Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT02008357) enrolled 1,169 participants across two groups during the main double-blind phase: 578 people received the study drug solanezumab, and 591 received a placebo (an inactive treatment used for comparison). The trial was measuring whether solanezumab had any effect on cognition and daily functioning in people who showed early biological signs associated with Alzheimer's disease but had not yet developed noticeable symptoms. After the main phase ended, many participants moved into an open-label extension period, where both groups received solanezumab. The reported data shows that the main outcome measured was change in a combined thinking and memory score called the PACC — a composite of four different cognitive tests, where a score of zero represents no change from the starting point and a more negative number indicates a greater decline. By the end of the double-blind period, the solanezumab group's average score had changed by −1.43, while the placebo group's average score had changed by −1.13 — meaning both groups showed a decline from their starting scores, with the solanezumab group showing a slightly larger decline. No figures were reported for the open-label extension phase outcomes. The reported data also shows results for two secondary (additional) measures. On the Cognitive Function Index — a questionnaire about everyday thinking ability scored from 0 to 14, where higher scores indicate more difficulty — the solanezumab group's score changed by +1.94 and the placebo group's by +1.47, meaning both groups reported increased difficulty over time. On a daily activities questionnaire scored from 0 to 45 (where higher scores mean fewer difficulties), the solanezumab group's score changed by −2.29 and the placebo group's by −1.70, indicating a decline in both groups. Again, no figures were reported for the open-label extension phase for these measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 42295275) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Alzheimer's Disease Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You scored between 25 and 30 on a standard memory and thinking test called the MMSE (a score in this range suggests normal or near-normal cognition)
- You scored 0 on a scale called the Clinical Dementia Rating (CDR), which means no signs of dementia were detected at the screening visit
- You scored between 6 and 18 on a specific memory test called the Logical Memory II test
- A brain scan (called a PET scan) using a special dye shows the presence of a protein called amyloid in your brain
- You have someone in your life (such as a family member or friend) who is willing to take part as an information source and who has contact with you at least once a week, either in person, by phone, or online
- If you complete the first part of the trial (the placebo-controlled period), you will be allowed to continue into the second, open-label part of the study
Who may not be able to join:
- You are currently taking prescription medications called acetylcholinesterase inhibitors or memantine (common Alzheimer's medications)
- You have poor vein access, making it difficult to give medication through a drip or to take multiple blood samples
- You have a serious or unstable health condition affecting the heart, liver, kidneys, lungs, hormones, nerves, mental health, immune system, or blood that could affect the study results (confirm with trial site)
- You have had a serious brain infection (such as meningitis or encephalitis) or a head injury causing prolonged unconsciousness within the last 5 years
- You have had a cancer diagnosis within the last 5 years, with some exceptions for certain minor skin or prostate cancers that were fully treated and are being monitored (confirm with trial site)
- You have a known history of HIV, serious allergies to multiple medications, or a history of severe allergic skin reactions to treatments (confirm with trial site)
- The trial doctor has concerns that you may be at serious risk of suicide
- You have had major depression or bipolar disorder within the past 2 years
- You have had a problem with alcohol or drug abuse or dependence within the past 5 years
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: 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
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change From Baseline of the Preclinical Alzheimer Cognitive Composite (PACC) Score; Change From Baseline of the Preclinical Alzheimer Cognitive Composite (PACC) Score
Can't join this trial?
Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.