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 |
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.
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
sites
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
Click here to add this to my saved trials
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
Click here to add this to my saved trials
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
Click here to add this to my saved trials
Click here to add this to my saved trials
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
Click here to add this to my saved trials
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
University of South Florida The University of South Florida is a high-impact, global research university...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
McLean Hospital McLean Hospital is a comprehensive psychiatric hospital committed to providing easy access to...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
1 Boston Medical Center Place
Boston, Massachusetts 02118
Boston, Massachusetts 02118
617.638.8000
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
340 W 10th St #6200
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(317) 274-3772
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
Click here to add this to my saved trials
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
Click here to add this to my saved trials
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
Click here to add this to my saved trials
Click here to add this to my saved trials
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials