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Could a drug stop Alzheimer's before symptoms start?

NCT ID NCT02008357

Prevention Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This trial tests whether solanezumab, an antibody that targets amyloid plaques in the brain, can slow the progression of memory problems in people who have no symptoms but show early signs of Alzheimer's-related brain changes. Participants are older adults with normal thinking and memory but with a PET scan showing amyloid buildup. The study compares solanezumab to a placebo to see if the drug can preserve cognitive function over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
solanezumab (an investigational antibody that targets amyloid plaques in the brain)
What this could lead to
If successful, this could lead to a treatment that delays or prevents memory loss in people at risk for Alzheimer's disease.
What could go wrong
This is an early-stage test in people without symptoms, and it may not slow memory decline. The drug also carries risks like brain swelling or bleeding, which the trial monitors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,169 people

The number who actually took part.

Started

Feb 2014

Finished

Jun 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognition Disorders cognitive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cognition disorders

Contacts and locations

Locations

  • Banner Health Research Institute

    Phoenix, Arizona, 85006, United States

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351, United States

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Boston University Medical Center

    Boston, Massachusetts, 02118, United States

  • Brain Matters Research

    Delray Beach, Florida, 33445, United States

  • Brigham and Womens Hospital

    Boston, Massachusetts, 02115, United States

  • Butler Hospital

    Providence, Rhode Island, 02906, United States

  • Case Western Reserve University

    Beachwood, Ohio, 44122, United States

  • Cleveland Clinic of Las Vegas

    Las Vegas, Nevada, 89106, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Compass Research - Orlando

    Orlando, Florida, 32806, United States

  • Compass Research -The Villages

    The Villages, Florida, 32162, United States

  • Dent Neurological Institute

    Amherst, New York, 14226, United States

  • Drexel University College of Medicine at EPPI

    Philadelphia, Pennsylvania, 19102, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Parkville, Victoria, 3010, Australia

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Bunkyō City, 113-8655, Japan

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    London, N6C 0A7, Canada

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    Toronto, M3B2S7, Canada

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    Vancouver, V6T 2B5, Canada

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20057, United States

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640, United States

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Howard University Hospital

    Washington D.C., District of Columbia, 20060, United States

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

  • Institute for Memory Impairment & Neurological Disorders

    Irvine, California, 92697, United States

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21093, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic-Jacksonville

    Jacksonville, Florida, 32224, United States

  • Mount Sinai School of Medicine

    New York, New York, 10029, United States

  • New York University Medical Center

    New York, New York, 10016, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808-4124, United States

  • Premiere Research Institute at Palm Beach Neurology

    West Palm Beach, Florida, 33407, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02906, United States

  • Roper Hospital

    Charleston, South Carolina, 29401, United States

  • Rush Alzheimer's Disease Center

    Chicago, Illinois, 60612, United States

  • Sunnybrook Health Sciences Centre

    Toronto, M4N 3M5, Canada

  • Sutter Medical Group

    Sacramento, California, 95816, United States

  • Syrentis Clinical Research

    Santa Ana, California, 92705, United States

  • Tulsa Clinical Research LLC

    Tulsa, Oklahoma, 74104, United States

  • Univ of California Irvine College of Medicine

    Orange, California, 92868, United States

  • Univ of California San Francisco

    San Francisco, California, 94158, United States

  • Univ of Nebraska Med Center

    Omaha, Nebraska, 68198, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of California - Los Angeles

    Los Angeles, California, 90095, United States

  • University of California - San Diego

    La Jolla, California, 92037, United States

  • University of California, Davis - Health Systems

    Walnut Creek, California, 94598, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Kansas Hospital

    Fairway, Kansas, 66205, United States

  • University of Kentucky

    Lexington, Kentucky, 40504, United States

  • University of Michigan

    Ann Arbor, Michigan, 48105, United States

  • University of Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Rochester

    Rochester, New York, 14620, United States

  • University of South Florida

    Tampa, Florida, 33613, United States

  • University of Southern California School of Medicine

    Los Angeles, California, 90033, United States

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75235, United States

  • University of Washington School of Medicine

    Seattle, Washington, 98108, United States

  • University of Wisconsin-Madison Hospital and Health Clinic

    Madison, Wisconsin, 53705, United States

  • Veterans Affairs Medical Center Palo Alto

    Palo Alto, California, 94304, United States

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medical College

    New York, New York, 10021, United States

  • Wien Center for Clinical Research

    Miami Beach, Florida, 33140, United States

  • Yale University School of Medicine

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.