Back to results

Progress of Mild Alzheimer's Disease in Participants on Solanezumab Versus Placebo (EXPEDITION 3)

Primary Purpose

Alzheimer's Disease

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Solanezumab

Placebo

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Xenoscience
Banner Alzheimer's Institute
St Josephs Hospital and Medical Center
ANI Arizona Neurological Institute Research, PC
Banner Sun Health Research Institute
Center for Neurosciences
Arizona Health Sciences Center
American Neuropsychiatric Research Institute, Inc
Neurology Center of North Orange County
Institute for Memory Impairment & Neurological Disorders
University of California - San Diego
Senior Clinical Trials, Inc.
Torrance Clinical Research
Collaborative Neuroscience Network - CNS
Apostle Clinical Trials, Inc
Univ of Southern California Medical Center
University of California Los Angeles School of Medicine
UCLA Medical Center
Hoag Memorial Hospital
Pacific Neuroscience Medical Group
Anderson Clinical Research
University of California, Davis - Health Systems
Artemis Institute for Clinical Research
Pacific Research Network Inc
Sharp Mesa Vista Hospital
San Francisco Clinical Research Center
University of California, San Francisco
Apex Research Institute
St. Joseph Health
California Neuroscience Research
Radiant Research
Associated Neurologists of Southern Connecticut
Institute for Neurodegenerative Disorders
Yale University School of Medicine
Research Center for Clinical Studies
Christiana Care Research Institute
Georgetown University Hospital
Parkinson's Disease and Movement Disorders
Quantum Laboratories
Brain Matters Research
Cohen Medical Associates P.A.
Neuropsychiatric Research Center of Southwest Florida
MD Clinical
Galiz Research
Infinity Clinical Research . LLC
Jacksonville Center for Clinical Research
Mayo Clinic of Jacksonville
Miami Jewish Home and Hospital for the Aged
Renstar Medical Research
Compass Research
Neurology Clinical Research, Inc
Axiom Research
Stedman Clinical Trials
University of South Florida
Premiere Research Institute at Palm Beach Neurology
Atlanta Center of Medical Research
Rush Alzheimer's Disease Center
Alexian Brothers Medical Center
Indiana University School of Medicine
University of Kansas Medical Center
CTT Consultants
Heartland Research Associates
Via Christi Regional Medical Center
Baptist Physician's Lexington
Private Office: J. Gary Booker
Maine Research Associates
Maine Neurology
PharmaSite Research Inc
McLean Hospital
Brigham and Womens Hospital
Boston University Medical Center
ActivMed Practices & Research, Inc
Boston Center for Memory
Northern Michigan Neurology
Hattiesburg Clinic
Univ of Nebraska Med Center
Cleveland Clinic of Las Vegas
Las Vegas Radiology
AdvanceMed Research
Albuquerque Neurosciences
Albany Medical College
Dent Neurological Institute
SPRI Clinical Trials, LLC.
New York University Medical Center
Mount Sinai Medical Center
Columbia University Medical Center
Richmond Behavorial Associates
PMG Research of Charlotte, LLC
Behavioral Health Center Research
Guilford Neurologic Associates
Wake Research Associates
PMG Research of Winston-Salem, LLC
Valley Medical Research
Ohio State Univ College Of Medicine
Neurology Specialists Inc.
Insight Clinical Trials
Red River Medical Center, LLC
Cutting Edge Research Group
The Corvallis Clinic P.C.
Summit Research Network Inc
Drexel University College of Medicine at EPPI
University of Pittsburgh Medical Center
Rhode Island Mood & Memory Research Institute
Rhode Island Hospital
Butler Hospital
Roper St. Francis Healthcare
Radiant Research
University Psychiatry Associates Avera Health
Quillen College of Medicine, East TN State University
Vanderbilt Univeristy School of Medicine
Texas Neurology, PA
University of Texas Southwestern Medical Center at Dallas
Diagnostic Research Group
Radiant Research
University of Utah School of Medicine
The Memory Clinic
National Clinical Research - Norfolk Inc
National Clinical Research - Richmond
Blue Ridge Research Center
Veterans Affairs Puget Sound Health Care System
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Solanezumab

Placebo

Arm Description

Solanezumab 400 milligrams (mg) every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.

Placebo every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 14 Item Subscore (ADAS-Cog14)

The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS that was used as the primary efficacy measure consists of 14 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze completion measures. The ADAS-Cog14 scale ranges from 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

Secondary Outcome Measures

Change From Baseline in Alzheimer's Disease Cooperative Study- Instrumental Activities of Daily Living (ADCS-iADL)

The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 11 Item Subscore (ADAS-Cog11)

The cognitive subscale of ADAS (ADAS Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

Change From Baseline in Mini-Mental State Examination (MMSE)

MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges from 0 to 30; lower score indicates greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)

Change From Baseline in Functional Activities Questionnaire (FAQ)

FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from financial management, shopping, playing games, food preparation, traveling, keeping appointments, keeping track of current events, and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. A negative change indicated an improvement from baseline. FAQ Total Score is the sum of 10 items, ranging from 0 (best possible outcome) to 100 (worst possible outcome). LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB)

CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

Change From Baseline in Neuropsychiatric Inventory (NPI)

NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. Total score ranges from 12 to 144; Higher scores indicate greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite)

Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (care-giving time, work status) and participants (accommodation and healthcare resource utilization) was gathered from baseline and follow-up interviews. Reported number of hospitalizations per participant up to 76 weeks. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD)

Assesses QoL for AD: participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items, rated on a 4-point scale. Sum of items=total score (range: 13 to 52). Higher scores indicate greater QoL. Participant's primary caregiver asked to complete same measure. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

Change From Baseline in 5-Dimensional EuroQol Quality of Life Scale Proxy Version (EQ-5D Proxy)

EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 severity levels: no, some, severe problems. Visual analog scale (VAS) assesses caregiver's impression of participant's health state; score ranges: 0 to 100 millimeter (mm). Lower scores=greater disease severity LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS)

Integrated Alzheimer's Disease Rating Scale is used to assess that solanezumab slows down the cognitive and functional decline associated with AD compared with placebo. iADRS is a simple linear combination of ADAS-Cog 13 or 14 and the ADCS-iADL. The scale ranges from 0 to 146, where lower scores indicate worse performance. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

Percentage of Participants of Cognitive and Functional Responders

Assess the proportion of participants who reach certain levels of cognitive and functional decline. Decline in cognition was defined as worsening from baseline by at least 6 or 9 points on the ADAS Cog14. If there is a cognitive decline of a specified cut-off or more at any time then the participant is considered a nonresponder. Functional nonresponders are participants who have not had any of the following at any time point: Clinically evident decline in ability to perform one or more basic ADL present at baseline; A clinically evident decline in ability to perform 20% or more of the instrumental ADL present at baseline; An increase in global CDR score of 1 point or more compared with baseline. A decline from no impairment to mild impairment (bADL, iADL is not considered clinically significant, but other declines of 1 or more points and any participant discontinuation within the first 6 months will be considered a non-responder.

Change From Baseline in Plasma Amyloid-Beta (Aβ) Species

Concentration of amino acid peptide known as Aβ 1-42 in plasma. The change in plasma Aβ analytes after treatment were assessed separately for each plasma Aβ parameter. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)

The vMRI assessment of right and left hippocampal atrophy, is reported. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Solanezumab (LY2062430)

Area Under the Concentration versus Time Curve was evaluated for Solanezumab.

Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan

Florbetapir PET imaging was used to confirm the presence of amyloid pathology consistent with AD. Change from baseline was done to test the hypothesis that amyloid burden was reduced in participants in the treatment group. The change from baseline to the postbaseline visit of the composite summary standard uptake value ratio of florbetapir F18 was calculated. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. The composite summary measure is an unweighted average of the 6 smaller regions (anterior cingulate, frontal medial orbital, parietal, posterior cingulate, precuneus, and temporal) normalized to whole cerebellum or subject-specific white matter.

Change From Baseline in Cerebrospinal Fluid (CSF) Aβ Levels

Concentration of CSF parameters includes amino acid peptide known as Aβ 1-42 and Aβ 1-42. Analyses of these CSF biomarkers was conducted in a subset of participants (as an addendum to the protocol). The dependent variable for each CSF parameter was its change from baseline to endpoint. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

Full Information

NCT ID

NCT01900665

First Posted

July 12, 2013

Last Updated

September 25, 2019

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01900665

Brief Title

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

Acronym

EXPEDITION 3

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Terminated

Why Stopped

Solanezumab did not meet the study's primary endpoint.

Study Start Date

July 2013 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2129 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Solanezumab

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Solanezumab

Other Intervention Name(s)

LY2062430, A Beta Antibody

Intervention Description

Administered Intravenously (IV)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered IV

Primary Outcome Measure Information:

Title

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 14 Item Subscore (ADAS-Cog14)

Description

Time Frame

Baseline, Week 80

Secondary Outcome Measure Information:

Title

Change From Baseline in Alzheimer's Disease Cooperative Study- Instrumental Activities of Daily Living (ADCS-iADL)

Description

Time Frame

Baseline, Week 80

Title

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 11 Item Subscore (ADAS-Cog11)

Description

Time Frame

Baseline, Week 80

Title

Change From Baseline in Mini-Mental State Examination (MMSE)

Description

Time Frame

Baseline, Week 80

Title

Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)

Description

Time Frame

Baseline, Week 80

Title

Change From Baseline in Functional Activities Questionnaire (FAQ)

Description

Time Frame

Baseline, Week 80

Title

Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB)

Description

Time Frame

Baseline, Week 80

Title

Change From Baseline in Neuropsychiatric Inventory (NPI)

Description

Time Frame

Baseline, Week 80

Title

Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite)

Description

Time Frame

Baseline, Week 80

Title

Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD)

Description

Time Frame

Baseline, Week 80

Title

Change From Baseline in 5-Dimensional EuroQol Quality of Life Scale Proxy Version (EQ-5D Proxy)

Description

Time Frame

Baseline, Week 80

Title

Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS)

Description

Time Frame

Baseline, Week 80

Title

Percentage of Participants of Cognitive and Functional Responders

Description

Time Frame

Baseline through Week 80

Title

Change From Baseline in Plasma Amyloid-Beta (Aβ) Species

Description

Time Frame

Baseline, Week 80

Title

Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)

Description

The vMRI assessment of right and left hippocampal atrophy, is reported. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

Time Frame

Baseline, Week 80

Title

Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Solanezumab (LY2062430)

Description

Area Under the Concentration versus Time Curve was evaluated for Solanezumab.

Time Frame

Visit 2 (Post-dose), Visit 5, 9, 15 (Pre-dose, Post-dose) and Visit 22 (Pre-dose): Pre-dose before the infusion, Post-dose 30 minutes End of Infusion

Title

Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan

Description

Time Frame

Baseline, Week 80

Title

Change From Baseline in Cerebrospinal Fluid (CSF) Aβ Levels

Description

Time Frame

Baseline, Week 80

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Xenoscience

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85004

Country

United States

Facility Name

Banner Alzheimer's Institute

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

Facility Name

St Josephs Hospital and Medical Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85013

Country

United States

Facility Name

ANI Arizona Neurological Institute Research, PC

City

Sun City

State/Province

Arizona

ZIP/Postal Code

85351

Country

United States

Facility Name

Banner Sun Health Research Institute

City

Sun City

State/Province

Arizona

ZIP/Postal Code

85351

Country

United States

Facility Name

Center for Neurosciences

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85718

Country

United States

Facility Name

Arizona Health Sciences Center

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

American Neuropsychiatric Research Institute, Inc

City

Carson

State/Province

California

ZIP/Postal Code

90746

Country

United States

Facility Name

Neurology Center of North Orange County

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Institute for Memory Impairment & Neurological Disorders

City

Irvine

State/Province

California

ZIP/Postal Code

92697

Country

United States

Facility Name

University of California - San Diego

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Senior Clinical Trials, Inc.

City

Laguna Hills

State/Province

California

ZIP/Postal Code

92653

Country

United States

Facility Name

Torrance Clinical Research

City

Lomita

State/Province

California

ZIP/Postal Code

90717

Country

United States

Facility Name

Collaborative Neuroscience Network - CNS

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Apostle Clinical Trials, Inc

City

Long Beach

State/Province

California

ZIP/Postal Code

90813

Country

United States

Facility Name

Univ of Southern California Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

University of California Los Angeles School of Medicine

City

Los Angeles

State/Province

California

ZIP/Postal Code

90073

Country

United States

Facility Name

UCLA Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Hoag Memorial Hospital

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

Pacific Neuroscience Medical Group

City

Oxnard

State/Province

California

ZIP/Postal Code

93030

Country

United States

Facility Name

Anderson Clinical Research

City

Redlands

State/Province

California

ZIP/Postal Code

92374

Country

United States

Facility Name

University of California, Davis - Health Systems

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Artemis Institute for Clinical Research

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Pacific Research Network Inc

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Sharp Mesa Vista Hospital

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

San Francisco Clinical Research Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94109

Country

United States

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94158

Country

United States

Facility Name

Apex Research Institute

City

Santa Ana

State/Province

California

ZIP/Postal Code

92705

Country

United States

Facility Name

St. Joseph Health

City

Santa Rosa

State/Province

California

ZIP/Postal Code

95403

Country

United States

Facility Name

California Neuroscience Research

City

Sherman Oaks

State/Province

California

ZIP/Postal Code

91403

Country

United States

Facility Name

Radiant Research

City

Denver

State/Province

Colorado

ZIP/Postal Code

80239

Country

United States

Facility Name

Associated Neurologists of Southern Connecticut

City

Fairfield

State/Province

Connecticut

ZIP/Postal Code

06824

Country

United States

Facility Name

Institute for Neurodegenerative Disorders

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

Yale University School of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520-8020

Country

United States

Facility Name

Research Center for Clinical Studies

City

Norwalk

State/Province

Connecticut

ZIP/Postal Code

06851

Country

United States

Facility Name

Christiana Care Research Institute

City

Newark

State/Province

Delaware

ZIP/Postal Code

19713

Country

United States

Facility Name

Georgetown University Hospital

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20057

Country

United States

Facility Name

Parkinson's Disease and Movement Disorders

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

Quantum Laboratories

City

Deerfield Beach

State/Province

Florida

ZIP/Postal Code

33064

Country

United States

Facility Name

Brain Matters Research

City

Delray Beach

State/Province

Florida

ZIP/Postal Code

33445

Country

United States

Facility Name

Cohen Medical Associates P.A.

City

Delray Beach

State/Province

Florida

ZIP/Postal Code

33446

Country

United States

Facility Name

Neuropsychiatric Research Center of Southwest Florida

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33912

Country

United States

Facility Name

MD Clinical

City

Hallandale Beach

State/Province

Florida

ZIP/Postal Code

33009

Country

United States

Facility Name

Galiz Research

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

Infinity Clinical Research . LLC

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

Jacksonville Center for Clinical Research

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Mayo Clinic of Jacksonville

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

Miami Jewish Home and Hospital for the Aged

City

Miami

State/Province

Florida

ZIP/Postal Code

33137

Country

United States

Facility Name

Renstar Medical Research

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Compass Research

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Neurology Clinical Research, Inc

City

Sunrise

State/Province

Florida

ZIP/Postal Code

33351-6637

Country

United States

Facility Name

Axiom Research

City

Tampa

State/Province

Florida

ZIP/Postal Code

33609

Country

United States

Facility Name

Stedman Clinical Trials

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

University of South Florida

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Premiere Research Institute at Palm Beach Neurology

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

Atlanta Center of Medical Research

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30331

Country

United States

Facility Name

Rush Alzheimer's Disease Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Alexian Brothers Medical Center

City

Elk Grove Village

State/Province

Illinois

ZIP/Postal Code

60007

Country

United States

Facility Name

Indiana University School of Medicine

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

CTT Consultants

City

Prairie Village

State/Province

Kansas

ZIP/Postal Code

66206

Country

United States

Facility Name

Heartland Research Associates

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

Country

United States

Facility Name

Via Christi Regional Medical Center

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

Baptist Physician's Lexington

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

Private Office: J. Gary Booker

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71104

Country

United States

Facility Name

Maine Research Associates

City

Auburn

State/Province

Maine

ZIP/Postal Code

04210

Country

United States

Facility Name

Maine Neurology

City

Scarborough

State/Province

Maine

ZIP/Postal Code

04074

Country

United States

Facility Name

PharmaSite Research Inc

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21208

Country

United States

Facility Name

McLean Hospital

City

Belmont

State/Province

Massachusetts

ZIP/Postal Code

02478

Country

United States

Facility Name

Brigham and Womens Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Boston University Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Facility Name

ActivMed Practices & Research, Inc

City

Methuen

State/Province

Massachusetts

ZIP/Postal Code

01844

Country

United States

Facility Name

Boston Center for Memory

City

Newton

State/Province

Massachusetts

ZIP/Postal Code

02459

Country

United States

Facility Name

Northern Michigan Neurology

City

Traverse City

State/Province

Michigan

ZIP/Postal Code

49684

Country

United States

Facility Name

Hattiesburg Clinic

City

Hattiesburg

State/Province

Mississippi

ZIP/Postal Code

39401

Country

United States

Facility Name

Univ of Nebraska Med Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

Facility Name

Cleveland Clinic of Las Vegas

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

Las Vegas Radiology

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89113

Country

United States

Facility Name

AdvanceMed Research

City

Lawrenceville

State/Province

New Jersey

ZIP/Postal Code

08648

Country

United States

Facility Name

Albuquerque Neurosciences

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87109

Country

United States

Facility Name

Albany Medical College

City

Albany

State/Province

New York

ZIP/Postal Code

12206

Country

United States

Facility Name

Dent Neurological Institute

City

Amherst

State/Province

New York

ZIP/Postal Code

14226

Country

United States

Facility Name

SPRI Clinical Trials, LLC.

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11235

Country

United States

Facility Name

New York University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Mount Sinai Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10029-6574

Country

United States

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Richmond Behavorial Associates

City

Staten Island

State/Province

New York

ZIP/Postal Code

10312

Country

United States

Facility Name

PMG Research of Charlotte, LLC

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28203

Country

United States

Facility Name

Behavioral Health Center Research

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28211

Country

United States

Facility Name

Guilford Neurologic Associates

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27405

Country

United States

Facility Name

Wake Research Associates

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

PMG Research of Winston-Salem, LLC

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Valley Medical Research

City

Centerville

State/Province

Ohio

ZIP/Postal Code

45459

Country

United States

Facility Name

Ohio State Univ College Of Medicine

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Neurology Specialists Inc.

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45417

Country

United States

Facility Name

Insight Clinical Trials

City

Shaker Heights

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Red River Medical Center, LLC

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Cutting Edge Research Group

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73116

Country

United States

Facility Name

The Corvallis Clinic P.C.

City

Corvallis

State/Province

Oregon

ZIP/Postal Code

97330

Country

United States

Facility Name

Summit Research Network Inc

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Drexel University College of Medicine at EPPI

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19102

Country

United States

Facility Name

University of Pittsburgh Medical Center

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Rhode Island Mood & Memory Research Institute

City

East Providence

State/Province

Rhode Island

ZIP/Postal Code

02914

Country

United States

Facility Name

Rhode Island Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

Butler Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02906

Country

United States

Facility Name

Roper St. Francis Healthcare

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29401

Country

United States

Facility Name

Radiant Research

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

University Psychiatry Associates Avera Health

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57105

Country

United States

Facility Name

Quillen College of Medicine, East TN State University

City

Johnson City

State/Province

Tennessee

ZIP/Postal Code

37604

Country

United States

Facility Name

Vanderbilt Univeristy School of Medicine

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212

Country

United States

Facility Name

Texas Neurology, PA

City

Dallas

State/Province

Texas

ZIP/Postal Code

75214

Country

United States

Facility Name

University of Texas Southwestern Medical Center at Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Diagnostic Research Group

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Radiant Research

City

Murray

State/Province

Utah

ZIP/Postal Code

84123

Country

United States

Facility Name

University of Utah School of Medicine

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84108

Country

United States

Facility Name

The Memory Clinic

City

Bennington

State/Province

Vermont

ZIP/Postal Code

05201

Country

United States

Facility Name

National Clinical Research - Norfolk Inc

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

National Clinical Research - Richmond

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

Blue Ridge Research Center

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24018

Country

United States

Facility Name

Veterans Affairs Puget Sound Health Care System

City

Seattle

State/Province

Washington

ZIP/Postal Code

98108

Country

United States

Facility Name

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

Darlinghurst

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

City

East Gosford

State/Province

New South Wales

ZIP/Postal Code

2250

Country

Australia

Facility Name

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

City

Caulfield

State/Province

Victoria

ZIP/Postal Code

3162

Country

Australia

Facility Name

City

Fitzroy

State/Province

Victoria

ZIP/Postal Code

3065

Country

Australia

Facility Name

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3081

Country

Australia

Facility Name

City

Subiaco

State/Province

Western Australia

ZIP/Postal Code

06008

Country

Australia

Facility Name

City

London

State/Province

Ontario

ZIP/Postal Code

N6C 5J1

Country

Canada

Facility Name

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1N 5C8

Country

Canada

Facility Name

City

Peterborough

State/Province

Ontario

ZIP/Postal Code

K9H2P4

Country

Canada

Facility Name

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4G 3E8

Country

Canada

Facility Name

City

Gatineau

State/Province

Quebec

ZIP/Postal Code

J8T 8J1

Country

Canada

Facility Name

City

Greenfield Park

State/Province

Quebec

Country

Canada

Facility Name

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H1Z1

Country

Canada

Facility Name

City

Bron

ZIP/Postal Code

69677

Country

France

Facility Name

City

Dijon

ZIP/Postal Code

21033

Country

France

Facility Name

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

City

Marseille

ZIP/Postal Code

13385

Country

France

Facility Name

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Name

City

Reims

ZIP/Postal Code

51092

Country

France

Facility Name

City

Rennes

ZIP/Postal Code

35033

Country

France

Facility Name

City

Strasbourg

ZIP/Postal Code

67098

Country

France

Facility Name

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

City

Villeurbanne

ZIP/Postal Code

69100

Country

France

Facility Name

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

City

Boeblingen

ZIP/Postal Code

71034

Country

Germany

Facility Name

City

Hannover

ZIP/Postal Code

30559

Country

Germany

Facility Name

City

Mannheim

ZIP/Postal Code

68165

Country

Germany

Facility Name

City

Munich

ZIP/Postal Code

81675

Country

Germany

Facility Name

City

Siegen

ZIP/Postal Code

57076

Country

Germany

Facility Name

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

City

Westerstede

ZIP/Postal Code

26655

Country

Germany

Facility Name

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Facility Name

City

Genova

ZIP/Postal Code

16128

Country

Italy

Facility Name

City

Milano

ZIP/Postal Code

20122

Country

Italy

Facility Name

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Facility Name

City

Ponderano (BI)

ZIP/Postal Code

13875

Country

Italy

Facility Name

City

Rome

ZIP/Postal Code

00161

Country

Italy

Facility Name

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

City

Aichi

ZIP/Postal Code

474-8511

Country

Japan

Facility Name

City

Hyogo

ZIP/Postal Code

670-0981

Country

Japan

Facility Name

City

Ibaraki

ZIP/Postal Code

305-8576

Country

Japan

Facility Name

City

Kanagawa

ZIP/Postal Code

247-8533

Country

Japan

Facility Name

City

Kobe

ZIP/Postal Code

655-0037

Country

Japan

Facility Name

City

Kyoto

ZIP/Postal Code

616-8255

Country

Japan

Facility Name

City

Osaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

City

Shizuoka

ZIP/Postal Code

424-8636

Country

Japan

Facility Name

City

Tokushima

ZIP/Postal Code

770-8503

Country

Japan

Facility Name

City

Tokyo

ZIP/Postal Code

187-8551

Country

Japan

Facility Name

City

Bydgoszcz

ZIP/Postal Code

85-796

Country

Poland

Facility Name

City

Katowice

ZIP/Postal Code

40-588

Country

Poland

Facility Name

City

Krakow

ZIP/Postal Code

31-505

Country

Poland

Facility Name

City

Sopot

ZIP/Postal Code

81-824

Country

Poland

Facility Name

City

Szczecin

ZIP/Postal Code

70-215

Country

Poland

Facility Name

City

Warsaw

ZIP/Postal Code

01-813

Country

Poland

Facility Name

City

Barakaldo

ZIP/Postal Code

48903

Country

Spain

Facility Name

City

Barcelona

ZIP/Postal Code

08014

Country

Spain

Facility Name

City

Getafe

ZIP/Postal Code

28905

Country

Spain

Facility Name

City

Guipuzcoa

ZIP/Postal Code

20014

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

City

Plasencia

ZIP/Postal Code

10600

Country

Spain

Facility Name

City

Salt-Girona

ZIP/Postal Code

17190

Country

Spain

Facility Name

City

Jönköping

ZIP/Postal Code

55185

Country

Sweden

Facility Name

City

Malmo

ZIP/Postal Code

212 24

Country

Sweden

Facility Name

City

Molndal

ZIP/Postal Code

431 41

Country

Sweden

Facility Name

City

Stockholm

ZIP/Postal Code

14186

Country

Sweden

Facility Name

City

Umea

ZIP/Postal Code

90185

Country

Sweden

Facility Name

City

Bath

State/Province

Avon

ZIP/Postal Code

BA1 3NG

Country

United Kingdom

Facility Name

City

Plymouth

State/Province

Devon

ZIP/Postal Code

PL6 8BX

Country

United Kingdom

Facility Name

City

Crowborough

State/Province

East Sussex

ZIP/Postal Code

TN6 1HB

Country

United Kingdom

Facility Name

City

Scotland

State/Province

Glasgow

ZIP/Postal Code

G20 0XA

Country

United Kingdom

Facility Name

City

Greater London

State/Province

London

ZIP/Postal Code

W1G9JF

Country

United Kingdom

Facility Name

City

Salford

State/Province

Manchester

ZIP/Postal Code

M6 8HD

Country

United Kingdom

Facility Name

City

Swindon

State/Province

Wiltshire

ZIP/Postal Code

SN3 6BW

Country

United Kingdom

Facility Name

City

Glasgow

ZIP/Postal Code

G31 2ER

Country

United Kingdom

Facility Name

City

Newcastle

ZIP/Postal Code

NE4 5PL

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Citations:

PubMed Identifier

29365294

Citation

Honig LS, Vellas B, Woodward M, Boada M, Bullock R, Borrie M, Hager K, Andreasen N, Scarpini E, Liu-Seifert H, Case M, Dean RA, Hake A, Sundell K, Poole Hoffmann V, Carlson C, Khanna R, Mintun M, DeMattos R, Selzler KJ, Siemers E. Trial of Solanezumab for Mild Dementia Due to Alzheimer's Disease. N Engl J Med. 2018 Jan 25;378(4):321-330. doi: 10.1056/NEJMoa1705971.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs