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A4: Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02008357
Collaborator
Alzheimer's Therapeutic Research Institute (Other)
1,150
Enrollment
68
Locations
2
Arms
112
Anticipated Duration (Months)
16.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to test whether an investigational drug called solanezumab can slow the progression of memory problems associated with brain amyloid (protein that forms plaques in the brains of people with Alzheimer Disease [AD]).

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

The A4 study is a clinical trial for older individuals who have evidence of amyloid plaque build-up in their brains who may be at risk for memory loss and cognitive decline due to Alzheimer's disease. The A4 study will test an anti-amyloid investigational drug in older individuals who do not yet show symptoms of Alzheimer's disease cognitive impairment or dementia with the aim of slowing memory and cognitive decline. The A4 study will also test whether anti-amyloid treatment can delay the progression of AD related brain injury on imaging and other biomarkers.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4 Study)
Actual Study Start Date :
Feb 28, 2014
Anticipated Primary Completion Date :
Dec 29, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Solanezumab

Solanezumab (400-1600 milligrams) intravenously (IV) every 4 weeks for 240 weeks. Participants who enter the open-label extension will receive solanezumab IV.

Drug: Solanezumab
Administered IV
Other Names:
  • LY2062430

    		•
    Placebo Comparator: Placebo

    Placebo IV every 4 weeks for 240 weeks. Participants who enter the open-label extension will receive solanezumab IV.

    Drug: Placebo
    Administered IV

    Drug: Solanezumab
    Administered IV
    Other Names:
  • LY2062430

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline of the Preclinical Alzheimer Cognitive Composite (PACC) [Baseline, Week 240; Baseline, Week 336]

    Secondary Outcome Measures

    1. Change from Baseline in Cognitive Function Index (CFI) [Baseline, Week 240; Baseline, Week 336]

    2. Change from Baseline in Alzheimer's Disease Cooperative Study-Activities Daily Living-Prevention Questionnaire (ADCS-ADL-Prevention Questionnaire) Score [Baseline, Week 240; Baseline, Week 336]

    3. Change from Baseline in Mean Composite Standardized Uptake Value Ratio (SUVr) [Baseline, Week 240]

    4. Change from Baseline in Cerebrospinal Fluid (CSF) Tau Biomarkers [Baseline, Week 240]

    5. Change from Baseline of CSF Concentrations of Amyloid Beta (Abeta) [Baseline, Week 240]

    6. Change from Baseline of Volumetric Magnetic Resonance Imaging (vMRI) [Baseline, Week 240]

    7. Change from Baseline on the Clinical Dementia Rating-Sum of Boxes score (CDR-SB) [Baseline, Week 336]

    8. Change from Baseline on the Computerized Cognitive Composite (C3) [Baseline, Week 336]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Has a Mini-Mental State Examination (MMSE) score at screening of 25 to 30

    • Has a global Clinical Dementia Rating (CDR) scale score at screening of 0

    • Has a Logical Memory II score at screening of 6 to 18

    • Has a florbetapir positron emission tomography (PET) scan that shows evidence of brain amyloid pathology at screening

    • Has a study partner that is willing to participate as a source of information and has at least weekly contact with the participant (contact can be in-person, via telephone or electronic communication)

    Exclusion Criteria:

    • Is receiving a prescription acetylcholinesterase inhibitor (AChEI) and/or memantine at screening or baseline

    • Lacks good venous access, such that intravenous drug delivery or multiple blood draws would be precluded

    • Has current serious or unstable illness including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease or other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study

    • Has had a history within the last 5 years of a serious infectious disease affecting the brain (including neurosyphilis, meningitis, or encephalitis) or head trauma resulting in protracted loss of consciousness

    • Has had a history within the last 5 years of a primary or recurrent malignant disease with the exception of any in situ cancer that was appropriately treated and is being appropriately monitored, such as resected cutaneous squamous cell carcinoma in situ or in situ prostate cancer with normal prostate-specific antigen post-treatment

    • Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)

    • Is clinically judged by the investigator to be at serious risk for suicide

    • Has a history within the past 2 years of major depression or bipolar disorder as defined by the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM)

    • Has a history within the past 5 years of chronic alcohol or drug abuse/dependence as defined by the most current version of the DSM

    Open-Label Inclusion Criteria:
    • All participants who complete the placebo-controlled period will be allowed to continue into the open-label period

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294
    2 Banner Health Research Institute Phoenix Arizona United States 85006
    3 Barrow Neurological Institute Phoenix Arizona United States 85013
    4 Banner Sun Health Research Institute Sun City Arizona United States 85351
    5 Institute for Memory Impairment & Neurological Disorders Irvine California United States 92697
    6 University of California - San Diego La Jolla California United States 92037
    7 University of Southern California School of Medicine Los Angeles California United States 90033
    8 University of California - Los Angeles Los Angeles California United States 90095
    9 Univ of California Irvine College of Medicine Orange California United States 92868
    10 Veterans Affairs Medical Center Palo Alto Palo Alto California United States 94304
    11 Sutter Medical Group Sacramento California United States 95816
    12 Univ of California San Francisco San Francisco California United States 94158
    13 Syrentis Clinical Research Santa Ana California United States 92705
    14 University of California, Davis - Health Systems Walnut Creek California United States 94598
    15 Yale University School of Medicine New Haven Connecticut United States 06510
    16 Georgetown University Hospital Washington District of Columbia United States 20057
    17 Howard University Hospital Washington District of Columbia United States 20060
    18 Brain Matters Research Delray Beach Florida United States 33445
    19 Mayo Clinic-Jacksonville Jacksonville Florida United States 32224
    20 Wien Center for Clinical Research Miami Beach Florida United States 33140
    21 Compass Research - Orlando Orlando Florida United States 32806
    22 University of South Florida Tampa Florida United States 33613
    23 Compass Research -The Villages The Villages Florida United States 32162
    24 Premiere Research Institute at Palm Beach Neurology West Palm Beach Florida United States 33407
    25 Emory University Atlanta Georgia United States 30322
    26 Northwestern University Chicago Illinois United States 60611
    27 Rush Alzheimer's Disease Center Chicago Illinois United States 60612
    28 Great Lakes Clinical Trials Chicago Illinois United States 60640
    29 Indiana University School of Medicine Indianapolis Indiana United States 46202
    30 University of Iowa Iowa City Iowa United States 52242
    31 University of Kansas Hospital Fairway Kansas United States 66205
    32 University of Kentucky Lexington Kentucky United States 40504
    33 Pennington Biomedical Research Center Baton Rouge Louisiana United States 70808-4124
    34 Johns Hopkins University School of Medicine Baltimore Maryland United States 21093
    35 Brigham and Womens Hospital Boston Massachusetts United States 02115
    36 Boston University Medical Center Boston Massachusetts United States 02118
    37 University of Michigan Ann Arbor Michigan United States 48105
    38 Mayo Clinic Rochester Minnesota United States 55905
    39 Washington University School of Medicine Saint Louis Missouri United States 63110
    40 Univ of Nebraska Med Center Omaha Nebraska United States 68198
    41 Cleveland Clinic of Las Vegas Las Vegas Nevada United States 89106
    42 Dent Neurological Institute Amherst New York United States 14226
    43 New York University Medical Center New York New York United States 10016
    44 Weill Cornell Medical College New York New York United States 10021
    45 Mount Sinai School of Medicine New York New York United States 10029
    46 Columbia University Medical Center New York New York United States 10032
    47 University of Rochester Rochester New York United States 14620
    48 Wake Forest University School of Medicine Winston-Salem North Carolina United States 27157
    49 Case Western Reserve University Beachwood Ohio United States 44122
    50 Tulsa Clinical Research LLC Tulsa Oklahoma United States 74104
    51 Oregon Health and Science University Portland Oregon United States 97239
    52 Drexel University College of Medicine at EPPI Philadelphia Pennsylvania United States 19102
    53 University of Pennsylvania Hospital Philadelphia Pennsylvania United States 19104
    54 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
    55 Butler Hospital Providence Rhode Island United States 02906
    56 Rhode Island Hospital Providence Rhode Island United States 02906
    57 Roper Hospital Charleston South Carolina United States 29401
    58 University of Texas Southwestern Medical Center at Dallas Dallas Texas United States 75235
    59 Baylor College of Medicine Houston Texas United States 77030
    60 Houston Methodist Houston Texas United States 77030
    61 University of Washington School of Medicine Seattle Washington United States 98108
    62 University of Wisconsin-Madison Hospital and Health Clinic Madison Wisconsin United States 53705
    63 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. Parkville Victoria Australia 3010
    64 For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. London Canada N6C 0A7
    65 For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. Toronto Canada M3B2S7
    66 For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. Toronto Canada M4N 3M5
    67 For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. Vancouver Canada V6T 2B5
    68 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. Bunkyo-ku Japan 113-8655

    Sponsors and Collaborators

    • Eli Lilly and Company
    • Alzheimer's Therapeutic Research Institute

    Investigators

    • Study Director: 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), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT02008357
    Other Study ID Numbers:
    • 15275
    • H8A-MC-LZAZ
    First Posted:
    Dec 11, 2013
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 15, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eli Lilly and Company
    Cognition
    Prevention
    Additional relevant MeSH terms:
    Cognition Disorders

    Study Results

    No Results Posted as of Aug 19, 2022