Progress of Mild Alzheimer's Disease in Participants on Solanezumab Versus Placebo



Status:Terminated
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:55 - 90
Updated:5/5/2018
Start Date:July 2013
End Date:February 2017

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Effect of Passive Immunization on the Progression of Mild Alzheimer's Disease: Solanezumab (LY2062430) Versus Placebo

To test the idea that solanezumab will slow the cognitive decline of Alzheimer's Disease (AD)
as compared with placebo in participants with mild AD.


Inclusion Criteria:

- Meets National Institute of Neurological and Communicative Disorders and
Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria
for probable AD

- Has a Modified Hachinski Ischemia Scale score of less than or equal to 4

- Has a Mini-Mental State Examination (MMSE) score of 20 through 26 at Screening visit

- Has a Geriatric Depression Scale score of less than or equal to 6 (on the
staff-administered short form)

- Has had a magnetic resonance imaging (MRI) or computerized tomography (CT) scan
performed within the past 2 years that has confirmed no findings inconsistent with a
diagnosis of AD

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

Exclusion Criteria:

- Does not have a reliable caregiver who is in frequent contact with the participant
(defined as at least 10 hours per week), will accompany the participant to the office
and/or be available by telephone at designated times, and will monitor administration
of prescribed medications

- Meets National Institute of Neurological Disorders and Stroke/Association
Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN)
criteria for vascular dementia

- Has current serious or unstable illnesses including cardiovascular, hepatic, renal,
gastroenterologic, respiratory, endocrinologic, neurologic (other than AD),
psychiatric, immunologic, or hematologic disease and other conditions that, in the
investigator's opinion, could interfere with the analyses of safety and efficacy in
this study; or has a life expectancy of <2 years

- Has had a history within the last 5 years of a serious infectious disease affecting
the brain or head trauma resulting in protracted loss of consciousness

- Has a 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 a normal
prostate-specific antigen posttreatment

- Has a known history of human immunodeficiency virus (HIV), clinically significant
multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions

- Has received acetylcholinesterase inhibitor (AChEIs), memantine and/or other AD
therapy for less than 4 months or has less than 2 months of stable therapy on these
treatments

- Has received medications that affect the central nervous system (CNS), except
treatments for AD, for less than 4 weeks

- Has a history of chronic alcohol or drug abuse/dependence within the past 5 years

- Has a Visit 1 MRI with results showing >4 Amyloid-related Imaging Abnormality (ARIA),
-hemorrhage /hemosiderin deposition (ARIA-H) or presence of ARIA-E (edema/effusions)
We found this trial at
121
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Oklahoma City, Oklahoma 73116
153
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
1444
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
345
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911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
1313
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4085 University Blvd S # 1
Jacksonville, Florida 32216
1060
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Jacksonville, FL
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
1289
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
1078
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Ocala, FL
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
1141
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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3540 Northwest 88th Avenue
Sunrise, Florida
1299
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3212 Cove Bend Drive
Tampa, Florida 33613
1112
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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2450 E. River Road
Tucson, Arizona 85718
520-320-2147
831
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
32
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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Albuquerque, New Mexico 87109
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Amherst, New York 14226
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Auburn, Maine 04210
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Baltimore, Maryland 21208
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115 Mill St
Belmont, Massachusetts 02478
(617) 855-2000
McLean Hospital McLean Hospital is a comprehensive psychiatric hospital committed to providing easy access to...
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Bennington, Vermont 05201
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Boca Raton, Florida 33486
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1 Boston Medical Center Place
Boston, Massachusetts 02118
617.638.8000
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Brooklyn, New York 11235
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1173
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Centerville, Ohio 45459
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Charleston, South Carolina 29401
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Charlotte, North Carolina 28211
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Chicago, Illinois 60612
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Dallas, Texas 75214
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East Providence, Rhode Island 02914
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Elk Grove Village, Illinois 60007
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Fullerton, California 92835
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Greensboro, North Carolina 27405
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Hattiesburg, Mississippi 39401
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Hollywood, Florida 33021
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Laguna Hills, California 92653
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Las Vegas, Nevada 89102
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Lawrenceville, New Jersey 08648
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757 Westwood Plaza
Los Angeles, California 90024
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Methuen, Massachusetts 01844
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Murray, Utah 84123
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Nashville, Tennessee 37212
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New Haven, Connecticut 06510
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333 Cedar St
New Haven, Connecticut 06504
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630 W 168th St
New York, New York
212-305-2862
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Oklahoma City, Oklahoma 73112
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
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Philadelphia, Pennsylvania 19102
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Phoenix, Arizona 85006
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350 W Thomas Rd
Phoenix, Arizona 85013
(602) 406-3000
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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Phoenix, Arizona 85004
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
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Portland, Oregon 97210
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Prairie Village, Kansas 66206
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345 Blackstone Blvd
Providence, Rhode Island 02906
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Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Redlands, California 92374
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Roanoke, Virginia 24018
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