Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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 September 2016 by Eli Lilly and Company
Sponsor:
Collaborator:
Alzheimer's Therapeutic Research Institute
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02008357
First received: December 6, 2013
Last updated: September 21, 2016
Last verified: September 2016
History of Changes
  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:

U.S. FDA Resources

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: October 2020
Estimated Primary Completion Date: October 2020 (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   (Adult, Senior)
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

  Show 68 Study Locations
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
  More Information

Additional Information:
Click here for more information about this study: A Study of Solanezumab in Older Participants Who May be at Risk for Memory Loss (A4)  This link exits the ClinicalTrials.gov site

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02008357     History of Changes
Other Study ID Numbers: 15275  H8A-MC-LZAZ 
Study First Received: December 6, 2013
Last Updated: September 21, 2016
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
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2016