This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease (NCT02760602), a randomized phase 3 study. The primary outcome is Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02760602 |
| Phase | Phase 3 |
| Condition | Alzheimer's Disease |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 26 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Participants with prodromal Alzheimer’s disease were the intended population. The registry lists Alzheimer’s disease as the condition but does not report detailed eligibility criteria, diagnostic thresholds, or other characteristics of the enrolled participants. Enrollment was 26.
Intervention
Solanezumab was given intravenously once every 4 weeks for up to 2 years. The registry describes the study’s purpose as investigating the drug’s safety and efficacy in participants with prodromal Alzheimer’s disease.
Comparator
The comparison group received placebo intravenously once every 4 weeks for up to 2 years. The study is described as placebo-controlled, randomized, triple-masked, and parallel-group.
Primary question
The primary outcome was change from baseline in the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog14) score, assessed from baseline to 24 months. The registry reports that zero participants were analyzed because no data were collected. Therefore, the primary question cannot be answered from the posted results.
In statistical terms, the intended comparison concerns whether the outcome’s change over time differed between the solanezumab and placebo groups. The registry record does not provide a numerical estimate of that difference, its uncertainty, or a statistical test. It also does not report an analyzed population for the primary outcome. The stated study objective and design describe what the trial set out to investigate; they are not evidence of an observed effect. The clinical question is consequently clear, but the registry’s primary outcome information does not allow an estimate of how the groups compared.
3. Trial Design
This was a randomized, triple-masked, parallel-group Phase 3 study with a placebo comparator. Its official title describes a multicenter study lasting 24 months and comparing the efficacy and safety of solanezumab with placebo in prodromal Alzheimer’s disease. Enrollment was 26. The registry lists the study status as terminated, with a start date of 2016-06 and primary completion of 2017-05.
Participants assigned to the solanezumab group were to receive intravenous solanezumab once every 4 weeks for up to 2 years. Participants assigned to the placebo group were to receive intravenous placebo at the same frequency and for the same maximum duration. The parallel-group design means the treatment groups were followed as separate groups rather than participants crossing from one assigned treatment to the other, according to the design description.
Randomization is intended to reduce systematic differences between groups at assignment, while masking is intended to limit influences on care, assessment, or reporting. Those are general purposes of these design features, not evidence that bias was absent in this trial. The registry does not report the random sequence method, allocation concealment, which parties were masked, or whether masking was maintained.
The record does not report why the study was terminated, whether all enrolled participants received study treatment, how long participants were followed, or whether the planned enrollment was reached. It also does not report the protocol’s sample-size justification or a detailed analysis plan. The registered treatment duration and trial design therefore describe the intended comparison, but the primary outcome record indicates that no participants were analyzed because no data were collected.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Participants were randomized by site and by use of florbetapir positron emission tomography (PET) scanning or cerebrospinal fluid (CSF) for study eligibility.
Overall Study
| Stage | Solanezumab | Placebo |
|---|---|---|
| STARTED | 13 | 13 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 13 | 13 |
Reasons for not completing this period:
| Reason | Solanezumab | Placebo |
|---|---|---|
| Withdrawal by Subject | 1 | 0 |
| Terminated by sponsor | 12 | 13 |
Analysis population for the primary outcome, as defined in the registry: Zero participants were analyzed as no data collected.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: All enrolled participants who received at least one dose of study drug.
| Characteristic | Unit | Solanezumab | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 13 | 13 | 26 | |
| Age, Continuous | years | 73.46 (SD 6.01) | 75.62 (SD 4.93) | 74.54 (SD 5.49) |
| Sex: Female, Male: Female | Participants | 4 | 6 | 10 |
| Sex: Female, Male: Male | Participants | 9 | 7 | 16 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 12 | 13 | 25 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 3 | 0 | 3 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): White | Participants | 9 | 12 | 21 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 10 | 11 | 21 |
| Region of Enrollment: Japan | Participants | 2 | 0 | 2 |
| Region of Enrollment: Canada | Participants | 1 | 0 | 1 |
| Region of Enrollment: Poland | Participants | 0 | 2 | 2 |
| ADAS-Cog14 at Baseline | units on a scale | 24.08 (SD 8.00) | 27.77 (SD 3.63) | 25.92 (SD 6.37) |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score, measured over Baseline, 24 Months.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was change from baseline in the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog14) score, with baseline and 24 months listed as the assessment time points. The registry describes ADAS-Cog14 as ADAS-Cog11 augmented with orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze-completion measures. Its range is 0 to 90, and higher scores indicate greater disease severity.
A change-from-baseline endpoint expresses how a participant’s score at follow-up differs from that participant’s starting score. Comparing changes between randomized groups can describe whether their score trajectories differed over the specified period. This is a general explanation of the endpoint; the registry record does not report the actual change scores, a group comparison, or a statistical model used to analyze them.
Cognitive scales are used in research to quantify performance on specified assessments. For this endpoint, the scale direction matters: a higher score corresponds to greater disease severity. The registry does not report an interpretation threshold for a clinically meaningful change, nor does it provide a result that could be assessed against such a threshold.
The primary outcome entry states that zero participants were analyzed because no data were collected. Thus, although the endpoint and its measurement range are described, there is no posted estimate of change for either group and no estimate of the difference between groups.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive fact is that the registry reports zero participants analyzed for the primary outcome because no data were collected. This is not a null finding, and it is not evidence that the treatment groups had the same outcome. A null finding would ordinarily require outcome data and an analysis whose estimate and uncertainty could be evaluated. No such primary endpoint estimate is reported.
The study enrolled 26 participants, and the safety record lists 13 participants at risk in each group for serious adverse events and for other adverse events. Those safety counts do not supply missing cognitive outcome data. The primary efficacy endpoint was change from baseline in ADAS-Cog14 from baseline to 24 months, but the registry does not report analyzed scores at either time point or a comparison of changes.
The record lists 17 outcome measures and zero analyses. It does not provide a primary-outcome effect estimate, confidence interval, p-value, or other inferential result. Without an estimate and its uncertainty, readers cannot assess the direction, size, or precision of a between-group difference. A statistical test cannot establish an effect in the absence of reported analyzed outcome data.
The study’s randomized, triple-masked, placebo-controlled design describes how the comparison was intended to be organized. Randomization can support a fair comparison when outcomes are collected and analyzed appropriately, but the design alone does not establish the result. Likewise, the Phase 3 label and the stated purpose of investigating safety and efficacy are descriptions of the trial, not findings.
Termination is recorded, but the reason is not reported in the registry record. It would be inappropriate to infer why the study ended or whether the termination itself reflects an outcome. The record also does not explain whether participants discontinued, whether assessments were missed, or whether any data were collected but not submitted. The stated reason for zero analyzed participants is that no data were collected.
Consequently, the posted primary outcome information leaves the clinical comparison unresolved. The data do not show a benefit, lack of benefit, or equivalence for the primary endpoint. Equivalence would require an appropriate analysis and a sufficiently precise interval judged against a prespecified margin; neither is reported. The same caution applies to any attempt to infer treatment effects from the safety counts: those counts are descriptive and do not replace a primary efficacy analysis.
9. Statistical Methods Explained
What does randomization contribute?
General statistical explanation: Randomization assigns participants by chance to study groups. Its purpose is to make treatment assignment independent of measured and unmeasured participant characteristics on average, which can make group comparisons more interpretable. It does not guarantee that the groups will be identical, especially in a small study, and it cannot compensate for missing outcomes. This record identifies the study as randomized but does not report how the sequence was generated or how assignment was concealed.
What does masking mean?
General statistical explanation: Masking is intended to reduce the influence of treatment knowledge on participant experience, clinical care, outcome assessment, or analysis. The record describes the study as triple-masked, but does not specify which groups of people were masked or whether masking was maintained. The label alone cannot establish that expectations or assessment decisions had no influence.
How should a change-from-baseline endpoint be understood?
General statistical explanation: A change score compares a follow-up measurement with a baseline measurement for the same participant. A group comparison can then summarize whether average changes differed between assigned groups. Other valid approaches may model follow-up scores while accounting for baseline values. The analysis method selected can affect the estimate and its precision; the registry does not report the method used for ADAS-Cog14. In this study, the specified follow-up was 24 months, but the registry reports no participants analyzed because no data were collected.
What do estimates and confidence intervals tell readers?
General statistical explanation: An effect estimate describes the magnitude and direction of a contrast, while a confidence interval describes the uncertainty around that estimate under the assumptions of the analysis. A narrow interval generally conveys greater precision than a wide one. A p-value, when reported, addresses compatibility of the observed data with a specified statistical model and null hypothesis; it does not measure clinical importance. None of these inferential quantities is reported for the primary endpoint, so its effect and precision cannot be evaluated.
What is the role of the planning illustrations?
The registry record describes planning illustrations based on an observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation; the effect to detect is expressed as a stated fraction of the observed effect. These are planning assumptions, not a report of the trial’s original design justification and not observed power. The registry does not report the protocol’s sample-size justification. Because the primary outcome entry reports no analyzed participants and no collected data, planning assumptions cannot be used as evidence of a treatment effect or as a substitute for an observed estimate.
Why do analysis choices matter?
General statistical explanation: A statistical model should reflect the outcome type, study design, and data structure. Repeated measurements may require a method that accounts for measurements from the same participant; a single change score is a different way to summarize follow-up. Adjustments for baseline characteristics, handling of departures from treatment assignment, and assumptions about missing values can also affect the result. The registry does not report which methods were planned or used, so it is not possible to determine how such choices were addressed.
For any analysis, assumptions matter. If a model’s assumptions do not fit the observed data, estimates or uncertainty measures may be misleading. General statistical practice includes checking whether model assumptions are reasonable and considering alternative analyses when appropriate. The registry does not report such checks or sensitivity analyses. In this record, however, the primary issue comes before model choice: the endpoint entry states that no data were collected and no participants were analyzed.
The study also listed several cognitive, functional, and neuropsychiatric secondary outcomes. When many outcomes or comparisons are evaluated, the chance of at least one apparently unusual result can increase; this is the general reason multiplicity matters. Statistical plans may address this through a prespecified hierarchy, adjustment, or a careful distinction between confirmatory and exploratory analyses. The registry does not report a multiplicity strategy, and it lists zero analyses. Therefore, no secondary finding can be interpreted as a reported statistical result.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 17 outcome measures and zero analyses. The primary endpoint is change from baseline in ADAS-Cog14 at 24 months, but zero participants were analyzed because no data were collected. The record does not provide a primary outcome estimate or inferential test. It also does not report analyses for the listed secondary outcomes, which include measures of daily activities, cognition, function, neuropsychiatric symptoms, and memory.
Multiplicity is a general statistical concern when a study examines multiple outcomes, time points, or contrasts. Conducting many tests can increase the chance of finding an apparently notable result by chance. A protocol may limit that concern by defining a primary outcome, specifying an order for testing, or adjusting the analysis. The registry does not report whether any such strategy was planned. The registered primary endpoint identifies the main outcome, but that alone does not reveal how secondary outcomes or other comparisons were to be handled.
The registry does not report the missing-data approach, analysis population definitions, or whether any sensitivity analyses were planned. It states that no data were collected for the primary outcome, which is distinct from reporting that some outcome values were missing among analyzed participants. The record does not explain the circumstances behind this statement or describe any data collection for other outcomes. Without outcome data and analysis details, readers cannot assess how missing observations, deviations from assigned treatment, or participant withdrawals were handled.
These omissions limit appraisal of both the planned statistical approach and the results. They do not justify assuming a particular method or reason for missing data.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Solanezumab | 2 | 13 | 15.4% |
| Placebo | 1 | 13 | 7.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Solanezumab | 0 of 13 |
| Placebo | 0 of 13 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Solanezumab | 7 of 13 |
| Placebo | 1 of 13 |
Most frequent serious adverse event terms
| Event term | Organ system | Solanezumab | Placebo |
|---|---|---|---|
| Coronary artery disease | Cardiac disorders | 1 of 13 | 0 of 13 |
| Pneumonia | Infections and infestations | 0 of 13 | 1 of 13 |
| Syncope | Nervous system disorders | 1 of 13 | 0 of 13 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Solanezumab | Placebo |
|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | 2 of 13 | 1 of 13 |
| Coronary artery disease | Cardiac disorders | 1 of 13 | 0 of 13 |
| Constipation | Gastrointestinal disorders | 1 of 13 | 0 of 13 |
| Extravasation | General disorders | 1 of 13 | 0 of 13 |
| Viral upper respiratory tract infection | Infections and infestations | 1 of 13 | 0 of 13 |
| Fall | Injury, poisoning and procedural complications | 1 of 13 | 0 of 13 |
| Skin abrasion | Injury, poisoning and procedural complications | 1 of 13 | 0 of 13 |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | 1 of 13 | 0 of 13 |
| Insomnia | Psychiatric disorders | 1 of 13 | 0 of 13 |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | 1 of 13 | 0 of 13 |
Serious events with the highest arm-level rate: coronary artery disease (7.7%), pneumonia (7.7%), syncope (7.7%).
The registry reports serious adverse events for 2 of 13 participants at risk in the solanezumab group and 1 of 13 participants at risk in the placebo group. It reports other adverse events for 7 of 13 participants at risk in the solanezumab group and 1 of 13 participants at risk in the placebo group. Deaths are listed as 0 in both groups.
These are descriptive counts from the registry record. They do not, by themselves, establish that treatment caused an event or that an observed difference between groups is statistically reliable. The record does not provide a statistical comparison, confidence interval, event timing, exposure-adjusted analysis, or details about whether individual participants experienced more than one event. Counts of participants affected should not be interpreted as counts of all event episodes unless the record says so.
The registry lists coronary artery disease, pneumonia, and syncope among the top serious adverse event terms, each with a reported value of 7.7%. The record does not provide enough context to determine whether these terms occurred in different participants or whether categories overlapped. The percentages should therefore be read as the registry’s reported descriptions, not combined or independently recalculated.
Safety results are separate from the primary cognitive endpoint. They do not fill the gap in the primary efficacy record, and the listed counts alone do not establish a treatment-related safety conclusion.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, triple-masked, placebo-controlled Phase 3 study was registered to investigate solanezumab in prodromal Alzheimer’s disease. It specifies the intended treatment comparison, the primary cognitive endpoint, and several secondary outcomes. It also records enrollment of 26 and a terminated status.
What it does not establish is the primary outcome result. The registry states that zero participants were analyzed because no data were collected. There is no reported ADAS-Cog14 change for either group, no between-group estimate, and no measure of uncertainty. This means the posted primary outcome cannot show whether the groups differed, how large any difference might have been, or how precise an estimate would be.
The absence of an analyzed outcome is not evidence that solanezumab and placebo had the same effect. It is also not evidence of benefit or harm on the cognitive endpoint. A conclusion about no difference would require analyzable data and an appropriate comparison; a conclusion about equivalence would require additional prespecified criteria and sufficiently precise results. None of those results is reported.
The safety entries provide counts of participants affected and list several serious event terms, but they do not establish causation or a comparative safety effect. They should be interpreted as registry-reported descriptive information. The record does not explain why the trial was terminated, and its status should not be treated as an explanation of the outcome data.
Overall, the design and intended question are documented, but the posted results do not answer the primary efficacy question. The registry record supports describing the study’s structure and the reported safety counts; it does not support a conclusion about the treatment’s effect on ADAS-Cog14.
13. Why This Trial Matters Statistically
This trial is statistically notable because the registry gives a clear primary endpoint and randomized comparison but reports no analyzed primary outcome data. That distinction is important: a trial design can define a question rigorously without producing a result that answers it. Readers need outcome estimates and their uncertainty, not only the treatment objective or design description, to assess the comparative evidence.
The study is described as Phase 3, randomized, triple-masked, parallel-group, and placebo-controlled. Those design features are intended to support a fair comparison and reduce bias. They do not replace collected outcome data. With zero participants analyzed for the primary endpoint, there is no reported effect size, confidence interval, or statistical test to interpret.
The record also illustrates why a registry’s outcome and analysis reporting matter. It lists 17 outcome measures but zero analyses, and it does not report the analysis plan, missing-data methods, or multiplicity strategy. These omissions prevent readers from evaluating how secondary outcomes were handled or what inferential framework would have been used. The termination reason is not reported in the registry record, so the study’s status cannot be used to infer a statistical or clinical explanation.
Planning assumptions are not a substitute for trial results. The registry describes illustrations based on an observed effect and specified statistical assumptions, but those assumptions do not establish an observed treatment effect or the original design rationale. More broadly, planning calculations address what a study might detect under stated conditions; they do not establish what the collected data show.
The main statistical lesson is therefore about the boundary between a registered research question and an interpretable result. Here, the question and intended design are documented, while the primary endpoint result is unavailable in the registry record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most consequential limitation for interpretation is the registry statement that zero participants were analyzed for the primary endpoint because no data were collected. Without analyzed ADAS-Cog14 values, there is no primary comparison to evaluate. No estimate, confidence interval, or p-value is reported for the endpoint.
The registry records enrollment of 26 and terminated status but does not report why the study was terminated or how many participants completed follow-up. It does not describe participant characteristics, detailed eligibility criteria, adherence, treatment exposure, or the timing and extent of follow-up. These details would help readers understand the enrolled population and the conduct of the study, but are not reported in the registry record.
The record does not report the statistical analysis plan, analysis populations, randomization procedure, allocation concealment, or the identities of the parties included in triple masking. It also does not report how missing data, protocol deviations, or multiple outcomes were to be handled. These gaps limit appraisal of the planned analysis independently of the absence of outcome data.
The safety information is limited to reported counts and selected serious event terms. The registry does not provide event-level detail, timing, exposure-adjusted results, or a statistical comparison. The listed counts should not be treated as proof of causation or as a complete comparative safety analysis.
Finally, the primary endpoint is described, including its score range and direction, but no threshold for a clinically meaningful change is reported. Even if a numerical difference were available, the record would not provide that contextual benchmark. Taken together, these limitations mean the registry supports a description of the intended study and its reported safety counts, but not a conclusion about the primary treatment effect.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease — NCT02760602.
- Registry record last updated 2019-10-10; status last verified 2019-09.
- Results first posted 2018-07-24.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT02760602 is a randomized, triple-masked, parallel-group Phase 3 study of solanezumab versus placebo in participants with prodromal Alzheimer’s disease. The official title describes a multicenter, 24-month study. Both treatments were to be administered intravenously once every 4 weeks for up to 2 years. Enrollment was 26, and the registry lists the status as terminated.
The primary endpoint was change from baseline in ADAS-Cog14 at 24 months. The registry reports zero participants analyzed because no data were collected. It lists 17 outcome measures and zero analyses. The reason for termination, statistical analysis plan, and missing-data methods are not reported in the registry record.
For safety, the record lists serious adverse events in 2 of 13 participants at risk in the solanezumab group and 1 of 13 in the placebo group; deaths are listed as 0 in each group. These are descriptive registry counts and do not establish a comparative treatment effect. The primary efficacy question remains unanswered by the posted results.