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 Effect of Elderberry Juice on Cognition and Inflammation in Patients With Mild Cognitive Impairment (NCT02414607), a randomized phase 1, phase 2 study. The primary outcome is Visuospatial Problem Solving Battery (VSP).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02414607 |
| Phase | Phase 1, Phase 2 |
| Condition | Mild Cognitive Impairment |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 24 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Missouri-Columbia |
| Results posted | Yes |
2. Clinical Question
Population
People with mild cognitive impairment (MCI). The registry record describes this group as being at high risk for Alzheimer’s disease, but further eligibility criteria and participant characteristics are not reported in the registry record.
Intervention
Elderberry juice: participants were to drink 5ml diluted in 8oz of water, 3 times per day for three months.
Comparator
Placebo: participants were to drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months.
Primary question
Does assignment to elderberry juice, rather than placebo, change performance on the Visuospatial Problem Solving Battery (VSP) in people with MCI? The registry describes change in score as the outcome and gives assessment timeframes of 12 wks and 6 mos. It does not report a single comparison or outcome estimate that answers this question.
The question focuses on a timed problem-solving task intended to detect non-memory impairments in MCI. In its description, the registry specifies that lower times are better. The listed timeframes allow the primary outcome to concern change at more than one point in follow-up, but the registry does not report how those time points were combined or which comparison was intended to be primary.
The trial also lists cognitive and daily-function measures, including the Clinical Dementia Rating Scale, Mini-Mental State Examination, Hopkins Verbal Learning Test, Boston Naming Test, Rey Complex Figure Task, Anagrams, and Instrumental Activities of Daily Living Scale. These provide context for the range of outcomes considered, but their presence does not substitute for a reported primary comparison. The record does not report estimates or conclusions for these measures.
3. Trial Design
The registry record describes a randomized, quadruple-masked, parallel-group trial in Phase 1 and Phase 2. The listed enrollment is 24. That is the registry enrollment figure; it does not establish how many participants completed treatment or contributed to each outcome analysis. The record identifies the University of Missouri-Columbia as sponsor and marks the study as completed. Its recorded start is 2016-09 and its primary completion is 2019-12.
Participants were assigned to elderberry juice or placebo. The intervention descriptions specify 5ml of the assigned liquid diluted in 8oz of water, taken 3 times per day for three months. The placebo is described as colored water. The registry calls the study quadruple-masked, but the identities of the masked groups or roles are not reported in the registry record. Details of how the random sequence was generated, how assignments were concealed, and whether masking was assessed are also not reported in the registry record.
A parallel design assigns participants to a study group and compares outcomes across groups, rather than having each participant receive both interventions in sequence. In general, random assignment is intended to make the groups comparable on average, while masking can limit the influence of expectations or knowledge of assignment on treatment delivery, assessment, and reporting. These design features do not guarantee balance or eliminate bias, and their practical implementation cannot be judged from the labels alone.
The primary outcome is the Visuospatial Problem Solving Battery, with assessment timeframes recorded as 12 wks and 6 mos. The intervention period is described as three months. The registry does not explain the timing of every assessment relative to the intervention, the handling of follow-up after treatment, or whether all participants were assessed at each recorded time point. Those details matter when interpreting a repeated outcome, but are not reported in the registry record.
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.
Overall Study
| Stage | Elderberry Juice | Placebo |
|---|---|---|
| STARTED | 11 | 13 |
| COMPLETED | 9 | 11 |
| NOT COMPLETED | 2 | 2 |
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.
| Characteristic | Unit | Elderberry Juice | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 11 | 13 | 24 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 | 0 | 1 |
| Age, Categorical: >=65 years | Participants | 10 | 13 | 23 |
| Age, Continuous | years | 76.45 (SD 8.47) | 76.23 (SD 7.73) | 76.33 (SD 6.95) |
| Sex: Female, Male: Female | Participants | 8 | 6 | 14 |
| Sex: Female, Male: Male | Participants | 3 | 7 | 10 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 11 | 13 | 24 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 11 | 13 | 24 |
| 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 | 11 | 13 | 24 |
6. Primary Endpoint
The registry lists the primary outcome as Visuospatial Problem Solving Battery (VSP), measured over 12 wks, 6 mos.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Error |
| Unit | Mean Difference Score (VPS Total Score) |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the Visuospatial Problem Solving Battery (VSP), described as a problem-solving task intended to detect non-memory impairments in people with MCI. The registry says the outcome is change in score and gives the unit as “Mean Difference Score (VPS Total Score).” Its description says that the task is timed, that each item was allowed 240 seconds for solution, and that times were averaged across items. It gives a score range of 0-240 and states that lower is better.
A timed problem-solving measure can capture task performance that may not be reflected by memory tests alone. Change scores are intended to represent how a participant’s measured performance shifts from an earlier assessment to a later one. For this endpoint, the registry’s lower-is-better direction means that a lower time corresponds to better performance on the described task; interpretation still depends on knowing which change was calculated and how it was compared between groups.
The registry lists assessment timeframes of 12 wks and 6 mos, but does not report which assessment posted the primary comparison, whether the time points were analyzed separately, or how change was calculated. There is also a naming difference within the endpoint description: the title uses VSP, while the unit refers to VPS. The intended score nomenclature is not clarified in the registry record. No group estimates, uncertainty intervals, or test results for this endpoint are reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive limitation is that the registry does not report a single primary-outcome comparison. It identifies the Visuospatial Problem Solving Battery as the primary outcome but includes more than one assessment timeframe, 12 wks and 6 mos. The record indicates that the outcome has several categories or time points and is not reduced to one comparison. Consequently, there is no posted primary estimate in this record to describe in terms of direction, size, or precision.
Without group-level outcome estimates, it is not possible to say from the registry record whether measured task times changed, whether the groups differed, or how uncertain any difference may be. No confidence interval or statistical test for the primary outcome is reported. This absence should not be interpreted as evidence that the groups were identical, nor as evidence that a difference was present. It means the record does not provide the result needed to make that comparison.
In general, an estimate describes the observed difference or change, while a confidence interval describes the range of values reasonably compatible with the data and the analysis assumptions. A narrow interval would indicate greater precision than a wide interval, but neither interval width nor estimate direction can be assessed when the relevant results are not reported. A p-value, if reported, would address compatibility with a specified null model under assumptions; it would not by itself convey the size or practical importance of an effect. The registry record supplies no primary-outcome p-value to interpret.
The timing also matters. An effect at the assessment recorded as 12 wks could differ from one at 6 mos, and combining or selecting time points changes the question being answered. The record does not say whether one time point was designated in advance as primary, whether both were co-primary, or whether a repeated-measures approach was used. The endpoint description’s use of change in score does not, by itself, specify the baseline measurement, the exact change calculation, or the comparison model.
The registry lists additional cognitive and daily-function outcomes, but does not report their estimates or analysis results. They therefore cannot be used to fill the gap in the primary result. The posted record supports description of the design and planned outcome domains, not a conclusion about the observed effect of elderberry juice on the primary measure.
9. Statistical Methods Explained
The record identifies a continuous primary measure summarized as a mean, with standard error listed as its dispersion. It does not report the outcome data or the statistical test used for the primary comparison. The following concepts explain how such methods are generally read; they do not imply that a particular analysis was conducted in this trial.
What does a mean describe?
In general, a mean is the arithmetic average of observed values. For a timed task, the mean summarizes performance across the observations included in the analysis. A mean alone does not show how individual measurements are distributed, whether some values are unusually high or low, or how much participants vary from one another. The registry’s task description says lower times are better, so the direction of a mean difference would need to be interpreted with that scoring direction in mind.
The endpoint is described as change in score, but a change score depends on which measurement is used as the reference and which follow-up value is compared with it. An analysis of change from baseline is not necessarily equivalent to an analysis that adjusts follow-up scores for baseline. The registry record does not report the calculation used, the baseline definition, or the model relating measurements over time. Readers should not infer these details solely from the word “change.”
What does a standard error indicate?
In general, a standard error describes the precision of an estimated quantity, such as a mean. It reflects uncertainty in the estimate rather than the spread of individual participant measurements. A standard deviation describes variability among observations; a standard error describes uncertainty about an estimated mean under the analysis assumptions. Neither can be interpreted fully without knowing the sample contributing to the estimate, the analysis method, and the relevant data structure. The registry lists standard error as the dispersion measure but does not report a numerical standard error for the primary endpoint.
How should a group comparison be read?
In general, a comparison should be read by considering the effect estimate, its direction, its magnitude, and its uncertainty together. For this outcome, the scoring direction matters because lower times are described as better. An estimate without an uncertainty interval can be difficult to assess for precision; an interval without a clearly identified estimand can be difficult to interpret. The registry does not report either a group contrast or its uncertainty for the primary outcome. It is therefore not possible to assess the observed direction, magnitude, or precision from this record.
A confidence interval is a method for expressing uncertainty around an estimate. In general, its interpretation depends on the sampling process and model assumptions, and it does not mean that the true value has a particular probability of lying within a specific calculated interval. A p-value is a measure of how compatible data are with a null hypothesis under a specified statistical model. It is not a measure of effect size, clinical importance, or the probability that the null hypothesis is true. No confidence interval or p-value for the primary comparison is reported in the registry record.
Why do repeated measurements need a clear analysis plan?
The primary endpoint lists 12 wks and 6 mos. When outcomes are measured at multiple times, analysis choices can include separate comparisons at each time, a joint model of repeated observations, or a designated primary time point. These choices answer different questions and can use the data differently. Repeated observations from the same person are generally related, so an analysis should account for that dependence if it models them together. The registry record does not report which approach was used, whether the time points were analyzed separately, or how missing assessments were handled.
In general, repeated-measures models can use information across follow-up while representing within-person correlation. Their validity depends on the model structure and assumptions about the unobserved data. Separate time-point analyses can be easier to interpret, but testing several time points can raise multiplicity concerns. The registry does not report a statistical analysis plan that would resolve these questions for the VSP outcome.
What do the planning assumptions mean?
The record describes a sample-size planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect, and that non-time-to-event planning values are expressed as participants per arm. These are planning assumptions, not observed outcomes and not a statement of the trial’s original design rationale. The registry does not report the original sample-size justification. Because it provides no single observed primary effect to interpret, the planning illustration cannot establish how adequately the study was powered for its primary question.
In general, a sample-size calculation estimates the amount of information needed for a chosen effect, significance threshold, power target, allocation, and model. Changing the effect size or assumptions changes the resulting planning requirement. Such a calculation is not “observed power” and cannot substitute for the estimated effect and uncertainty from the trial data. The registry record does not report a trial-specific statistical plan or an analysis result from which to assess those quantities.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary outcome with assessment timeframes of 12 wks and 6 mos, as well as secondary outcomes covering cognitive tests and daily functioning. Evaluating several outcomes or time points can create multiplicity: when many statistical comparisons are made, the chance of at least one apparently unusual result can increase. In general, a prespecified testing hierarchy or adjustment procedure can help define how multiple results should be interpreted. The registry record does not report whether such a plan was used, which time point was primary, or whether any multiplicity adjustment was applied.
The record identifies 8 outcome measures overall, while the named secondary outcomes are Clinical Dementia Rating (CDR) Scale, Mini-Mental State Examination (MMSE), Hopkins Verbal Learning Test (HVLT), Boston Naming Test (BNT), Rey Complex Figure Task (Rey), Anagrams, and Instrumental Activities of Daily Living Scale (IADLS). How the listed outcomes relate to the reported total is not reported in the registry record. No results or analysis details for the secondary outcomes are reported.
Missing-data handling is also not reported in the registry record. It does not state how incomplete follow-up, missed assessments, withdrawal, or unavailable test scores were addressed. In general, missingness can affect both the amount of information and the validity of a comparison, particularly when the reasons for missing data are related to participants’ outcomes or treatment assignment.
The analysis population is not reported in the registry record. It is not clear whether analyses were based on assignment as randomized, participants who followed the intervention, or another defined group. The enrollment figure alone cannot establish who contributed to any outcome analysis. Without a stated population, missing-data approach, and multiplicity plan, the registry record does not support a detailed assessment of the analysis choices or their consequences.
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 |
|---|---|---|---|
| Elderberry Juice | 0 | 11 | 0.0% |
| Placebo | 0 | 13 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Elderberry Juice | 0 of 11 |
| 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 |
|---|---|
| Elderberry Juice | 0 of 11 |
| Placebo | 1 of 13 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Elderberry Juice | Placebo |
|---|---|---|---|
| Non-serious adverse event | Skin and subcutaneous tissue disorders | 0 of 11 | 1 of 13 |
The registry reports serious adverse events for the elderberry juice and placebo groups, with 11 and 13 participants at risk, respectively. The serious adverse event counts are 0 in the elderberry juice group and 0 in the placebo group. The record also lists other, non-serious adverse events: 0 in the elderberry juice group and 1 in the placebo group. Deaths are recorded as 0 in each group.
These figures describe the counts and at-risk denominators recorded for the safety outcomes; they do not establish that every participant was observed for the same duration or that all events were captured in the same way. The registry does not report event descriptions, severity grading for non-serious events, relatedness to the intervention, timing, or reasons for any difference between the safety denominators and the enrollment figure. Those details are not reported in the registry record.
In general, a zero count in a trial record means that no event of that category was reported for the specified group and observation period. It does not prove that the underlying risk is zero. Safety comparisons also depend on the amount of observation, completeness of reporting, and how adverse events were defined and collected. These counts should be read as descriptive registry information, not as a definitive comparison of safety between interventions.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, quadruple-masked, parallel-group trial was registered as completed and that its primary outcome concerned change on a timed visuospatial problem-solving task. It also describes the intervention and placebo regimens and lists additional cognitive and daily-function measures. These details explain the research question and the broad design, but they do not show what happened to participants’ scores.
The registry does not report a single primary-outcome comparison, an effect estimate, a confidence interval, or a test result. It therefore does not establish the direction, size, or precision of any difference between groups on the primary measure. It cannot support a claim that elderberry juice improved, worsened, or had no effect on performance. Absence of a reported result is not equivalent to a finding of no difference.
The result gap also limits interpretation of the secondary outcomes. Although the record names several measures, it does not report estimates or analysis results for them. Their inclusion indicates domains of interest, not evidence of benefit or lack of benefit. The safety counts are descriptive and sparse; they do not establish the absence of risk or provide a complete account of adverse events.
In general, an effect estimate answers what difference was observed under a defined analysis, while its uncertainty indicates how precisely that difference was estimated. The meaning of a result also depends on the outcome’s scoring direction, the time point, the population analyzed, and the handling of incomplete data. Those elements are not fully reported for this trial. Readers should distinguish the study’s design and intended measurements from conclusions that would require posted outcome data.
The registry record is consequently useful for identifying the trial’s intended comparison and areas of uncertainty in reporting. It is not sufficient to determine the observed effect on cognition or inflammation. In particular, the trial title mentions inflammation, but the primary endpoint information in the record concerns visuospatial problem solving, and no inflammation result is reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of why a clearly named endpoint is not enough to evaluate a clinical study. The record identifies a timed problem-solving measure, describes its direction, and lists assessment timeframes. Those details help define what was intended to be measured. Yet a reader also needs the outcome estimates and analysis choices to understand what the observations show. Those results are not reported in the registry record as a single primary comparison.
The multiple assessment timeframes make the estimand especially important. An estimate at 12 wks and one at 6 mos could answer different questions, and a combined analysis would require an explicit method for accounting for repeated measurements. The record does not specify the primary time point or approach. This illustrates how prespecification helps readers distinguish the main question from additional analyses and assess multiplicity.
The record also illustrates the difference between design description and evidence about outcomes. Randomization and masking are relevant design features, but their labels do not replace information about the implemented procedures, analysis population, missing data, or results. Similarly, a planning illustration based on an observed effect is not a substitute for reporting the effect estimate and its uncertainty. Sample-size calculations are planning tools, not a measure of whether a result was observed or precise.
For biostatisticians and clinical researchers, the key lesson is that interpretability depends on a traceable path from the question to the outcome definition, analysis population, model, and reported estimate. When any of these links is absent, readers should limit conclusions to what the record actually documents. In this case, that permits a description of the randomized comparison and endpoint, but not an assessment of the primary outcome’s observed effect.
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 absence of a single reported primary-outcome comparison. Although the registry identifies the VSP as primary, the outcome has assessment timeframes of 12 wks and 6 mos, and the record indicates that it has not been reduced to one comparison. No estimate or uncertainty measure is reported. This prevents evaluation of the observed direction, size, and precision.
The endpoint description does not fully resolve the analysis question. It says change in score is the outcome, but does not define the baseline reference, exact change calculation, or treatment of repeated measurements. The outcome label also uses VSP, while the unit refers to VPS Total Score; that naming difference is not clarified in the registry record. These ambiguities make it harder to identify the precise estimand from the record alone.
Details that would help assess internal validity are not reported in the registry record, including the random-sequence method, allocation concealment, the roles covered by quadruple masking, the analysis population, missing-data handling, and the statistical model. The record does not describe participant characteristics or eligibility criteria beyond the condition of mild cognitive impairment. The enrollment figure does not reveal the number contributing to each endpoint analysis.
The registry lists secondary outcomes but does not report their results or how they relate to the stated total of outcome measures. It also does not report a multiplicity plan or the original sample-size justification. Safety information is limited to event counts and at-risk denominators; event details, exposure duration, and collection procedures are not reported. These limits are specific to what the registry record documents and do not determine what may be available in other study materials.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Effect of Elderberry Juice on Cognition and Inflammation in Patients With Mild Cognitive Impairment — NCT02414607.
- Registry record last updated 2022-06-23; status last verified 2022-05.
- Results first posted 2022-06-23.
- 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
The registry record describes a completed randomized, quadruple-masked, parallel-group Phase 1 and Phase 2 trial sponsored by the University of Missouri-Columbia. It lists enrollment of 24 and compares elderberry juice with placebo in people with mild cognitive impairment. The intervention descriptions specify 5ml diluted in 8oz of water, 3 times per day for three months.
The primary outcome is the Visuospatial Problem Solving Battery, described as a timed task for non-memory impairments, with lower times better. Assessment timeframes are 12 wks and 6 mos. The record does not report a single primary comparison or its estimate. It names additional cognitive and daily-function outcomes but does not report their analysis results. Serious adverse event counts are 0 in each group; other adverse event counts are 0 for elderberry juice and 1 for placebo. The registry record does not report the analysis population, missing-data approach, or detailed statistical plan.