Alzheimer's Disease Clinical Trial
— EXPEDITION 3Official title:
Effect of Passive Immunization on the Progression of Mild Alzheimer's Disease: Solanezumab (LY2062430) Versus Placebo
| Verified date | September 2019 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 2129 |
| Est. completion date | February 2017 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 55 Years to 90 Years |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| Australia | 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. | Box Hill | Victoria |
| Australia | 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. | Caulfield | Victoria |
| Australia | 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. | Darlinghurst | New South Wales |
| Australia | 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. | East Gosford | New South Wales |
| Australia | 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. | Fitzroy | Victoria |
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| Australia | 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. | Subiaco | Western Australia |
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| United States | Albany Medical College | Albany | New York |
| United States | Albuquerque Neurosciences | Albuquerque | New Mexico |
| United States | Dent Neurological Institute | Amherst | New York |
| United States | Atlanta Center of Medical Research | Atlanta | Georgia |
| United States | Maine Research Associates | Auburn | Maine |
| United States | PharmaSite Research Inc | Baltimore | Maryland |
| United States | McLean Hospital | Belmont | Massachusetts |
| United States | The Memory Clinic | Bennington | Vermont |
| United States | Parkinson's Disease and Movement Disorders | Boca Raton | Florida |
| United States | Boston University Medical Center | Boston | Massachusetts |
| United States | Brigham and Womens Hospital | Boston | Massachusetts |
| United States | SPRI Clinical Trials, LLC. | Brooklyn | New York |
| United States | American Neuropsychiatric Research Institute, Inc | Carson | California |
| United States | Valley Medical Research | Centerville | Ohio |
| United States | Roper St. Francis Healthcare | Charleston | South Carolina |
| United States | Behavioral Health Center Research | Charlotte | North Carolina |
| United States | PMG Research of Charlotte, LLC | Charlotte | North Carolina |
| United States | Rush Alzheimer's Disease Center | Chicago | Illinois |
| United States | Ohio State Univ College Of Medicine | Columbus | Ohio |
| United States | The Corvallis Clinic P.C. | Corvallis | Oregon |
| United States | Texas Neurology, PA | Dallas | Texas |
| United States | University of Texas Southwestern Medical Center at Dallas | Dallas | Texas |
| United States | Neurology Specialists Inc. | Dayton | Ohio |
| United States | Quantum Laboratories | Deerfield Beach | Florida |
| United States | Brain Matters Research | Delray Beach | Florida |
| United States | Cohen Medical Associates P.A. | Delray Beach | Florida |
| United States | Radiant Research | Denver | Colorado |
| United States | Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island |
| United States | Alexian Brothers Medical Center | Elk Grove Village | Illinois |
| United States | Associated Neurologists of Southern Connecticut | Fairfield | Connecticut |
| United States | Neuropsychiatric Research Center of Southwest Florida | Fort Myers | Florida |
| United States | Neurology Center of North Orange County | Fullerton | California |
| United States | Guilford Neurologic Associates | Greensboro | North Carolina |
| United States | Radiant Research | Greer | South Carolina |
| United States | MD Clinical | Hallandale Beach | Florida |
| United States | Hattiesburg Clinic | Hattiesburg | Mississippi |
| United States | Galiz Research | Hialeah | Florida |
| United States | Infinity Clinical Research . LLC | Hollywood | Florida |
| United States | Indiana University School of Medicine | Indianapolis | Indiana |
| United States | Institute for Memory Impairment & Neurological Disorders | Irvine | California |
| United States | Jacksonville Center for Clinical Research | Jacksonville | Florida |
| United States | Mayo Clinic of Jacksonville | Jacksonville | Florida |
| United States | Quillen College of Medicine, East TN State University | Johnson City | Tennessee |
| United States | University of Kansas Medical Center | Kansas City | Kansas |
| United States | University of California - San Diego | La Jolla | California |
| United States | Senior Clinical Trials, Inc. | Laguna Hills | California |
| United States | Cleveland Clinic of Las Vegas | Las Vegas | Nevada |
| United States | Las Vegas Radiology | Las Vegas | Nevada |
| United States | AdvanceMed Research | Lawrenceville | New Jersey |
| United States | Baptist Physician's Lexington | Lexington | Kentucky |
| United States | Torrance Clinical Research | Lomita | California |
| United States | Apostle Clinical Trials, Inc | Long Beach | California |
| United States | Collaborative Neuroscience Network - CNS | Long Beach | California |
| United States | UCLA Medical Center | Los Angeles | California |
| United States | Univ of Southern California Medical Center | Los Angeles | California |
| United States | University of California Los Angeles School of Medicine | Los Angeles | California |
| United States | ActivMed Practices & Research, Inc | Methuen | Massachusetts |
| United States | Miami Jewish Home and Hospital for the Aged | Miami | Florida |
| United States | Radiant Research | Murray | Utah |
| United States | Vanderbilt Univeristy School of Medicine | Nashville | Tennessee |
| United States | Institute for Neurodegenerative Disorders | New Haven | Connecticut |
| United States | Yale University School of Medicine | New Haven | Connecticut |
| United States | Columbia University Medical Center | New York | New York |
| United States | Mount Sinai Medical Center | New York | New York |
| United States | New York University Medical Center | New York | New York |
| United States | Christiana Care Research Institute | Newark | Delaware |
| United States | Hoag Memorial Hospital | Newport Beach | California |
| United States | Boston Center for Memory | Newton | Massachusetts |
| United States | National Clinical Research - Norfolk Inc | Norfolk | Virginia |
| United States | Research Center for Clinical Studies | Norwalk | Connecticut |
| United States | Renstar Medical Research | Ocala | Florida |
| United States | Cutting Edge Research Group | Oklahoma City | Oklahoma |
| United States | Red River Medical Center, LLC | Oklahoma City | Oklahoma |
| United States | Univ of Nebraska Med Center | Omaha | Nebraska |
| United States | Compass Research | Orlando | Florida |
| United States | Pacific Neuroscience Medical Group | Oxnard | California |
| United States | Drexel University College of Medicine at EPPI | Philadelphia | Pennsylvania |
| United States | Banner Alzheimer's Institute | Phoenix | Arizona |
| United States | St Josephs Hospital and Medical Center | Phoenix | Arizona |
| United States | Xenoscience | Phoenix | Arizona |
| United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
| United States | Summit Research Network Inc | Portland | Oregon |
| United States | CTT Consultants | Prairie Village | Kansas |
| United States | Butler Hospital | Providence | Rhode Island |
| United States | Rhode Island Hospital | Providence | Rhode Island |
| United States | Wake Research Associates | Raleigh | North Carolina |
| United States | Anderson Clinical Research | Redlands | California |
| United States | National Clinical Research - Richmond | Richmond | Virginia |
| United States | Blue Ridge Research Center | Roanoke | Virginia |
| United States | University of California, Davis - Health Systems | Sacramento | California |
| United States | University of Utah School of Medicine | Salt Lake City | Utah |
| United States | Diagnostic Research Group | San Antonio | Texas |
| United States | Artemis Institute for Clinical Research | San Diego | California |
| United States | Pacific Research Network Inc | San Diego | California |
| United States | Sharp Mesa Vista Hospital | San Diego | California |
| United States | San Francisco Clinical Research Center | San Francisco | California |
| United States | University of California, San Francisco | San Francisco | California |
| United States | Apex Research Institute | Santa Ana | California |
| United States | St. Joseph Health | Santa Rosa | California |
| United States | Maine Neurology | Scarborough | Maine |
| United States | Veterans Affairs Puget Sound Health Care System | Seattle | Washington |
| United States | Insight Clinical Trials | Shaker Heights | Ohio |
| United States | California Neuroscience Research | Sherman Oaks | California |
| United States | Private Office: J. Gary Booker | Shreveport | Louisiana |
| United States | University Psychiatry Associates Avera Health | Sioux Falls | South Dakota |
| United States | Richmond Behavorial Associates | Staten Island | New York |
| United States | ANI Arizona Neurological Institute Research, PC | Sun City | Arizona |
| United States | Banner Sun Health Research Institute | Sun City | Arizona |
| United States | Neurology Clinical Research, Inc | Sunrise | Florida |
| United States | Axiom Research | Tampa | Florida |
| United States | Stedman Clinical Trials | Tampa | Florida |
| United States | University of South Florida | Tampa | Florida |
| United States | Northern Michigan Neurology | Traverse City | Michigan |
| United States | Arizona Health Sciences Center | Tucson | Arizona |
| United States | Center for Neurosciences | Tucson | Arizona |
| United States | Georgetown University Hospital | Washington | District of Columbia |
| United States | Premiere Research Institute at Palm Beach Neurology | West Palm Beach | Florida |
| United States | Heartland Research Associates | Wichita | Kansas |
| United States | Via Christi Regional Medical Center | Wichita | Kansas |
| United States | PMG Research of Winston-Salem, LLC | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Australia, Canada, France, Germany, Italy, Japan, Poland, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Baseline, Week 80 | |
| Secondary | 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. | Baseline, Week 80 | |
| Secondary | 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. | Baseline, Week 80 | |
| Secondary | 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. | Baseline, Week 80 | |
| Secondary | Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) | 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. | Baseline, Week 80 | |
| Secondary | 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. | Baseline, Week 80 | |
| Secondary | 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. | Baseline, Week 80 | |
| Secondary | 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. | Baseline, Week 80 | |
| Secondary | 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. | Baseline, Week 80 | |
| Secondary | 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. | Baseline, Week 80 | |
| Secondary | 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. | Baseline, Week 80 | |
| Secondary | 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. | Baseline, Week 80 | |
| Secondary | 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. | Baseline through Week 80 | |
| Secondary | Change From Baseline in Plasma Amyloid-Beta (Aß) Species | Concentration of amino acid peptide known as Aß 1-42 in plasma. The change in plasma Aß analytes after treatment were assessed separately for each plasma Aß parameter. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. | Baseline, Week 80 | |
| Secondary | 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. | Baseline, Week 80 | |
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Solanezumab (LY2062430) | Area Under the Concentration versus Time Curve was evaluated for Solanezumab. | 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 | |
| Secondary | 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. | Baseline, Week 80 | |
| Secondary | Change From Baseline in Cerebrospinal Fluid (CSF) Aß Levels | Concentration of CSF parameters includes amino acid peptide known as Aß 1-42 and Aß 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. | Baseline, Week 80 |
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