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 |
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 |
Loren Brown Ashley Contact this site |
Banner Alzheimer's Institute |
Phoenix | Arizona | 85006 | Recruiting |
David Parkhurst Contact this site |
Barrow Neurological Institute |
Phoenix | Arizona | 85013 | Recruiting |
Angelica Garcia Contact this site |
Banner Sun Health Research Institute |
Sun City | Arizona | 85351 | Recruiting |
Kelly Clark Contact this site |
University of California, Irvine |
Irvine | California | 92697 | Recruiting |
Beatriz Yañez Contact this site |
University of California, San Diego |
La Jolla | California | 92037 | Recruiting |
Mollie Paster Contact this site |
Long Beach VA Neuropsychiatric Research Program |
Long Beach | California | 90822 | Recruiting |
Sakineh (Parvin) Khalaghizadeh Contact this site |
University of Southern California |
Los Angeles | California | 90033 | Recruiting |
Nadine Diaz Contact this site |
University of California, Los Angeles |
Los Angeles | California | 90095 | Recruiting |
Celine Ossinalde Contact this site |
Stanford University |
Palo Alto | California | 94304 | Recruiting |
Joy Taylor Contact this site |
University of California, San Francisco |
San Francisco | California | 94158 | Recruiting |
Elise Ong Contact this site |
University of California, Davis |
Walnut Creek | California | 94598 | Recruiting |
Hongzheng Zhang Contact this site |
Yale University School of Medicine |
New Haven | Connecticut | 06510 | Recruiting |
Emmie Banks Contact this site |
Georgetown University |
Washington | District of Columbia | 20007 | Recruiting |
Kelly McCann Contact this site |
Howard University |
Washington | District of Columbia | 20060 | Recruiting |
Saba Wolday Contact this site |
Mayo Clinic, Jacksonville |
Jacksonville | Florida | 32224 | Recruiting |
Sochenda Chea Contact this site |
Wien Center for Clinical Research |
Miami Beach | Florida | 33140 | Recruiting |
Maria Greig-Custo Contact this site |
University of South Florida - Health Byrd Alzheimer Institute |
Tampa | Florida | 33613 | Recruiting |
Juris Janavs Contact this site |
Emory University |
Atlanta | Georgia | 30322 | Recruiting |
Rebecca Byram Contact this site |
Northwestern University |
Chicago | Illinois | 60611 | Recruiting |
Brittanie Muse Contact this site |
Rush University Medical Center |
Chicago | Illinois | 60612 | Recruiting |
Erin Yurko Contact this site |
Indiana University |
Indianapolis | Indiana | 46202 | Recruiting |
Christina Brown Contact this site |
University of Iowa |
Iowa City | Iowa | 52242 | Recruiting |
Karen Ekstam-Smith Contact this site |
University of Kansas |
Fairway | Kansas | 66205 | Recruiting |
Melissa Dodd Contact this site |
University of Kentucky |
Lexington | Kentucky | 40504 | Recruiting |
Dorothy Ross Contact this site |
Johns Hopkins University |
Baltimore | Maryland | 21224 | Recruiting |
Scott Rudow Contact this site |
Brigham and Women's Hospital |
Boston | Massachusetts | 02115-5804 | Recruiting |
Nancy Coppelman Contact this site |
Boston University |
Boston | Massachusetts | 02118 | Recruiting |
Jane Mwicigi Contact this site |
University of Michigan, Ann Arbor |
Ann Arbor | Michigan | 48105 | Recruiting |
Lisa Zbizek-Nulph Contact this site |
Mayo Clinic |
Rochester | Minnesota | 55905 | Recruiting |
Colleen Albers Contact this site |
Washington University, St. Louis |
Saint Louis | Missouri | 63108 | Recruiting |
David Winkfield Contact this site |
Cleveland Clinic Lou Ruvo Center for Brain Health |
Las Vegas | Nevada | 89106 | Recruiting |
Jennifer Hawse Contact this site |
Albany Medical College |
Albany | New York | 12208 | Recruiting |
Mary Eglow Contact this site |
Dent Neurologic Institute |
Buffalo | New York | 14226 | Recruiting |
Michelle Rainka Contact this site |
New York University Medical Center |
New York | New York | 10016 | Recruiting |
Karen Castro Contact this site |
Mount Sinai School of Medicine |
New York | New York | 10029 | Recruiting |
Jonathan Greenberg Contact this site |
Columbia University |
New York | New York | 10032 | Recruiting |
Anton Kociolek Contact this site |
Nathan Kline Institute for Psychiatric Research |
Orangeburg | New York | 10962 | Recruiting |
Antero Sarreal Contact this site |
University of Rochester |
Rochester | New York | 14620 | Recruiting |
Nancy Kowalski Contact this site |
Duke University Medical Center |
Durham | North Carolina | 27710 | Recruiting |
Cammie Hellegers Contact this site |
Wake Forest University Health Sciences |
Winston-Salem | North Carolina | 27157 | Recruiting |
Taylor Dannemiller Contact this site |
Case Western Reserve University |
Beachwood | Ohio | 44122 | Recruiting |
Parianne Fatica Contact this site |
Ohio State University |
Columbus | Ohio | 43210 | Recruiting |
Jennifer Icenhour Contact this site |
Oregon Health and Science University |
Portland | Oregon | 97239 | Recruiting |
Rachel Crissey Contact this site |
University of Pennsylvania |
Philadelphia | Pennsylvania | 19104 | Recruiting |
Grace Stockbower Contact this site |
University of Pittsburgh |
Pittsburgh | Pennsylvania | 15213 | Recruiting |
MaryAnn Oakley Contact this site |
Rhode Island Hospital |
Providence | Rhode Island | 02903 | Recruiting |
Terry Fogerty Contact this site |
Butler Hospital Memory and Aging Program |
Providence | Rhode Island | 02906 | Recruiting |
Tara Tang Contact this site |
Roper St. Francis |
Charleston | South Carolina | 29401 | Recruiting |
Allison Lapp Contact this site |
Vanderbilt University |
Nashville | Tennessee | 37235 | Recruiting |
Xuewen Gong Contact this site |
University of Texas, Southwestern MC at Dallas |
Dallas | Texas | 75390 | Recruiting |
Amy Browning Contact this site |
Baylor College of Medicine |
Houston | Texas | 77030 | Recruiting |
Nat Pacini Contact this site |
Houston Methodist |
Houston | Texas | 77030 | Recruiting |
Jennifer Garrett Contact this site |
University of Wisconsin |
Madison | Wisconsin | 53792 | Recruiting |
Sandra Harding Contact this site |
University of British Columbia, Clinic for AD & Related |
Vancouver | British Columbia | V6T 1Z3 | Recruiting |
Benita Mudge Contact this site |
Parkwood Institute |
London | Ontario | N6C 0A7 | Recruiting |
Charlene Bartha 519-685-4292 x42286 Charlene.Bartha@sjhc.london.on.ca |
St. Joseph's Health Center - Cognitive Neurology |
London | Ontario | N6C 4R3 | Not yet recruiting |
Charlene Bartha Contact this site |
Sunnybrook Health Sciences Centre |
Toronto | Ontario | M4N 3M5 | Recruiting |
Maryna Butenko Contact this site |
McGill University /Jewish General Hospital Memory Clinic |
Montreal | Quebec | H3T 1E2 | Recruiting |
Chris Hosein Contact this site |
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 | |
---|---|---|
ADNI Central Contact | 888-223-6495 | adni3-participate@usc.edu |
Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3) Protocol