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

Completed · Phase 3 · Has a placebo group

Conditions studied: Cognition Disorders

In brief

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 \[AD\]).

Key facts

Study ID

NCT02008357

Run by

Eli Lilly and Company

People needed

1169

Starts

2014-02-28

Expected to finish

2023-06-08

Last updated by the study team

2026-08-03

Who can join

Age: 65 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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
• Open-Label Inclusion Criteria:
• All participants who complete the placebo-controlled period will be allowed to continue into the open-label period

Where it is running

• University of California - Los Angeles — Los Angeles, California, United States
• Univ of California Irvine College of Medicine — Orange, California, United States
• Veterans Affairs Medical Center Palo Alto — Palo Alto, California, United States
• Sutter Medical Group — Sacramento, California, United States
• Univ of California San Francisco — San Francisco, California, United States
• Syrentis Clinical Research — Santa Ana, California, United States
• University of California, Davis - Health Systems — Walnut Creek, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Howard University Hospital — Washington D.C., District of Columbia, United States
• Brain Matters Research — Delray Beach, Florida, United States
• Mayo Clinic-Jacksonville — Jacksonville, Florida, United States
• Wien Center for Clinical Research — Miami Beach, Florida, United States
• Compass Research - Orlando — Orlando, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Compass Research -The Villages — The Villages, Florida, United States
• Premiere Research Institute at Palm Beach Neurology — West Palm Beach, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Rush Alzheimer's Disease Center — Chicago, Illinois, United States
• Great Lakes Clinical Trials — Chicago, Illinois, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kansas Hospital — Fairway, Kansas, United States
• University of Southern California School of Medicine — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.