Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss



Status:Active, not recruiting
Conditions:Cognitive Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:65 - 85
Updated:12/6/2018
Start Date:February 28, 2014
End Date:July 22, 2022

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

The purpose of this study is to test whether an investigational drug called solanezumab can
slow the progression of memory problems associated with brain amyloid (protein that forms
plaques in the brains of people with Alzheimer Disease [AD]).

The A4 study is a clinical trial for older individuals who have evidence of amyloid plaque
build-up in their brains who may be at risk for memory loss and cognitive decline due to
Alzheimer's disease. The A4 study will test an anti-amyloid investigational drug in older
individuals who do not yet show symptoms of Alzheimer's disease cognitive impairment or
dementia with the aim of slowing memory and cognitive decline. The A4 study will also test
whether anti-amyloid treatment can delay the progression of AD related brain injury on
imaging and other biomarkers.

Inclusion Criteria:

- Has a Mini-Mental State Examination (MMSE) score at screening of 25 to 30

- Has a global Clinical Dementia Rating (CDR) scale score at screening of 0

- Has a Logical Memory II score at screening of 6 to 18

- Has a florbetapir positron emission tomography (PET) scan that shows evidence of brain
amyloid pathology at screening

- Has a study partner that is willing to participate as a source of information and has
at least weekly contact with the participant (contact can be in-person, via telephone
or electronic communication)

Exclusion Criteria:

- Is receiving a prescription acetylcholinesterase inhibitor (AChEI) and/or memantine at
screening or baseline

- Lacks good venous access, such that intravenous drug delivery or multiple blood draws
would be precluded

- Has current serious or unstable illness including cardiovascular, hepatic, renal,
gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic,
or hematologic disease or other conditions that, in the investigator's opinion, could
interfere with the analyses of safety and efficacy in this study

- Has had a 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

- Has had a history within the last 5 years of a primary or recurrent malignant disease
with the exception of any in situ cancer that was appropriately treated and is being
appropriately monitored, such as resected cutaneous squamous cell carcinoma in situ or
in situ prostate cancer with normal prostate-specific antigen post-treatment

- Has a 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)

- Is clinically judged by the investigator to be at serious risk for suicide

- Has a history within the past 2 years of major depression or bipolar disorder as
defined by the most current version of the Diagnostic and Statistical Manual of Mental
Disorders (DSM)

- Has a history within the past 5 years of chronic alcohol or drug abuse/dependence as
defined by the most current version of the DSM

Open-Label Inclusion Criteria:

- All participants who complete the placebo-controlled period will be allowed to
continue into the open-label period
We found this trial at
63
sites
Orlando, Florida 32806
Principal Investigator: Esteban Olivera
Phone: 407-462-9299
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: James Lah
Phone: 404-728-6395
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Marissa Natelson Love
Phone: 205-996-3679
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
Principal Investigator: Gad Marshall
Phone: 617-278-0379
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Principal Investigator: Mary Quiceno
Phone: 214-648-9343
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Joseph Kass
Phone: 713-798-4734
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
Principal Investigator: Delwyn Miller
Phone: 319-353-5158
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
Principal Investigator: Sarah Kremen
Phone: 310-794-6039
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Lisa Silbert
Phone: 503-494-7615
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
Principal Investigator: Brian Ott
Phone: 401-444-2484
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Anton Porsteinsson
Phone: 585-760-6562
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Amanda Smith
Phone: 813-974-4355
University of South Florida The University of South Florida is a high-impact, global research university...
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Amherst, New York 14226
Principal Investigator: Horacio Capote
Phone: 716-819-4117
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Judith Heidebrink
Phone: 734-647-7760
University of Michigan The University of Michigan was founded in 1817 as one of the...
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733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Principal Investigator: Paul Rosenburg
Phone: 410-550-9883
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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6400 Perkins Rd
Baton Rouge, Louisiana 70808
(225) 763-2500
Principal Investigator: Jeffrey Keller
Phone: 225-763-3190
Pennington Biomedical Research Center Unlike other medical research facilities where science occurs in separate labs...
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Beachwood, Ohio 44122
Principal Investigator: Alan Lerner
Phone: 216-464-6454
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1 Boston Medical Center Place
Boston, Massachusetts 02118
617.638.8000
Principal Investigator: Robert Stern
Phone: 617-638-5670
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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Charleston, South Carolina 29401
Principal Investigator: Jacobo Mintzer
Phone: 843-724-2302
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Sandra Weintraub
Phone: 312-503-2486
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Chicago, Illinois 60612
Principal Investigator: Neelum Aggarwal
Phone: 312-563-4111
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Chicago, Illinois 60640
Principal Investigator: John Lavaccare
Phone: 773-275-3500
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Delray Beach, Florida 33445
Principal Investigator: Mark Brody
Phone: 561-374-8463
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Fairway, Kansas 66205
Principal Investigator: Jeffrey Burns
Phone: 913-945-5033
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Houston, Texas 77030
Principal Investigator: Joseph Masdeu
Phone: 713-441-1150
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Principal Investigator: Martin Farlow
Phone: 317-963-7429
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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Irvine, California 92697
Principal Investigator: Aimee Pierce
Phone: 949-824-2382
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Jacksonville, Florida 32216
Principal Investigator: Neil Graff-Radford
Phone: 904-953-9680
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Doug Galasko
Phone: 858-246-1245
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Las Vegas, Nevada 89102
Principal Investigator: Charles Bernick
Phone: 702-483-6026
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Lexington, Kentucky
859) 257-9000
Principal Investigator: Gregory Jicha
Phone: 859-323-1331
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Los Angeles, California 90033
Principal Investigator: Lon Schneider
Phone: 323-442-7594
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Madison, Wisconsin 53705
Principal Investigator: Cynthia Carlsson
Phone: 608-256-1901
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Miami Beach, Florida 33140
Principal Investigator: Ranjan Duara
Phone: 305-674-2121
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Chris Van Dyck
Phone: 203-764-8100
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New York, New York 10021
Principal Investigator: Melanie Shulman
Phone: 212-263-0771
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New York, New York 10021
Principal Investigator: Michael Lin
Phone: 212-746-6580
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Karen Bell
Phone: 212-305-7661
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, New York 10029
Principal Investigator: M Sano
Phone: 212-659-8883
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Daniel Murman
Phone: 402-552-6150
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Orange, California 92868
Principal Investigator: Steve Potkin
Phone: 714-456-5697
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Palo Alto, California 94304
Principal Investigator: Jerome Yesavage
Phone: 650-852-3287
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Philadelphia, Pennsylvania 19102
Principal Investigator: G. Peter Gliebus
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Philadelphia, Pennsylvania 19104
Principal Investigator: Jason Karlawish
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Phoenix, Arizona 85006
Principal Investigator: Anna Burke
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Phoenix, Arizona 85013
Principal Investigator: Marwan Sabbagh
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Oscar Lopez
Phone: 412-692-2730
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345 Blackstone Blvd
Providence, Rhode Island 02906
(401) 455-6200
Principal Investigator: Stephen Salloway
Phone: 401-455-6403
Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
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Rochester, Minnesota 55905
Principal Investigator: David Knopman
Phone: 507-284-1324
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Sacramento, California 95816
Principal Investigator: Shawn Kile
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Francisco, California 94143
Principal Investigator: Adam Boxer
Phone: 415-476-0671
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Santa Ana, California 92705
Principal Investigator: John Duffy
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Seattle, Washington 98195
Principal Investigator: Elaine Peskind
Phone: 206-764-2339
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Sun City, Arizona 85351
Principal Investigator: Edward Zamrini
Phone: 623-832-6530
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The Villages, Florida 32162
Principal Investigator: David Subich
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Tulsa, Oklahoma 74104
Principal Investigator: Ralph Richter
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Walnut Creek, California 94598
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
Principal Investigator: Raymond Turner
Phone: 202-687-8800
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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Washington, District of Columbia 20060
Principal Investigator: Thomas Obisesan
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West Palm Beach, Florida 33407
Principal Investigator: Carl Sadowsky
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Winston-Salem, North Carolina 26157
Principal Investigator: Suzanne Craft
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