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The Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) Study

Purpose

The A4 Study is a clinical study for older individuals (ages 65-85) who have normal thinking and memory function but who may be at risk for developing Alzheimer's disease (AD) memory loss sometime in the future. The A4 study is for people without any outward signs of Alzheimer's disease, and is designed to evaluate the effectiveness, safety and tolerability of an investigational drug for AD. The purpose of the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s study (the "A4 study" for short) is to test whether a new investigational treatment can slow the memory loss caused by Alzheimer's disease. The overall goal of the A4 study is to test whether decreasing amyloid with antibody investigational treatment can help slow the memory loss associated with amyloid buildup in some people.
 The A4 Study lasts for three years, and participants will be assigned at random to receive either the investigational drug or a placebo and will be monitored over that period. To learn more, please call (310) 794-6039 or send an email to: This email address is being protected from spambots. You need JavaScript enabled to view it. .

Sponsor: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02008357

Condition: Intervention: Phase:
Cognition Disorders Drug: Solanezumab
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Allocation: A Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blinded (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4 Study)
Length of Study: 168 Weeks; Study treatments will take place once every 4 weeks.
Eligibility
Ages Eligible for Study: 65 Years to 85 Years
Genders Eligible for Study: Both
Criteria

Inclusion Criteria:

Has an Mini-Mental State Examination (MMSE) score at screening of 27 through 30 for participants with high educational attainment (13 or more years of education) or 25 to 30 for participants with low educational attainment (12 or fewer years of education).
Has a global Clinical Dementia Rating (CDR) scale score at screening of 0.
Has a Logical Memory II score at screening of 15 to 8 for participants with high educational attainment (13 or more years of education) or 13 to 6 for participants with low educational attainment (12 or fewer years of education).
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 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.
Have changes in medications or doses of medication in past 4 weeks.

Contact: Doug Hawkins at (310) 794-6039 or This email address is being protected from spambots. You need JavaScript enabled to view it. to participate in this study or for more information.


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