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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 August 2017 by Eli Lilly and Company
Sponsor:
Eli Lilly and Company
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: August 14, 2017
Last verified: August 2017
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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 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
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 240 [ Time Frame: Baseline, Week 240 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 1150 |
| Actual Study Start Date: | February 2014 |
| Estimated Study Completion Date: | July 2022 |
| Estimated Primary Completion Date: | July 2022 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Solanezumab
Solanezumab (400-1600 milligrams) intravenously (IV) every 4 weeks for 240 weeks.
|
Drug: Solanezumab
Administered IV
Other Name: LY2062430
|
|
Placebo Comparator: Placebo
Placebo IV every 4 weeks for 240 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) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 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
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
Show 68 Study Locations
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:
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT02008357 History of Changes |
| Other Study ID Numbers: |
15275 H8A-MC-LZAZ ( Other Identifier: Eli Lilly and Company ) |
| Study First Received: | December 6, 2013 |
| Last Updated: | August 14, 2017 |
| 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 Neurocognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on August 23, 2017