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Trial record 5 of 11 for:    Solanezumab

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

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ClinicalTrials.gov Identifier: NCT02008357
Recruitment Status : Active, not recruiting
First Posted : December 11, 2013
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
Alzheimer's Therapeutic Research Institute
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE December 6, 2013
First Posted Date  ICMJE December 11, 2013
Last Update Posted Date December 4, 2018
Actual Study Start Date  ICMJE February 28, 2014
Estimated Primary Completion Date July 22, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2018)
Change from Baseline of the Preclinical Alzheimer Cognitive Composite (PACC) [ Time Frame: Baseline, Week 240; Baseline, Week 336 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 6, 2013)
Change from Baseline of the ADCS Preclinical Alzheimer Cognitive Composite (ADCS-PACC) to Week 168 [ Time Frame: Baseline, Week 168 ]
Change History Complete list of historical versions of study NCT02008357 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2018)
  • Change from Baseline in Cognitive Function Index (CFI) [ Time Frame: Baseline, Week 240; Baseline, Week 336 ]
  • Change from Baseline in Alzheimer's Disease Cooperative Study—Activities Daily Living—Prevention Questionnaire (ADCS-ADL-Prevention Questionnaire) Score [ Time Frame: Baseline, Week 240; Baseline, Week 336 ]
  • Change from Baseline in Mean Composite Standardized Uptake Value Ratio (SUVr) [ Time Frame: Baseline, Week 240 ]
  • Change from Baseline in Cerebrospinal Fluid (CSF) Tau Biomarkers [ Time Frame: Baseline, Week 240 ]
  • Change from Baseline of CSF Concentrations of Amyloid Beta (Abeta) [ Time Frame: Baseline, Week 240 ]
  • Change from Baseline of Volumetric Magnetic Resonance Imaging (vMRI) [ Time Frame: Baseline, Week 240 ]
  • Change from Baseline on the Clinical Dementia Rating—Sum of Boxes score (CDR-SB) [ Time Frame: Baseline, Week 336 ]
  • Change from Baseline on the Computerized Cognitive Composite (C3) [ Time Frame: Baseline, Week 336 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2013)
  • Change from Baseline in Cognitive Function Index (CFI) to Week 156 [ Time Frame: Baseline, Week 156 ]
  • Change from Baseline in Alzheimer's Disease Cooperative Study—Activities Daily Living—Prevention Instrument (ADCS-ADL-PI) Score to Week 156 [ Time Frame: Baseline, Week 156 ]
  • Change from Baseline in Mean Composite Summary Uptake Value Ratio (SUVr) to Week 168 [ Time Frame: Baseline, Week 168 ]
  • Change from Baseline in Cerebral Spinal Fluid (CSF) Tau Biomarkers to Week 168 [ Time Frame: Baseline, 168 Weeks ]
  • Change from Baseline of Cerebrospinal Fluid (CSF) Concentrations of Amyloid Beta (Abeta) to Week 168 [ Time Frame: Baseline, 168 Weeks ]
  • Change from Baseline of Volumetric Magnetic Resonance Imaging (vMRI) to Week 168 [ Time Frame: Baseline, Week 168 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss
Official Title  ICMJE Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4 Study)
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]).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cognition Disorders
Intervention  ICMJE
  • Drug: Placebo
    Administered IV
  • Drug: Solanezumab
    Administered IV
    Other Name: LY2062430
Study Arms  ICMJE
  • 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.

    Intervention: Drug: Solanezumab
  • Placebo Comparator: Placebo

    Placebo IV every 4 weeks for 240 weeks.

    Participants who enter the open-label extension will receive solanezumab IV.

    Interventions:
    • Drug: Placebo
    • Drug: Solanezumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 22, 2014)
1150
Original Estimated Enrollment  ICMJE
 (submitted: December 6, 2013)
1000
Estimated Study Completion Date  ICMJE July 22, 2022
Estimated Primary Completion Date July 22, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02008357
Other Study ID Numbers  ICMJE 15275
H8A-MC-LZAZ ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Alzheimer's Therapeutic Research Institute
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date December 1, 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP