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
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5323 Harry Hines Blvd
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911 E. Hallandale Beach Blvd
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4085 University Blvd S # 1
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1 Gustave L Levy Pl # 271
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104 SE 1st Avenue
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100 West Gore St # 202
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593 Eddy Street
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