CompletedPhase 3

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

United States, Australia, Canada1,169 participantsStarted 2014-02-28

Plain-language 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 \[AD\]).

Who can participate

Age range

65 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 ap…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this was a Phase 3 trial testing solanezumab in people who may be at risk for memory loss but don't yet have symptoms, what did the results show about whether the drug actually slowed cognitive decline on the PACC score, and does that affect whether my doctor thinks it's a promising direction?
2Because this trial has already completed, is the data published and what did it show about the safety profile of solanezumab in older adults — were there any side effects I should know about before considering anything in this class of drugs?
3The trial focused on people who 'may be at risk' for memory loss — what does my doctor think it would take to determine whether I fall into a similar risk category, and would any tests like amyloid imaging have been relevant for my situation?
4Given that solanezumab itself has had a complicated history in Alzheimer's research, how does my doctor weigh the findings from this completed trial against other emerging treatments or standard monitoring approaches for someone in my position?
5Since this trial is now completed and no longer enrolling, are there similar or follow-on studies currently open that my doctor thinks might be worth exploring based on what was learned here?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline of the Preclinical Alzheimer Cognitive Composite (PACC) Score

Timeframe: Baseline, Week approximately 240

Change From Baseline of the Preclinical Alzheimer Cognitive Composite (PACC) Score

Timeframe: Baseline, Week 336

Trial details

NCT IDNCT02008357

SponsorEli Lilly and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-27

Results submitted2023-12-14

View on ClinicalTrials.gov More Cognition Disorders trials

Who can participate

Age range

65 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.