Alzheimer's Disease Neuroimaging Initiative 2



Status:Active, not recruiting
Conditions:Alzheimer Disease, Cognitive Studies
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:55 - 90
Updated:3/6/2019
Start Date:January 2011
End Date:May 2019

Use our guide to learn which trials are right for you!

The purpose of this study is to build upon the information obtained in the original
Alzheimer's Disease Neuroimaging Initiative (ADNI1) and ADNI-GO (Grand Opportunity; a study
funded through an NIH grant under the American Recovery and Reinvestment Act), to examine how
brain imaging technology can be used with other tests to measure the progression of mild
cognitive impairment (MCI) and early Alzheimer's disease (AD). ADNI2 seeks to inform the
neuroscience of AD. This information will aid in the early detection of AD, and in measuring
the effectiveness of treatments in future clinical trials.

The Alzheimer's Disease Neuroimaging Initiative (ADNI) began in October 2004 as a landmark
study with a public-private partnership that gathered and analyzed thousands of brain scans,
genetic profiles and biomarkers in blood and cerebrospinal fluid (CSF). Although the original
goal was to define biomarkers for use in clinical trials to determine the best way to measure
treatment effects of Alzheimer's disease (AD), the goal has been expanded to using biomarkers
to identify AD at a pre-dementia stage. ADNI1 involves scientists at 59 research centers, 54
in the U.S. and five in Canada. Originally 800 participants were enrolled. This group was
comprised of 200 participants with AD, 400 with mild cognitive impairment (MCI) and 200 with
normal cognition. In ADNI-GO, an estimated 200 participants with early amnestic MCI (EMCI)
were enrolled to understand and characterize the mildest symptomatic phase of AD. An
additional 650 participants will be enrolled under ADNI2.

Some of the leading-edge technologies under study are brain-imaging techniques, such as
positron emission tomography (PET), including FDG-PET (which measures glucose metabolism in
the brain); PET using a radioactive compound (Florbetapir F 18) that measures brain
beta-amyloid; and structural MRI. Brain scans are showing scientists how the brain's
structure and function change as AD starts and progresses. Biomarkers in cerebrospinal fluid
are revealing other changes that could identify which patients with MCI will develop
Alzheimer's. Scientists are looking at levels of beta-amyloid and tau in cerebrospinal fluid.
(Abnormal amounts of the amyloid and tau proteins in the brain are hallmarks of Alzheimer's
disease.)

ADNI2 extends the work of ADNI1 and ADNI GO to understand the progression of AD. The overall
goal is to determine the relationships among the clinical, cognitive, imaging, genetic and
biochemical biomarker characteristics of the entire spectrum of AD, 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 AD, development of better clinical and imaging/fluid
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 AD.

Inclusion Criteria:

Participants will be classified as either normal controls, SMC, EMCI, LMCI or AD
participants. General Inclusion Criteria will apply to all groups, with specific criteria
for each group as described below:

General (applies to each category):

- Geriatric Depression Scale less than 6.

- Age between *55-90 (inclusive). *For normal controls and SMC participants, age must be
between 65-90.

- 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.

- Visual and auditory acuity adequate for neuropsychological testing.

- Good general health with no diseases expected to interfere with the study.

- Participant is not pregnant, lactating, or of childbearing potential (i.e. women must
be two years post-menopausal or surgically sterile).

- Willing and able to participate in a longitudinal imaging study.

- Hachinski less than or equal to 4.

- Completed six grades of education or has a good work history (sufficient to exclude
mental retardation).

- Must speak English or Spanish fluently.

- Willing to undergo repeated MRIs (3Tesla) and at least two PET scans (one FDG and one
Amyloid imaging) and no medical contraindications to MRI.

- Agrees to collection of blood for Genome Wide Association Studies (GWAS), APOE testing
and DNA and RNA banking.

- Agrees to collection of blood for biomarker testing.

- Agrees to at least one lumbar puncture for the collection of CSF.

Specific Inclusion Criteria for normal controls:

- Participant must be free of memory complaints, verified by a study partner.

- Normal memory function score on Wechsler Memory Scale (adjusted for education)

- Mini-Mental State Exam (MMSE) score between 24 and 30 (inclusive)

- Clinical Dementia Rating (CDR) = 0; Memory Box score must be 0

- Cognitively normal, based on an absence of significant impairment in cognitive
functions or activities of daily living

- Stability of Permitted Medications for 4 weeks. In particular, participants may take:

- Antidepressants lacking significant anticholinergic side effects

- Estrogen replacement therapy is permissible

- Gingko biloba is permissible, but discouraged

- Washout from psychoactive medication (e.g., excluded antidepressants,
neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4
weeks prior to screening

Specific Inclusion Criteria for SMC participants:

- Subjects that are "self-referrals" that have a significant subjective memory concern

- Significant memory concern confirmed by a Cognitive Change Index score of more than or
equal to 16

- Normal memory function score on Wechsler Memory Scale (adjusted for education)

- Mini-Mental State Exam (MMSE) score between 24 and 30 (inclusive)

- Clinical Dementia Rating (CDR) = 0; Memory Box score must be 0

- Cognitively normal, based on the absence of significant memory impairment in cognitive
function or activities of daily living

- Stability of Permitted Medications for 4 weeks. In particular, subjects may take:

- Antidepressants lacking significant anticholinergic side effects

- Estrogen replacement therapy is permissible

- Gingko biloba is permissible, but discouraged

- Washout from psychoactive medication (e.g., excluded antidepressants,
neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4
weeks prior to screening

Specific Inclusion Criteria for EMCI and LMCI participants:

- Participant must have a subjective memory concern as reported by participant, study
partner, or clinician

- Abnormal memory function score on Wechsler Memory Scale (adjusted for education)

- Mini-Mental State Exam (MMSE) score between 24 and 30 (inclusive)

- Clinical Dementia Rating (CDR) = 0.5; Memory Box score must be at least 0.5

- General cognition and functional performance sufficiently preserved such that a
diagnosis of AD cannot be made by the site physician at the time of the screening
visit

- Stability of Permitted Medications for 4 weeks. In particular, participants may take:

- Antidepressants lacking significant anticholinergic side effects

- Estrogen replacement therapy

- Gingko biloba is permissible, but discouraged

- Washout from psychoactive medication (e.g., excluded antidepressants,
neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4
weeks prior to screening

- Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks
prior to screening

Specific Inclusion Criteria for AD participants:

- Participant must have a subjective memory concern as reported by participant, study
partner, or clinician

- Abnormal memory function score on Wechsler Memory Scale (adjusted for education)

- Mini-Mental State Exam (MMSE) score between 20 and 26 (inclusive)

- Clinical Dementia Rating (CDR) = 0.5 or 1.0

- National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's
Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD

- Stability of Permitted Medications for 4 weeks. In particular, participants may take:

- Antidepressants lacking significant anticholinergic side effects

- Estrogen replacement therapy

- Gingko biloba is permissible, but discouraged

- Washout from psychoactive medication (e.g., excluded antidepressants,
neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4
weeks prior to screening

- Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks
prior to screening

Specific Inclusion Criteria for 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 (CN), Mild Cognitive Impairment
(MCI), or Early Mild Cognitive Impairment (EMCI) regardless of whether a diagnostic
conversion has occurred since initial enrollment in ADNI.

- Willing and able to continue to participate in an ongoing longitudinal study. A
reduced battery of tests is allowable if the participant 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:

General (applies to each category):

- Screening/baseline MRI scan with evidence of infection, infarction, or other focal
lesions; Participants 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, bipolar disorder as described in Diagnostic and Statistical Manual
of Mental Disorders, Fourth Edition (DSM-IV) within the past 1 year

- Currently treated with medication for obsessive-compulsive disorder or attention
deficit disorder

- History of schizophrenia

- History of alcohol or substance abuse or dependence within the past 2 years

- Any significant systemic illness or unstable medical condition which could lead to
difficulty complying with the protocol

- Clinically significant abnormalities in B12, or TFTs that might interfere with the
study

- Residence in skilled nursing facility

- Current use of specific psychoactive medications (e.g.,certain antidepressants,
neuroleptics, chronic anxiolytics or sedative hypnotics, etc.); Current use of
warfarin or dabigatran (exclusionary for lumbar puncture).

- Use of investigational agents one month prior to entry and for the duration of the
trial

- Participation in clinical studies involving neuropsychological measures being
collected more than one time per year

- Exclusion for FDG PET scan and amyloid imaging with Florbetapir F 18: Current or
recent participation in any procedures involving radioactive agents such that the
total radiation dose exposure to the participant in any given year would exceed the
limits of annual and total dose commitment set forth in the US Code of Federal
Regulations (CFR) Title 21 Section 361.1.

- Exceptions to these guidelines may be considered on a case-by-case basis at the
discretion of the protocol director

Specific Exclusion Criteria for normal controls and SMC participants:

- Any significant neurologic 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 neurologic
defaults or known structural brain abnormalities

Specific Exclusion Criteria for EMCI and LMCI participants:

- Any significant neurologic disease other than suspected incipient 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 neurologic defaults or known structural brain abnormalities.

Specific Exclusion Criteria for AD participants:

- Any significant neurologic 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
neurologic defaults or known structural brain abnormalities.

Specific Exclusion Criteria for follow-up participants from ADNI1 and ADNI GO:

- Participants will not be able to participate in FDG PET scan and amyloid imaging with
Florbetapir F 18 if the following is true: Current or recent participation in any
procedures involving radioactive agents such that the total radiation dose exposure to
the participant in any given year would exceed the limits of annual and total dose
commitment set forth in the US Code of Federal Regulations (CFR) Title 21 Section
361.1.
We found this trial at
54
sites
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, CA
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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Amherst, New York 14226
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Ann Arbor, Michigan 48105
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Beachwood, Ohio 44122
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One Silber Way
Boston, Massachusetts 02215
(617) 353-2000
Boston University Boston University is no small operation . With over 33,000 undergraduate and graduate...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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303 East Superior Street
Chicago, Illinois 60611
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Irvine, California 92697
949-824-5011
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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Jacksonville, Florida 32216
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Kansas City, Kansas
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Lebanon, New Hampshire 03756
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Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Martinez, California 94553
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Miami Beach, Florida 33140
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New York, New York 10021
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New York, New York 10029
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North Charleston, South Carolina 29406
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Orange, CA
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Palo Alto, California 94304
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Phoenix, Arizona 85006
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Providence, Rhode Island 02906
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Saint Louis, Missouri 63110
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San Francisco, California 94143
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Sun City, Arizona 85351
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Tampa, FL
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Washington, District of Columbia 20060
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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West Palm Beach, Florida 33407
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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