A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease



Status:Terminated
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:55 - 85
Updated:7/26/2018
Start Date:June 2016
End Date:May 2017

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A 24-Month, Phase 3, Multicenter, Placebo-Controlled Study of Efficacy and Safety of Solanezumab Versus Placebo in Prodromal Alzheimer's Disease

The main purpose of this study is to investigate the safety and efficacy of the study drug
solanezumab in participants with prodromal Alzheimer's disease (AD).


Inclusion Criteria:

- Has a diagnosis by the study investigator of a clinical syndrome of cognitive
impairment consistent with prodromal AD per International Working Group (IWG)
diagnostic criteria or mild cognitive impairment (MCI) due to AD per National
Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria.

- Scores 17-28 on Montreal Cognitive Assessment (MoCA) at screening.

- Scores <27 on free recall cutoff score from the Free and Cued Selective Reminding Test
(FCSRT) (Picture version) at screening.

- Scores ≤4 on Modified Hachinski Ischemia Scale (MHIS).

- Scores >0 on the Functional Activities Questionnaire (FAQ).

- Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (CSF)
result at screening consistent with the presence of amyloid pathology.

Exclusion Criteria:

- Has had MRI or computerized tomography (CT) of brain within previous 2 years showing
pathology that would be inconsistent with a diagnosis of AD.

- Has known allergy to humanized monoclonal antibodies.

- Has an ongoing clinically significant laboratory abnormality, as determined by the
investigator.

- Has screening MRI with results showing >4 amyloid related imaging abnormalities H
(ARIA-H) micro-hemorrhages or presence of ARIA-E.

- Has any contraindications for MRI studies, including claustrophobia, the presence of
metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with
MRI.

- Has received treatment with a stable dose of an acetylcholinesterase (AChEI) inhibitor
or memantine for less than 2 months before randomization. (If a participant has
recently stopped AChEIs and/or memantine, he or she must have discontinued treatment
at least 2 months before randomization.)
We found this trial at
97
sites
Kansas City, Missouri 64111
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
Principal Investigator: Rhonna Shatz
Phone: 513-558-1141
University of Cincinnati Medical Center Opening in 1823 as the country
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6161 Kempsville Circle
Norfolk, Virginia 23502
(757) 261-4986
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Principal Investigator: Craig Curtis
Phone: 407-426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
Principal Investigator: Jason Miller
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
Principal Investigator: Donald Royall
Phone: 210-567-1255
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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2450 E. River Road
Tucson, Arizona 85718
520-320-2147
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
Principal Investigator: Dwight St Clair
Phone: 316-689-6635
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Abington, Pennsylvania 19001
Principal Investigator: David Weisman
Phone: 215-957-9250
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Principal Investigator: David Hart
Phone: 518-459-8106
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
Principal Investigator: Lorraine Spikol
Phone: 610-402-9543
Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
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Allentown, Pennsylvania 18104
Principal Investigator: Paul Gross
Phone: 610-820-0342
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Principal Investigator: Robert Riesenberg
Phone: 404-881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Baltimore, Maryland 21208
Principal Investigator: Alan Jonas
Phone: 410-602-1440
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Baltimore, Maryland 21285
Principal Investigator: Scott Aaronson
Phone: 410-938-3125
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733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Principal Investigator: Paul Rosenberg
Phone: 410-550-9883
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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Bennington, Vermont 05201
Principal Investigator: Cynthia Murphy
Phone: 413-281-0576
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Bolivar, Missouri 65613
Principal Investigator: Curtis Schreiber
Phone: 417-327-3530
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Champaign, Illinois 61820
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Charlotte, North Carolina 28211
Principal Investigator: Mohammed Bolouri
Phone: 704-364-4000
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Chesterfield, Missouri 63141
Principal Investigator: Siddharth Kaul
Phone: 636-220-1200
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Colorado Springs, Colorado 80910
Principal Investigator: Joel Dickerman
Phone: 719-634-6576
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Creve Coeur, Missouri 63141
Principal Investigator: Franco Sicuro
Phone: 314-298-0001
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Dallas, Texas 75231
Principal Investigator: Michael Downing
Phone: 214-369-2600
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Dallas, Texas 75219
Principal Investigator: Claudia Padilla
Phone: 214-820-7665
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Dayton, Ohio 45414
Principal Investigator: Joel Vandersluis
Phone: 937-224-8200
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Delray Beach, Florida 33445
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Denver, Colorado 80218
Principal Investigator: JACK KLAPPER
Phone: 303-839-9900
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East Providence, Rhode Island 02914
Principal Investigator: John Stoukides
Phone: 401-435-8950
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Eatontown, New Jersey 07724
Principal Investigator: Mark Ornstein
Phone: 732-263-0101
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Elk Grove Village, Illinois 60007
Principal Investigator: Concetta Forchetti
Phone: 847-953-8553
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Farmington Hills, Michigan 48334
Principal Investigator: Martin Belkin
Phone: 248-957-8940
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Fort Myers, Florida 33912
Principal Investigator: Frederick Schaerf
Phone: 239-939-7777
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Fort Wayne, Indiana 46805
Principal Investigator: James Stevens
Phone: 260-436-2416
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Gainesville, Georgia 30501
Principal Investigator: Christopher Recknor
Phone: 678-928-6482
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Glendale, California 91206
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Hattiesburg, Mississippi 39401
Principal Investigator: Ronald Schwartz
Phone: 601-268-5620
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Hollywood, Florida 33021
Principal Investigator: Harvey Schwartz
Phone: 954-366-0277
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Houston, Texas 77030
Principal Investigator: Joseph Masdeu
Phone: 713-441-1150
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Houston, Texas 77054
Principal Investigator: Paul Schulz
Phone: 713-486-0500
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7666 Charlotte Highway
Indian Land, South Carolina 29707
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Principal Investigator: Martin Farlow
Phone: 317-963-7402
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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Indianapolis, Indiana 46256
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Jacksonville, Florida 32216
Principal Investigator: Nandita Joshi
Phone: 904-281-5757
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Jenkintown, Pennsylvania 19046
Principal Investigator: Marvin Kalafer
Phone: 215-884-1700
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Kirkland, Washington 98034
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Lake Charles, Louisiana 70601
Principal Investigator: Kashinath Yadalam
Phone: 337-564-6405
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Las Vegas, Nevada 89113
Principal Investigator: Bharat Mocherla
Phone: 702-666-6066
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166 Pasadena Drive
Lexington, Kentucky 40503
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Methuen, Massachusetts 01844
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Miami, Florida 33137
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Miami Beach, Florida 33140
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Monroe, New Jersey 08831
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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 Port Richey, Florida 34652
Principal Investigator: Vikram Atit
Phone: 727-849-4131
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Newark, Delaware 19713
Principal Investigator: James Ellison
Phone: 302-320-2620
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Ocoee, Florida 34761
Principal Investigator: Kelly Taylor
Phone: 407-654-2724
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Oxnard, California
Principal Investigator: James Sutton
Phone: 805-278-4148
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Pensacola, Florida 32504
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350 W Thomas Rd
Phoenix, Arizona 85013
(602) 406-3000
Principal Investigator: Marwan Sabbagh
Phone: 602-406-4784
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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Phoenix, Arizona 85004
Principal Investigator: Stephen Flitman
Phone: 602-265-6500
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Phoenix, Arizona 85006
Principal Investigator: William Burke
Phone: 602-829-9608
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Plains, Pennsylvania 18705
Principal Investigator: Mario Cornacchione
Phone: 570-829-1095
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Plymouth, Massachusetts 02360
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Pompano Beach, Florida 33064
Principal Investigator: Jose De La Gandara
Phone: 954-786-7331
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Portland, Oregon 97210
Principal Investigator: Scott Losk
Phone: 503-293-5039
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Portland, Oregon 97225
Principal Investigator: Michael Mega
Phone: 503-207-2066
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Portsmouth, New Hampshire 03801
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Princeton, New Jersey 08540
Principal Investigator: Jeffrey Apter
Phone: 609-921-3555
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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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Rancho Mirage, California 92270
Principal Investigator: Donald Anderson
Phone: 760-464-0470
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Richmond, Virginia 23294
Principal Investigator: John Scott
Phone: 804-672-2133
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San Diego, California 92103
Principal Investigator: Stephen Thein
Phone: 619-294-4302
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San Diego, California 92123
Principal Investigator: MICHAEL PLOPPER
Phone: 858-836-8350
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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Santa Ana, California 92705
Principal Investigator: John Duffy
Phone: 714-542-3008
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Santa Clarita, California 91321
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Sarasota, Florida 34243
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Scarborough, Maine 04074
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Shaker Heights, Ohio 44122
Principal Investigator: Deborah Gould
Phone: 216-526-0843
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Sherman Oaks, California 91403
Principal Investigator: THOMAS SHIOVITZ
Phone: 818-990-2671
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Springfield, New Jersey 07081
Principal Investigator: Michelle Papka
Phone: 973-850-4622
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Stamford, Connecticut 06905
Principal Investigator: Peter McAllister
Phone: 203-914-1903
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Staten Island, New York 10312
Principal Investigator: Mark DiBuono
Phone: 718-317-5522
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Sun City, Arizona 85351
Principal Investigator: Edward Zamrini
Phone: 623-832-6530
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Tampa, Florida 33609
Principal Investigator: SUSAN STEEN
Phone: 813-353-9613
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Toms River, New Jersey 08755
Principal Investigator: Sanjiv Sharma
Phone: 732-341-9500
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Toms River, New Jersey 08755
Principal Investigator: Ashok Patel
Phone: 732-244-2299
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Topeka, Kansas 66606
Principal Investigator: Scott Teeter
Phone: 785-368-0719
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Tucson, Arizona 85724
Principal Investigator: GEOFFREY AHERN
Phone: 520-626-6524
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Valencia, California 91355
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West Palm Beach, Florida 33407
Principal Investigator: Carl Sadowsky
Phone: 561-845-0500
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Winfield, Illinois 60190
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Winston-Salem, North Carolina 27103
Principal Investigator: Giles Crowell
Phone: 336-768-8062
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