Alzheimer's Disease Education and Referral Center

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 Age	Max Age	Gender	Healthy 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 study sites, please visit www.ADNI3.org.

Locations:

Map Marker		City	State	Zip Code	Status	Primary 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
	Barrow Neurological Institute	Phoenix	Arizona	85013	Recruiting	George Thomas 602-406-7165 george.thomas@dignityhealth.org
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	Recruiting	Helen Vanderswag 858-249-0556 hvanderswag@ucsd.edu
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	Recruiting	Hongzheng Zhang 925-357-6914 hzzhang@ucdavis.edu
Geolocation is 41.3052226, -72.9268626	Yale University School of Medicine	New Haven	Connecticut	06510-3330	Recruiting	Srinath Ramanan 203-764-6797 srinath.ramanan@yale.edu
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	Recruiting	Kim-Pokie Walker Moore 904-953-8014 walkermoore.kimpoki@mayo.edu
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	Recruiting	Kristine Lipowski 312-503-2486 k-lipowski@northwestern.edu
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	Recruiting	Dorothy Ross 859-323-2737 dross3@email.uky.edu
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	Recruiting	Jaimie Ziolkowski 734-647-7760 jziolkow@med.umich.edu
Geolocation is 44.0557303, -92.5253639	Mayo Clinic, Rochester	Rochester	Minnesota	55905-0001	Recruiting	Colleen Albers 507-293-4866 albers.colleen@mayo.edu
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	Recruiting	Mary Eglow 518-264-1131 eglowm@mail.amc.edu
Geolocation is 42.9674726, -78.7986181	Dent Neurologic Institute	Buffalo	New York	14226-1727	Recruiting	Caroline Kumm 716-558-3492 ckumm@dentinstitute.com
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	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	97239-3011	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
	Roper St. Francis	Charleston	South Carolina	29401	Recruiting	Arthur Williams 843-724-2208 arthur.williams@rsfh.com
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	Recruiting	Sandra Harding 608-262-4760 sjharding@medicine.wisc.edu
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

Agency
University of Southern California

Agency
Northern California Institute of Research and Education
National Institute on Aging (NIA)
Alzheimer's Therapeutic Research Institute

Facility Investigators:

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

Study Contact:

Name	Phone
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

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Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3)

Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3)