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 22, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cognition Disorders | Drug: Solanezumab Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1150 participants |
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) |
Actual Study Start Date : | February 2014 |
Estimated Primary Completion Date : | July 2022 |
Estimated Study Completion Date : | July 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Solanezumab
Solanezumab (400-1600 milligrams) intravenously (IV) every 4 weeks for 240 weeks.
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Drug: Solanezumab
Administered IV
Other Name: LY2062430
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Placebo Comparator: Placebo
Placebo IV every 4 weeks for 240 weeks.
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Drug: Placebo
Administered IV
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- Change from Baseline of the ADCS Preclinical Alzheimer Cognitive Composite (ADCS-PACC) to Week 240 [ Time Frame: Baseline, Week 240 ]
- 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 ]

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Ages Eligible for Study: | 65 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02008357

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 |
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 ) |
First Posted: | December 11, 2013 Key Record Dates |
Last Update Posted: | December 22, 2017 |
Last Verified: | December 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 |