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

This study is currently recruiting participants.
Verified November 2017 by Eli Lilly and Company
Sponsor:
ClinicalTrials.gov Identifier:
NCT02008357
First Posted: December 11, 2013
Last Update Posted: November 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Alzheimer's Therapeutic Research Institute
Information provided by (Responsible Party):
Eli Lilly and Company
December 6, 2013
December 11, 2013
November 24, 2017
February 2014
July 2022   (Final data collection date for primary outcome measure)
Change from Baseline of the ADCS Preclinical Alzheimer Cognitive Composite (ADCS-PACC) to Week 240 [ Time Frame: Baseline, Week 240 ]
Change from Baseline of the ADCS Preclinical Alzheimer Cognitive Composite (ADCS-PACC) to Week 168 [ Time Frame: Baseline, Week 168 ]
Complete list of historical versions of study NCT02008357 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Cognitive Function Index (CFI) to Week 240 [ Time Frame: Baseline, Week 240 ]
  • Change from Baseline in Alzheimer's Disease Cooperative Study—Activities Daily Living—Prevention Questionnaire (ADCS-ADL-Prevention Questionnaire) Score to Week 240 [ Time Frame: Baseline, Week 240 ]
  • Change from Baseline in Mean Composite Standardized Uptake Value Ratio (SUVr) to Week 240 [ Time Frame: Baseline, Week 240 ]
  • Change from Baseline in Cerebrospinal Fluid (CSF) Tau Biomarkers to Week 240 [ Time Frame: Baseline, 240 Weeks ]
  • Change from Baseline of CSF Concentrations of Amyloid Beta (Abeta) to Week 240 [ Time Frame: Baseline, 240 Weeks ]
  • Change from Baseline of Volumetric Magnetic Resonance Imaging (vMRI) to Week 240 [ Time Frame: Baseline, Week 240 ]
  • 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 ]
Not Provided
Not Provided
 
Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss
Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4 Study)
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]).
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cognition Disorders
  • Drug: Solanezumab
    Administered IV
    Other Name: LY2062430
  • Drug: Placebo
    Administered IV
  • Experimental: Solanezumab
    Solanezumab (400-1600 milligrams) intravenously (IV) every 4 weeks for 240 weeks.
    Intervention: Drug: Solanezumab
  • Placebo Comparator: Placebo
    Placebo IV every 4 weeks for 240 weeks.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1150
July 2022
July 2022   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
65 Years to 85 Years   (Adult, Senior)
No
Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559
Australia,   Canada,   Japan,   United States
 
 
NCT02008357
15275
H8A-MC-LZAZ ( Other Identifier: Eli Lilly and Company )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Eli Lilly and Company
Eli Lilly and Company
Alzheimer's Therapeutic Research Institute
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
Eli Lilly and Company
November 2017

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