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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Eli Lilly and Company
Sponsor:
Collaborator:
Alzheimer's Disease Cooperative Study (ADCS)
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02008357
First received: December 6, 2013
Last updated: October 2, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Cognition Disorders
Drug: Solanezumab
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4 Study)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from Baseline of the ADCS Preclinical Alzheimer Cognitive Composite (ADCS-PACC) to Week 168 [ Time Frame: Baseline, Week 168 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Cognitive Function Index (CFI) to Week 156 [ Time Frame: Baseline, Week 156 ] [ Designated as safety issue: No ]
  • Change from Baseline in Alzheimer's Disease Cooperative Study—Activities Daily Living—Prevention Questionnaire (ADCS-ADL-Prevention Questionnaire) Score to Week 156 [ Time Frame: Baseline, Week 156 ] [ Designated as safety issue: No ]
  • Change from Baseline in Mean Composite Summary Uptake Value Ratio (SUVr) to Week 168 [ Time Frame: Baseline, Week 168 ] [ Designated as safety issue: No ]
  • Change from Baseline in Cerebral Spinal Fluid (CSF) Tau Biomarkers to Week 168 [ Time Frame: Baseline, 168 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline of Cerebrospinal Fluid (CSF) Concentrations of Amyloid Beta (Abeta) to Week 168 [ Time Frame: Baseline, 168 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline of Volumetric Magnetic Resonance Imaging (vMRI) to Week 168 [ Time Frame: Baseline, Week 168 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1150
Study Start Date: February 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: solanezumab
400 mg solanezumab intravenously (IV) every 4 weeks for 168 weeks
Drug: Solanezumab
Administered IV
Other Name: LY2062430
Placebo Comparator: Placebo
Placebo IV every 4 weeks for 168 weeks
Drug: Placebo
Administered IV

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.

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen posttreatment
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02008357

Contacts
Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact    205-934-6223      
Principal Investigator: David Geldmacher         
United States, Arizona
Banner Health Research Institute Recruiting
Phoenix, Arizona, United States, 85006
Contact    602-839-6939      
Principal Investigator: Anna Burke         
Banner Sun Health Research Institute Recruiting
Sun City, Arizona, United States, 85351
Contact    623-832-6526      
Principal Investigator: Marwan Sabbagh         
United States, California
Institute for Memory Impairment & Neurological Disorders Recruiting
Irvine, California, United States, 92697
Contact    949-824-3250      
Principal Investigator: Aimee Pierce         
University of California, Irvine Recruiting
Irvine, California, United States, 92697
Contact    949-824-8726      
Principal Investigator: Ruth Mulnard         
University of California - San Diego Recruiting
La Jolla, California, United States, 92037
Contact    858-246-1245      
Principal Investigator: Doug Galasko         
University of California - Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact    310-794-6191      
Principal Investigator: Joshua Grill         
University of Southern California School of Medicine Recruiting
Los Angeles, California, United States, 90033
Contact    323-442-7594      
Principal Investigator: Lon Schneider         
University of California, Davis - Health Systems Recruiting
Martinez, California, United States, 94553
Contact    925-372-2485      
Principal Investigator: John Olichney         
Univ of California Irvine College of Medicine Recruiting
Orange, California, United States, 92868
Contact    714-456-5697      
Principal Investigator: Steve Potkin         
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact    650-852-3287      
Principal Investigator: Jerome Yesavage         
Univ of California San Francisco Recruiting
San Francisco, California, United States, 94158
Contact    415-476-0671      
Principal Investigator: Adam Boxer         
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Contact    203-764-8100      
Principal Investigator: Chris Van Dyck         
United States, District of Columbia
Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20057
Contact    202-687-8800      
Principal Investigator: Raymond Turner         
Howard University Hospital Recruiting
Washington, District of Columbia, United States, 20060
Contact    202-865-3776      
Principal Investigator: Thomas Obisesan         
United States, Florida
Mayo Clinic of Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact    904-953-9680      
Principal Investigator: Neil Graff-Radford         
Wien Center for Clinical Research Recruiting
Miami Beach, Florida, United States, 33140
Contact    305-674-2121 ext 54480      
Principal Investigator: Ranjan Duara         
University of South Florida Recruiting
Tampa, Florida, United States, 33613
Contact    813-974-4355      
Principal Investigator: Amanda Smith         
Premiere Research Institute at Palm Beach Neurology Not yet recruiting
West Palm Beach, Florida, United States, 33407
Contact    561-845-0500 ext 124      
Principal Investigator: Carl Sadowsky         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact    404-728-6395      
Principal Investigator: James Lah         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact    312-503-2486      
Principal Investigator: Sandra Weintraub         
Rush Alzheimer's Disease Center Recruiting
Chicago, Illinois, United States, 60612
Contact    312-563-4111      
Principal Investigator: Neelum Aggarwal         
United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
Contact    317-963-7429      
Principal Investigator: Martin Farlow         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact    319-353-5158      
Principal Investigator: Susan Shultz         
United States, Kansas
University of Kansas Hospital Recruiting
Fairway, Kansas, United States, 66205
Contact    913-945-5033      
Principal Investigator: Jeffrey Burns         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40504
Contact    859-323-3145      
Principal Investigator: Gregory Jicha         
United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21093
Contact    410-550-9054      
Principal Investigator: Paul Rosenburg         
United States, Massachusetts
Brigham and Womens Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact    617-278-0376      
Principal Investigator: Gad Marshall         
Boston University Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact    617-638-5670      
Principal Investigator: Robert Stern         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48105
Contact    734-647-7760      
Principal Investigator: Judith Heidebrink         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact    507-284-1324      
Principal Investigator: David Knopman         
United States, Missouri
Washington University School of Medicine Not yet recruiting
St. Louis, Missouri, United States, 63110
Contact    314-286-2363      
Principal Investigator: Randall Bateman         
United States, Nebraska
Univ of Nebraska Med Center Recruiting
Omaha, Nebraska, United States, 68198
Contact    402-559-4496      
Principal Investigator: Daniel Murman         
United States, Nevada
Cleveland Clinic of Las Vegas Recruiting
Las Vegas, Nevada, United States, 89106
Contact    702-483-6026      
Principal Investigator: Charles Bernick         
United States, New York
Dent Neurological Institute Recruiting
Amherst, New York, United States, 14226
Contact    716-819-4117      
Principal Investigator: Horacio Capote         
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact    212-659-8883      
Principal Investigator: M Sano         
New York University Medical Center Recruiting
New York, New York, United States, 10016
Contact    212-263-0771      
Principal Investigator: Melanie Shulman         
Weill Cornell Medical College Not yet recruiting
New York, New York, United States, 10021
Contact    212-746-6580      
Principal Investigator: Norman Relkin         
Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
Contact    212-305-7661      
Principal Investigator: Karen Bell         
Nathan Kline Psychiatric Research Institute Recruiting
Orangeburg, New York, United States, 10962
Contact    845-398-5582      
Principal Investigator: Nunzio Pomara         
University of Rochester Recruiting
Rochester, New York, United States, 14620
Contact    585-760-6562      
Principal Investigator: Anton Porsteinsson         
United States, North Carolina
Wake Forest University School of Medicine Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact    336-713-6463 ext 7      
Principal Investigator: Suzanne Craft         
United States, Ohio
Case Western Reserve University Recruiting
Beachwood, Ohio, United States, 44122
Contact    216-464-6454      
Principal Investigator: Alan Lerner         
United States, Oklahoma
Tulsa Clinical Research LLC Recruiting
Tulsa, Oklahoma, United States, 74104
Contact    918-743-2349      
Principal Investigator: Ralph Richter         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact    503-494-7615      
Principal Investigator: Deniz Erten-Lyons         
United States, Pennsylvania
Drexel University College of Medicine at EPPI Not yet recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact    215-762-1776      
Principal Investigator: Carol Lippa         
University of Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact    215-662-4379      
Principal Investigator: Steve Arnold         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact    412-692-2730      
Principal Investigator: Oscar Lopez         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact    401-444-2484      
Principal Investigator: Brian Ott         
Butler Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact    401-455-6403      
Principal Investigator: Stephen Salloway         
United States, South Carolina
Roper Hospital Recruiting
Charleston, South Carolina, United States, 29401
Contact    843-740-1592 ext 38      
Principal Investigator: Jacobo Mintzer         
United States, Texas
University of Texas Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390
Contact    214-648-9343      
Principal Investigator: Mary Quiceno         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact    713-798-5385      
Principal Investigator: Rachelle Doody         
United States, Washington
University of Washington School of Medicine Recruiting
Seattle, Washington, United States, 98108
Contact    206-764-2339      
Principal Investigator: Elaine Peskind         
United States, Wisconsin
University of Wisconsin-Madison Hospital and Health Clinic Recruiting
Madison, Wisconsin, United States, 53705
Contact    608-256-1901 ext 1640      
Principal Investigator: Cynthia Carlsson         
Australia, Victoria
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. Not yet recruiting
Parkville, Victoria, Australia, 3010
Contact: Eli Lilly and Company         
Canada, British Columbia
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. Not yet recruiting
Vancouver, British Columbia, Canada, V6T 2B5
Contact: Eli Lilly and Company         
Canada, Ontario
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. Recruiting
London, Ontario, Canada, N6C 5J1
Contact: Eli Lilly and Company         
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. Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Eli Lilly and Company         
Sponsors and Collaborators
Eli Lilly and Company
Alzheimer's Disease Cooperative Study (ADCS)
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02008357     History of Changes
Other Study ID Numbers: 15275, H8A-MC-LZAZ, ADC-040-A4
Study First Received: December 6, 2013
Last Updated: October 2, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Eli Lilly and Company:
Cognition
Prevention

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 23, 2014