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

Study Description

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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]).

Condition or disease	Intervention/treatment	Phase
Cognition Disorders	Drug: Solanezumab; Drug: Placebo	Phase 3

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 Design

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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

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Change from Baseline of the ADCS Preclinical Alzheimer Cognitive Composite (ADCS-PACC) to Week 240 [ Time Frame: Baseline, Week 240 ]

Secondary Outcome Measures :

1. Change from Baseline in Cognitive Function Index (CFI) to Week 240 [ Time Frame: Baseline, Week 240 ]
2. 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 ]
3. Change from Baseline in Mean Composite Standardized Uptake Value Ratio (SUVr) to Week 240 [ Time Frame: Baseline, Week 240 ]
4. Change from Baseline in Cerebrospinal Fluid (CSF) Tau Biomarkers to Week 240 [ Time Frame: Baseline, 240 Weeks ]
5. Change from Baseline of CSF Concentrations of Amyloid Beta (Abeta) to Week 240 [ Time Frame: Baseline, 240 Weeks ]
6. Change from Baseline of Volumetric Magnetic Resonance Imaging (vMRI) to Week 240 [ Time Frame: Baseline, Week 240 ]

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  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

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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) 

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
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