Alzheimer's Disease Education and Referral Center

Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4)

Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4)

Overall Status: 
Recruiting
Brief Description: 

This study will test whether an investigational drug, solanezumab, can slow the progression of memory problems associated with amyloid, a protein that forms plaques in the brains of people with Alzheimer disease. Participants who have normal thinking and memory function but may be at risk for developing Alzheimer's dementia are invited to participate. All volunteers will undergo a positron emission tomography (PET) scan to be determine their brain amyloid levels.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
65 Years
85 Years
Both
Yes
Inclusion Criteria: 
    • Mini-Mental State Examination (MMSE) score of 25-30 inclusive
    • Global Clinical Dementia Rating (CDR) scale score of 0
    • Logical Memory II score of 6-18
    • PET scan that shows evidence of amyloid in the brain at screening
    • Study partner who has at least weekly contact with the participant (contact can be in person, via telephone, or by e-mail or other electronic means) and can provide information about him or her
Exclusion Criteria: 
    • Taking a prescription Alzheimer's medication (acetylcholinesterase inhibitor and/or memantine)
    • Lack of good venous access that precludes intravenous drug delivery or multiple blood draws
    • Current serious or unstable illness, including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease or other conditions that could interfere with the study
    • History within the last 5 years of a serious infectious disease affecting the brain (including neurosyphilis, meningitis, or encephalitis) or head trauma resulting in protracted loss of consciousness
    • History within the last 5 years of a primary or recurrent malignant disease, with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment
    • Known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions, including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis
    • At serious risk for suicide; history within the past 2 years of major depression or bipolar disorder
    • History within the past 5 years of chronic alcohol or drug abuse/dependence
    • Residence in a skilled nursing facility or nursing home
Detailed Description: 

The A4 study is a Phase III clinical trial for cognitively normal older adults whose brain scans show evidence of amyloid buildup, which places them at risk for memory loss and cognitive decline associated with Alzheimer's disease. The study will test the safety and efficacy of solanezumab, a monoclonal antibody, to see if it slows memory and cognitive decline and affects the buildup of amyloid plaques, as shown by brain imaging and other biomarkers. Participants will take either the study drug or a placebo as a monthly intravenous infusion for 3 years. Participants who do not qualify for A4 may be able to participate in a related substudy.

Central Contact Information: 

For more information about the A4 trial or study sites, please visit www.a4study.org. You may also call 1-844-A-4-STUDY (1-844-247-8839) or e-mail brainlink@ucsed.edu.

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
Candy Monarrez
602-839-6939
candy.monarrez@bannerhealth.com

Geolocation is 33.612697, -112.280129

Banner Sun Health Research Institute
Sun City
Arizona
85351
Recruiting
Molly Goddard
623-832-5726
molly.goddard@bannerhealth.com

Geolocation is 33.6471239, -117.8421325

University of California
Irvine
California
92697
Not yet recruiting
Deeba Sultani
949-824-5733
dsultani@uci.edu

Geolocation is 33.6471239, -117.8421325

University of California, Irvine-Institute for Memory Impairments & Neurological Disorders
Irvine
California
92697
Not yet recruiting
Beatriz Yanez
949-824-3250
byanez@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 34.0502898, -118.2117257

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

Geolocation is 34.070264, -118.4440562

University of California, Los Angeles
Los Angeles
California
90095
Recruiting
Celine Ossinalde
310-794-6191
cossinalde@metnet.ucla.edu

Geolocation is 37.9873593, -122.151897

University of California, Davis
Richmond
California
94804
Not yet recruiting
Katharine Vieira
916-803-3066
kevieira@ucdavis.edu

Geolocation is 33.78659, -117.8750976

University of California, Irvine-Brain Imaging Center
Orange
California
92868-3298
Recruiting
Andrea Weideman
714-456-5697
andrea.weideman@uci.edu

Geolocation is 37.3813444, -122.1802812

Stanford University School of Medicine
Palo Alto
California
94304
Recruiting
Emily Gere
650-852-3287
emilyg@stanford.edu

Geolocation is 37.7748363, -122.3872576

University of California, San Francisco
San Francisco
California
94158
Recruiting
Emmiline Chuu
415-476-0671
echuu@memory.uscf.edu

Geolocation is 41.3052226, -72.9268626

Yale University School of Medicine
New Haven
Connecticut
06510
Recruiting
Barbaralynn Moseman
203-764-8100
barbaralynn.moseman@yale.edu

Geolocation is 38.9178427, -77.0218255

Howard University
Washington
District of Columbia
20060
Recruiting
Oludolapo O. Ogunlana
202-865-3776
oogunlana@howard.edu

Geolocation is 38.9079086, -77.0716829

Georgetown University
Washington
District of Columbia
20057
Recruiting
Erica Christian
202-687-8800
ec912@georgetown.edu

Geolocation is 30.2606613, -81.460856

Mayo Clinic
Jacksonville
Florida
32224
Recruiting
Dana Haley
904-953-9680
haley.dana@mayo.edu

Geolocation is 25.7138002, -80.1596041

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

Geolocation is 28.0869646, -82.4698603

University of South Florida-Byrd Alzheimer Institute
Tampa Bay
Florida
33613
Recruiting
Kelly Rodrigo
813-974-4904
krodrig5@health.usf.edu

Geolocation is 26.7619563, -80.1037721

Premiere Research Institute
West Palm Beach
Florida
33407
Recruiting
Teresa Villena
561-845-0500 Ext. 124
tvillena@aol.com

Geolocation is 33.828105, -84.3279093

Emory University
Atlanta
Georgia
30329
Recruiting
Gail Schwartz
404-728-6395
gschwar@emory.edu

Geolocation is 41.9214378, -87.6513043

Rush University Medical Center
Chicago
Illinois
60614
Not yet recruiting
Lindsay M. Pluff
312-563-4111
Lindsay_M_Pluff@rush.edu

Geolocation is 41.8925085, -87.6161696

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

Geolocation is 39.7794767, -86.1700894

Indiana University
Indianapolis
Indiana
46202
Recruiting
Nancy McClaskey
317-963-7429
nmcclask@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
Aiden Bondurant
913-945-7671
abondurant@kumc.edu

Geolocation is 38.0369642, -84.5379455

University of Kentucky
Lexington
Kentucky
40504
Recruiting
Kendra Bates
859-323-5550
kendra.bates@uky.edu

Geolocation is 39.2713976, -76.5603828

Johns Hopkins University
Baltimore
Maryland
21224
Recruiting
Julia J. Pedroso
410-550-9054
jpedroso@jhmi.edu

Geolocation is 42.3377967, -71.0705763

Boston University
Boston
Massachusetts
02118
Recruiting
Jane Mwicigi
617-638-5670
jmwicigi@bu.edu

Geolocation is 42.339904, -71.0898892

Brigham and Women's Hospital
Boston
Massachusetts
02115
Recruiting
Allison Pietras
617-278-0379
apietras@partners.org

Geolocation is 42.3295957, -83.7092861

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

Geolocation is 44.0557303, -92.5253639

Mayo Clinic
Rochester
Minnesota
55905
Recruiting
Mayo Clinic
507-284-1324
a4study@mayo.edu

Geolocation is 38.647459, -90.25731

Washington University
St. Louis
Missouri
63108
Recruiting
Pamela Millsap
314-286-2363
millsapp@abraxas.wustl.edu

Geolocation is 41.2552541, -95.9796225

University of Nebraska Medical Center
Omaha
Nebraska
68198
Recruiting
Barbara Bayer
402-552-6005
blbayer@unmc.edu

Geolocation is 36.1922841, -115.1592718

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

Geolocation is 42.9674726, -78.7986181

Dent Neurologic Institute
Amherst
New York
14226
Recruiting
Caroline Kumm
716-558-3492
ckumm@dentinstitute.com

Geolocation is 40.8409822, -73.9447994

Columbia University
New York
New York
10032
Not yet recruiting
Ruth Tejeda
212-305-7661
rbt41@columbia.edu

Geolocation is 40.7916407, -73.9447994

Mount Sinai School of Medicine
New York
New York
10029
Recruiting
Michael T. Kinsella
212-659-8883
michael.kinsella@mssm.edu

Geolocation is 40.74727, -73.9800645

New York University Medical Center
New York
New York
10016
Not yet recruiting
Christina Michel
212-263-0771
Christina.michel@nyumc.org

Geolocation is 40.8138912, -73.9624327

Weill Cornell Memory Disorders Program
New York
New York
10027
Not yet recruiting
Erin Hibbard
212-746-6580
erh2009@med.cornell.edu

Geolocation is 41.0481178, -73.9301037

Nathan Kline Institute for Psychiatric Research
Orangeburg
New York
10962
Not yet 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
Susan Salem-Spencer
585-760-6562
susan_salem-spencer@urmc.rochester.edu

Geolocation is 36.0906568, -80.2715385

Wake Forest University Health Sciences
Winston-Salem
North Carolina
27157
Recruiting
Erin Caulder
336-713-8847
ecaulder@wakehealth.edu

Geolocation is 41.4766201, -81.5047772

Case Western Reserve University
Beachwood
Ohio
44122
Recruiting
Maria Gross
216-464-6454
Maria.Gross@uhhospitals.org

Geolocation is 36.1510884, -95.9945809

Tulsa Clinical Research
Tulsa
Oklahoma
74101
Recruiting

Geolocation is 45.4618086, -122.7181902

Oregon Health & Science University
Portland
Oregon
97219
Recruiting
Elisabeth Loree
503-494-7615
loree@ohsu.edu

Geolocation is 39.9556241, -75.1647529

Drexel University College of Medicine
Philadelphia
Pennsylvania
19102
Not yet recruiting
Kate Bowen
215-762-1776
kbowen@drexelmed.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
Not yet recruiting
Katy Zorich
412-692-2730
orchowskik3@upmc.edu

Geolocation is 41.8396817, -71.3883751

Butler Hospital Memory and Aging Program
Providence
Rhode Island
02906
Recruiting
Diane Monast
401-455-6403
dmonast@butler.org

Geolocation is 41.816736, -71.4091563

Rhode Island Hospital
Providence
Rhode Island
02903
Recruiting
Michele Astphan
401-444-2484
mastphan@lifespan.org

Geolocation is 32.9221152, -80.0367259

Roper St. Francis Hospital
North Charleston
South Carolina
29406
Recruiting
Catherine Danner
843-724-2302
cbri@rsfh.com

Geolocation is 32.8113367, -96.8397899

University of Texas Southwestern Medical Center
Dallas
Texas
75390-9129
Recruiting
Kathleen Koch
214-648-9343
kathleen.koch@utsouthwestern.edu

Geolocation is 29.7050857, -95.4018087

Baylor College of Medicine
Houston
Texas
77030
Recruiting
Kimberley D. Brown
713-798-5385
kdbrown@bcm.edu

Geolocation is 47.5405059, -122.3045438

University of Washington
Seattle
Washington
98108
Not yet recruiting
Anita Ranta
206-764-2339
rantaa@uw.edu

Geolocation is 43.0716332, -89.4600369

University of Wisconsin
Madison
Wisconsin
53705
Recruiting
Zachary Zugin
608-256-1901 x1640
zcz@medicine.wisc.edu

Geolocation is 49.2650543, -123.2459921

University of British Columbia
Vancouver
British Columbia
V6T 2B5
Not yet recruiting
Benita Mudge
604-822-7990
benita.mudge@vch.ca

Geolocation is 42.9555117, -81.2257216

Parkwood Hospital
London
Ontario
N6C 5J1
Not yet recruiting
Patricia Sargeant
519-685-4292 x42896
Patricia.sargeant@sjhc.london.on.ca

Geolocation is 43.7215696, -79.3768256

Sunnybrook Health Sciences Centre
Toronto
Ontario
M4N 3M5
Not yet recruiting
Joanne Lawrence
416-480-6108
joanne.lawrence@sunnybrook.ca

Geolocation is 43.7585342, -79.3535081

Toronto Memory Program
Toronto
Ontario
M3B 2S7
Recruiting
Atif Shaikh
416-386-9761
ashaikh@memorydisorders.ca
Lead Sponsor: 
Agency
Eli Lilly and Company
Collaborator Sponsor: 
Agency
Alzheimer's Disease Cooperative Study (ADCS)
Facility Investigators: 
NameRole
Eli Lilly
Study Director
Study Contact: 
NamePhoneEmail
ADCS
1-844-247-8839
Locations
 
 
ClinicalTrials.gov ID 
Official Title: 
Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4 Study)
Study Start Date: 
February 2014
Study End Date: 
December 2018
Disease Stage: 
Pre-clinical
Enrollment: 
1150