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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929 N St Francis St
Wichita, Kansas 67214
(316) 268-5775
Via Christi Regional Medical Center Via Christi Health's rich history of serving the people of...
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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...
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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...
911
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911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
980
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4085 University Blvd S # 1
Jacksonville, Florida 32216
673
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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...
480
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
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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...
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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
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3212 Cove Bend Drive
Tampa, Florida 33613
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
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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
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47 New Scotland Ave
Albany, New York 12208
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811 Juniper St NE
Atlanta, Georgia 30308
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115 Mill St
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Boca Raton, Florida 33486
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1 Boston Medical Center Place
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340 W 10th St #6200
Indianapolis, Indiana 46202
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3901 Rainbow Blvd
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9500 Gilman Dr
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757 Westwood Plaza
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Emile St
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350 W Thomas Rd
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200 Lothrop St
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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
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