation is 37.3813444, -122.1802812

Stanford University
Palo Alto
California
94304
Not yet recruiting
n/a

Geolocation is 37.7748363, -122.3872576

University of California, San Francisco
San Francisco
California
94158
Not yet recruiting
n/a

Geolocation is 37.8961825, -121.9814354

University of California, Davis
Walnut Creek
California
94598-5900
Not yet recruiting
n/a

Geolocation is 41.3052226, -72.9268626

Yale University School of Medicine
New Haven
Connecticut
06510-3330
Not yet recruiting
n/a

Geolocation is 38.9156487, -77.0737149

Georgetown University
Washington
District of Columbia
20007-2145
Not yet recruiting
n/a

Geolocation is 38.9178427, -77.0218255

Howard University
Washington
District of Columbia
20060-0001
Not yet recruiting
n/a

Geolocation is 30.2606613, -81.460856

Mayo Clinic, Jacksonville
Jacksonville
Florida
32224
Not yet recruiting
n/a

Geolocation is 25.8176795, -80.1372757

Wien Center for Clinical Research
Miami Beach
Florida
33140-2877
Recruiting
Maria Greig-Custo
305-674-2121
maria.greig-custo@msmc.com

Geolocation is 28.0869646, -82.4698603

University of South Florida - Health Byrd Alzheimer Institute
Tampa
Florida
33613-4808
Recruiting
Jill Smith
813-974-1294
jsmith10@health.usf.edu

Geolocation is 33.7980995, -84.3259367

Emory University
Atlanta
Georgia
30322
Recruiting
Rebecca Byram
404-712-0195
rbyram@emory.edu

Geolocation is 41.8925085, -87.6161696

Northwestern University
Chicago
Illinois
60611-3010
Not yet recruiting
n/a

Geolocation is 41.8816606, -87.6926257

Rush University Medical Center
Chicago
Illinois
60612-3806
Not yet recruiting
n/a

Geolocation is 39.7794767, -86.1700894

Indiana University
Indianapolis
Indiana
46202
Recruiting
Scott Herring
317-963-7418
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
Not yet recruiting
n/a

Geolocation is 38.0369642, -84.5379455

University of Kentucky
Lexington
Kentucky
40504-2681
Not yet recruiting
n/a

Geolocation is 39.2713976, -76.5603828

Johns Hopkins University
Baltimore
Maryland
21224-2764
Not yet recruiting
n/a

Geolocation is 42.339904, -71.0898892

Brigham and Women's Hospital
Boston
Massachusetts
02115-5804
Not yet recruiting
n/a

Geolocation is 42.3377967, -71.0705763

Boston University
Boston
Massachusetts
02118-2307
Not yet recruiting
n/a

Geolocation is 42.3295957, -83.7092861

University of Michigan, Ann Arbor
Ann Arbor
Michigan
48105-2967
Not yet recruiting
n/a

Geolocation is 44.0557303, -92.5253639

Mayo Clinic, Rochester
Rochester
Minnesota
55905-0001
Not yet recruiting
n/a

Geolocation is 38.647459, -90.25731

Washington University, St. Louis
Saint Louis
Missouri
63108-2215
Not yet recruiting
n/a

Geolocation is 36.1922841, -115.1592718

Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas
Nevada
89106-0100
Not yet recruiting
n/a

Geolocation is 42.6547387, -73.7889689

Albany Medical College
Albany
New York
12208
Not yet recruiting
n/a

Geolocation is 42.9674726, -78.7986181

Dent Neurologic Institute
Buffalo
New York
14226-1727
Not yet recruiting
n/a

Geolocation is 40.74727, -73.9800645

New York University Medical Center
New York
New York
10016-6055
Not yet recruiting
n/a

Geolocation is 40.7916407, -73.9447994

Mount Sinai School of Medicine
New York
New York
10029-6552
Not yet recruiting
n/a

Geolocation is 40.8409822, -73.9447994

Columbia University
New York
New York
10032
Not yet recruiting
n/a

Geolocation is 41.0481178, -73.9301037

Nathan Kline Institute for Psychiatric Research
Orangeburg
New York
10962-1159
Not yet recruiting
n/a

Geolocation is 43.1301942, -77.6020569

University of Rochester
Rochester
New York
14620
Recruiting
Nancy Kowalski
585-760-6569
nancy_kowalski@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 Health Sciences
Winston-Salem
North Carolina
27157
Recruiting
Mieniecia Black
336-713-3133
mlblack@wakehealth.edu

Geolocation is 41.4766201, -81.5047772

Case Western Reserve University
Beachwood
Ohio
44122-4312
Not yet recruiting
n/a

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
97239-3011
Recruiting
Enrica DiMicco
503-494-0976
dimicco@ohsu.edu

Geolocation is 39.9583587, -75.1953934

University of Pennsylvania
Philadelphia
Pennsylvania
19104
Recruiting
Jessica Nunez
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
Kerstin Calia
401-444-9861
kcalia@lifespan.org

Geolocation is 41.8396817, -71.3883751

Butler Hospital Memory and Aging Program
Providence
Rhode Island
02906
Recruiting
Courtney Bodge
401-455-6403
cbodge@butler.org

Geolocation is 32.8113367, -96.8397899

University of Texas, Southwestern MC at Dallas
Dallas
Texas
75390
Not yet recruiting
Kasia Harrah
214-648-9118
kasia.harrah@utsouthwestern.edu

Geolocation is 29.7050857, -95.4018087

Baylor College of Medicine
Houston
Texas
77030
Recruiting
Ashley Lamb
713-798-4947
ashley.lamb@bcm.edu

Geolocation is 43.0772547, -89.430773

University of Wisconsin
Madison
Wisconsin
53792-0001
Not yet recruiting
n/a

Geolocation is 49.2601955, -123.2426367

University of British Columbia, Clinic for AD & Related Disorders
Vancouver
British Columbia
V6T 1Z3
Not yet recruiting
n/a

Geolocation is 42.9598744, -81.2353612

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

Geolocation is 42.9549508, -81.2301973

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

Geolocation is 43.7215696, -79.3768256

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

Geolocation is 45.4976084, -73.6292768

Jewish General Hospital Memory Clinic
Montreal
Quebec
H3T 1E2
Not yet recruiting
n/a
Lead Sponsor: 
Agency
University of Southern California
Collaborator Sponsor: 
Agency
Northern California Institute of Research and Education
National Institute on Aging (NIA)
Alzheimer's Therapeutic Research Institute
Facility Investigators: 
NameRoleAffiliation
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
Study Contact: 
NamePhone
ADNI Central Contact
888-223-6495
Locations
 
 
ClinicalTrials.gov ID 
NCT02854033 (follow link to view full record on ct.gov in new window)
Official Title: 
Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3) Protocol
Study Start Date: 
October 2016
Study End Date: 
October 2021
Disease Stage: 
Pre-clinical
Early
Middle
Enrollment: 
370-1200