Serious Game-based Interventions in Patients With Mild Cognitive Impairment Outside the Clinic: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Serious Game-based Interventions in Patients With Mild Cognitive Impairment Outside the Clinic (NCT04920123), a randomized na study. The primary outcome is Change in Montreal Cognitive Assessment (MoCA).

2. Clinical Question

3. Trial Design

The registry describes a randomized, double-masked crossover study of Neuro-World in people with mild cognitive impairment. It lists an overall enrollment of 19 and a completed study status. The study start date is 2022-02-17, and the primary completion date is 2025-03-31. The registry lists the sponsor as the University of Massachusetts, Amherst.

A crossover design means participants may receive more than one study condition in different periods, rather than remaining in a single group throughout. However, the registry record does not report the sequence assigned to participants, the duration or order of any periods, a washout interval, or how period and carryover effects were addressed. It also does not identify which parties were masked. Those details matter when assessing whether a simple comparison of group summaries reflects the intended crossover analysis.

The intervention description specifies home play for 30 minutes per day, twice a week for 12 weeks, with 24 sessions. The comparator description says participants did not engage in cognitive training. The record does not report actual adherence, the number of completed sessions, or whether the planned conditions were followed by all participants.

The posted primary summaries list 12 participants for each group, while overall enrollment is 19. Those figures do not by themselves explain the analysis population or how participant observations were handled in a crossover design. The registry record does not report a participant flow or an explanation of the relationship between enrollment and the outcome sample sizes. A trial protocol, original sample-size justification, and detailed statistical analysis plan 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.

Before assignment: Fifteen participants were enrolled and randomized into two groups. Three participants discontinued participation during the study. No significant events such as washout or run-in periods occurred prior to group assignment. Four caregivers were enrolled to assist with technical arrangements and help manage study logistics. Two caregivers discontinued participation during the study after the participants they were assisting withdrew.

First Intervention (12 Weeks)

Reasons for not completing this period:

Second Intervention (12 Weeks)

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.

6. Primary Endpoint

The registry lists the primary outcome as Change in Montreal Cognitive Assessment (MoCA), measured over 12 weeks.

The primary endpoint is change in Montreal Cognitive Assessment (MoCA) score from baseline to 12 weeks. It is a continuous measure reported as a mean, with standard deviation describing variability among the observations. MoCA scores range between 0 and 30, and higher scores indicate better cognitive function. The endpoint therefore describes change in a cognitive assessment over the stated period, not a direct measure of every aspect of daily function or quality of life.

Using change from baseline focuses the comparison on how scores shifted during the 12-week period. Comparing mean changes between the intervention conditions can describe whether the average shift differed between the Game Intervention and No Intervention groups. The measure is useful as a defined and common outcome for assessing cognitive function, but the registry does not state what magnitude of change would be clinically important or how score changes correspond to a meaningful difference in everyday life.

The summaries report a mean change of -2.0 for the Game Intervention group and 2.8 for the No Intervention group, with standard deviations of 3.24 and 1.88, respectively. These are group-level summaries. They do not show the range of individual participant changes, and the posted registry analysis does not explain how the crossover structure was incorporated into the primary comparison.

7. Results Posted in the Registry

• No Intervention: mean 2.80 versus -2.00 on control; difference 4.80 (95% CI 2.68 to 6.92), standardized effect d = 1.81; z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Change in Mini-Mental State Examination (MMSE)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • No Intervention: mean 0.50 versus 0.50 on control; difference 0.00 (95% CI -1.60 to 1.60), standardized effect d = 0.00; z-test p = 1.000.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between No Intervention and the control. The interval gives the range of effects that remain compatible with the data.

Change in Digit Forward Span (DFS)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • No Intervention: mean 0.80 versus -0.20 on control; difference 1.00 (95% CI -0.48 to 2.48), standardized effect d = 0.54; z-test p = 0.186.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between No Intervention and the control. The interval gives the range of effects that remain compatible with the data.

Change in Digit Backward Span (DBS)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • No Intervention: mean 1.40 versus -1.10 on control; difference 2.50 (95% CI 1.28 to 3.72), standardized effect d = 1.64; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for No Intervention than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The registry names six secondary outcomes: change in Mini-Mental State Examination, Digit Forward Span, Digit Backward Span, Geriatric Depression Scale, the Short Form 36 Mental Component Summary Score, and the Lawton-Brody Instrumental Activities of Daily Living Scale. Numeric group summaries and comparisons are posted for the first three. Numerical results for the other three are not reported in the registry record represented by these results.

Across the secondary outcomes with numeric summaries, the pattern is not uniform: one recalculated group contrast is zero, while the others differ in magnitude and precision. The sponsor’s posted one-sided tests also do not align uniformly with the simple recalculations. This mix does not provide a single, consistent secondary-outcome picture that can resolve the primary-analysis discrepancy. The secondary measures cover different aspects of cognition, mood, and functioning, so they are not interchangeable replications of the MoCA endpoint.

Secondary results generally carry less evidential weight when many outcomes are examined without a reported plan for controlling multiplicity. Testing multiple outcomes increases the chance that some comparisons will appear unusual by chance. The registry record does not report a multiplicity adjustment or identify a hierarchy for interpreting the secondary outcomes. The secondary analyses should therefore be read as exploratory signals rather than as independent confirmation of the primary finding.

The posted secondary results do not establish whether changes in other measures correspond to a meaningful change in MoCA or daily life. Their interpretation is further limited by the unreported handling of crossover periods, missing observations, and analysis populations. The record’s listed outcomes indicate what was assessed, but the incomplete numerical reporting does not support a comprehensive account of all six secondary endpoints.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Change in Mini-Mental State Examination (MMSE)
• Change in Digit Forward Span (DFS)
• Change in Digit Backward Span (DBS)
• Change in Geriatric Depression Scale (GDS)
• Change in Short Form 36 (SF-36) Mental Component Summary Score
• Change in Lawton-Brody Instrumental Activities of Daily Living Scale (IADL)

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: each participant has a MoCA score, and the registry reports mean change and standard deviation for each group. A mean describes the group’s average change. A standard deviation describes the spread of individual observations around that average; it is not the uncertainty of the mean or the uncertainty of the difference between groups. The Game Intervention group has a mean change of -2.0 and standard deviation of 3.24, while the No Intervention group has a mean change of 2.8 and standard deviation of 1.88.

What the recalculated contrast represents

The unadjusted recalculation compares the two posted means by subtracting the Game Intervention mean from the No Intervention mean. The resulting mean difference is 4.8 points, with a confidence interval from 2.681 to 6.919 and an unadjusted p-value < 0.001. This calculation uses only the group summaries and does not adjust for other variables or account for the crossover design as described in the registry. It is a straightforward comparison of the posted summary statistics, not a reproduction of a more detailed trial model.

The direction of a contrast depends on which group is subtracted from which. A positive value for the stated contrast means the No Intervention group’s mean change is higher than the Game Intervention group’s mean change. This numerical direction does not establish why scores changed, whether the difference is clinically important, or whether the analysis matches the study’s intended estimand.

Why the crossover structure matters

In a crossover trial, participants can contribute observations under more than one condition. Their outcomes across conditions may be related because they come from the same people. A statistical analysis may need to account for that pairing, the order of treatments, period effects, and the possibility that an earlier condition affects a later one. These are general considerations for crossover studies. The registry record does not report the period-specific results, participant sequences, washout details, or the method used to address these features.

The simple recalculation treats the available group summaries as the basis for a basic two-group comparison. The record does not state whether the posted summaries are period-specific, represent participant-level changes after combining periods, or were produced using a crossover model. Without that information, readers cannot determine how the recalculation relates to the randomized treatment sequence or whether its assumptions correspond to the trial design.

How to interpret the p-values

A p-value describes how surprising data at least as discrepant as those observed would be under a specified statistical model and null hypothesis. It is not the probability that the null hypothesis is true, nor does it measure clinical importance. The unadjusted recalculated p-value for the primary comparison is < 0.001. The registry’s reported primary analysis is a one-sided t-test for superiority with p = 0.997. These results are not interchangeable: they come from different analyses or directions, and the record does not give enough detail to reconcile them. Given the discrepancy, the sponsor’s own analysis takes precedence.

A one-sided test evaluates evidence in a specified direction. The registry does not report the direction of the superiority hypothesis or a numerical test estimate. A result near one under a one-sided test cannot be interpreted fully without knowing that direction and how the test was implemented. It should not be silently replaced with the unadjusted recalculation.

What a confidence interval adds

A confidence interval communicates uncertainty around an estimated contrast, under the assumptions of the method used. The recalculated interval extends from 2.681 to 6.919 for the No Intervention-minus-Game Intervention contrast. Its width reflects limited precision in the available summary data and the variability represented by the group standard deviations. The confidence level and detailed interval method are not reported in the registry record. An interval does not address systematic limitations, including an analysis that might not account for crossover structure.

In general, over-dispersion means that observed variability is greater than a model assumes; when that happens, model-based standard errors and intervals can be too optimistic. The posted summaries include standard deviations, but the registry does not describe a distributional diagnostic or an over-dispersion adjustment. No conclusion about over-dispersion can therefore be drawn from the record.

The sponsor reports t-tests for the primary and some secondary comparisons, but the record does not report a complete statistical plan, analysis population, missing-data method, or adjustment for the multiple outcomes. Those omissions limit the ability to assess model choices and the robustness of inferences. The simple recalculations are useful for understanding the posted means and their unadjusted contrast, but they do not supply the missing analysis details.

11. Confidence Intervals and Precision

The primary recalculated mean difference is 4.8 points for No Intervention minus Game Intervention, with a confidence interval from 2.681 to 6.919. This interval expresses uncertainty around the estimated contrast under the recalculation’s assumptions. Its endpoints are both positive, so the interval does not include a zero difference under that calculation. The associated unadjusted p-value is < 0.001. These quantities describe the recalculation and do not override the sponsor’s reported result.

The group standard deviations are 3.24 for Game Intervention and 1.88 for No Intervention. Standard deviations describe observed spread, while the confidence interval describes uncertainty in the estimated between-group contrast. They answer different questions. The interval’s numerical limits should not be read as the full range of individual participant responses, nor do they describe uncertainty about all possible biases in the trial.

The confidence level and the exact interval method are not reported in the registry record. The posted summaries also do not provide the participant-level observations or explain how within-participant dependence and treatment periods were handled. A confidence interval can be mathematically precise under its assumptions while still leaving uncertainty about whether those assumptions fit the design. Here, the discrepancy with the sponsor’s one-sided analysis is an additional reason to distinguish the recalculated interval from the trial’s reported inference.

Precision is therefore only one part of interpretation. The interval gives a sense of the range of contrasts compatible with the unadjusted calculation, but it cannot establish clinical importance or resolve missing design and analysis information.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not total event counts. They are illustrations computed from the observed effect, not the trial’s original design assumptions. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the target effect is a stated fraction of the observed effect. The registry does not report the original sample-size justification or its assumptions.

For 80% power, the planning figure is the number of participants per arm that would give the assumed design an 80% chance of detecting the specified effect if that effect were the true one, under the calculation’s assumptions. The 90% power column represents a higher target chance of detection and consequently calls for more participants than the 80% target for a given effect. These are prospective planning concepts, not measures of how likely the completed study was to find a result.

The planning rows consider 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect. Smaller target effects are harder to distinguish from random variation, so they require more participants per arm to attain the same power target. The illustrations use a two-arm equal-allocation framework; they do not incorporate the crossover features or other design details that are not reported in the registry record. These figures are not observed power.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 4.800; pooled standard deviation σ = 2.649.
2. n = 2 × (1.96 + 0.842)² × 2.649² / 4.800² = 4.8, rounded up to 5 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 4.8                      # observed difference in means
sigma <- 2.64877330098293                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(4920123)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 5 (80% power), 7 (90% power)
 75% of observed effect: n per arm = 9 (80% power), 12 (90% power)
 50% of observed effect: n per arm = 20 (80% power), 26 (90% power)
power.t.test: 5.9 
Simulated power at n = 5 per arm: 0.703 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The sponsor’s primary analysis is reported as a one-sided t-test for superiority with p = 0.997. The registry does not report a numerical sponsor estimate, confidence interval, test statistic, or the direction specified for the superiority test. The simple recalculation from the posted group means instead gives a No Intervention-minus-Game Intervention difference of 4.8, a confidence interval from 2.681 to 6.919, and an unadjusted p-value < 0.001.

The discrepancy flag indicates that the sponsor’s analysis and the unadjusted recalculation do not agree. The sponsor’s own analysis takes precedence; the recalculation is not a substitute for it. The record does not provide enough information to determine whether differences in test direction, crossover handling, analysis population, or another method choice explain the mismatch, so no cause should be inferred.

The appropriate reading is to keep the two results distinct. The sponsor’s reported result is the trial’s own posted analysis. The recalculation is a simple, unadjusted check of the reported summary means. Since details needed to reconcile them are not reported in the registry record, readers cannot use the recalculation to revise or reinterpret the sponsor’s test as if the analysis were fully specified.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome and six secondary outcomes. It also reports seven analyses overall. Examining several outcomes creates a multiplicity issue: even when no underlying effects are present, repeated testing can make at least one result appear statistically notable by chance. This is a general statistical concern, not evidence that any particular reported result is false.

The registry record does not report whether the analysis plan specified a hierarchy among outcomes, adjusted significance levels, or another method for controlling multiplicity. The primary analysis is described as a one-sided superiority t-test, but the direction of that test and its relationship to the multiple secondary tests are not specified. The unadjusted recalculations should therefore be interpreted as individual comparisons rather than as results protected by a documented family-wise testing strategy.

Missing-data handling is also not reported in the registry record. The posted primary outcome summaries list 12 participants in each group, whereas overall enrollment is 19. This difference cannot be explained from the record alone. It does not establish how many participants completed the study, whether observations were missing, or whether all enrolled participants contributed to each outcome. The registry does not describe imputation, complete-case analysis, or sensitivity analyses.

The analysis population is not reported in the registry record. It is therefore unclear whether the reported comparisons include all randomized participants, only participants with available endpoint data, or another defined population. For a crossover design, the number of participant observations and the treatment-period data included in each analysis are especially relevant. The record does not explain these details, nor does it report an analysis that explicitly accounts for within-participant pairing. These gaps limit assessment of bias, precision, and reproducibility.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry lists zero serious adverse events and zero other adverse events for the Game Intervention group, with 12 at risk in each category. It reports the same counts for the No Intervention group, also with 12 at risk. For caregivers, the record lists zero serious and zero other adverse events, with 2 at risk in each category. Deaths are reported as zero in all three groups.

These are the posted counts for the listed groups and categories. The serious adverse event terms list is empty. The figures do not describe event timing, severity beyond the serious/non-serious categories, or how events were collected. The registry record does not provide further detail about safety monitoring or whether the at-risk counts correspond to the full enrolled population.

Zero events in the posted counts means no events are recorded in these categories for the listed groups; it does not by itself establish that an intervention has no risks. The small listed groups also mean the counts should be read as descriptive safety reporting rather than as a precise estimate of event frequency.

17. What the Result Does, and Does Not, Mean

The primary outcome summaries describe average MoCA changes over 12 weeks in the two intervention conditions. The unadjusted recalculation gives a mean difference of 4.8 points in the direction of higher change in the No Intervention group, with a confidence interval from 2.681 to 6.919. However, the registry’s sponsor-reported one-sided superiority test has p = 0.997, and the record does not explain the disagreement. The sponsor’s own analysis takes precedence over the simple recalculation.

The result does not establish a clinically important difference because the registry does not state a meaningful-change threshold. Nor does it establish that the conditions caused the observed changes: the registry summaries and incomplete analysis details do not rule out other explanations, and they do not show individual participant trajectories. The record also does not explain how the crossover design, treatment periods, or within-participant relationships were handled.

Secondary outcomes provide a mixed and incomplete picture. Numeric summaries are available for three of the six listed secondary outcomes, while the other three are not reported in the registry record. No multiplicity adjustment or outcome hierarchy is described. These secondary results cannot be treated as definitive confirmation of the primary comparison.

The safety counts report no serious or other adverse events and no deaths for the listed groups, but they are small descriptive counts and do not prove an absence of risk. Overall, the registry record documents a completed randomized, double-masked crossover study and its posted results, while leaving important questions about analysis methods, sample size, missing data, and clinical interpretation unresolved.

18. Why This Trial Matters Statistically

This study illustrates why trial design and analysis details matter as much as a numerical result. A crossover design can make efficient use of participants because conditions may be compared within the same people, but the analysis needs to reflect the sequence and repeated measurements. The registry describes the study as crossover yet does not report how its primary comparison handled those features. A basic comparison of group means cannot answer that question.

The primary result also demonstrates why a recalculation should not be confused with the trial’s own analysis. The posted group means yield an unadjusted contrast with a small p-value, while the sponsor reports a one-sided superiority test with p = 0.997. The record does not explain the discrepancy. Preserving that distinction prevents a summary-statistic calculation from being presented as though it were the sponsor’s intended analysis.

Precision and clinical meaning are separate considerations. The recalculated confidence interval quantifies uncertainty under that calculation’s assumptions, but the registry does not state a clinically important MoCA difference. Statistical evidence alone cannot define practical significance. The listed secondary outcomes and safety counts add context, while incomplete reporting, multiplicity, and unclear analysis populations constrain broader conclusions.

For biostatisticians and clinical researchers, the record is a useful example of the need to report the analysis population, crossover handling, missing-data approach, multiplicity plan, confidence-interval method, and original sample-size rationale. Without these elements, readers can describe the posted summaries but have limited ability to verify how the reported inference was obtained or how well it answers the study question.

19. 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 primary limitation is the gap between the crossover design and the analysis detail available in the registry. The record does not report treatment sequences, period-specific outcomes, washout details, or how within-participant dependence and carryover were considered. It therefore cannot establish whether the posted group comparison reflects the planned crossover analysis.

The registry reports 19 enrolled participants, while the primary outcome summaries list 12 in each group. It does not explain the analysis population, participant flow, or how those counts relate to enrollment in a crossover study. Missing-data methods and reasons for unavailable observations are not reported. The original sample-size justification is also not reported in the registry record, so the study’s planned precision and design assumptions cannot be assessed.

The primary sponsor analysis and unadjusted recalculation disagree, and the record lacks the detail needed to reconcile them. The sponsor’s own analysis takes precedence, but its estimate, confidence interval, test direction, and test statistic are not reported. The confidence level and method for the recalculated interval are not stated in the registry record either.

The record lists six secondary endpoints, but numerical summaries are available for only three. A multiplicity strategy and outcome hierarchy are not reported, limiting interpretation of secondary tests. Finally, no threshold for a clinically important MoCA change is provided. These limitations make the posted results difficult to translate into a clear estimate of clinical importance, even though the summary statistics permit a basic unadjusted comparison.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Serious Game-based Interventions in Patients With Mild Cognitive Impairment Outside the Clinic — NCT04920123.
• Registry record last updated 2025-08-07; status last verified 2025-06.
• Results first posted 2025-08-07.
• 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.

23. Record Summary

This completed randomized, double-masked crossover study evaluated home-based Neuro-World cognitive training in participants with mild cognitive impairment. The primary outcome was change in MoCA score from baseline to 12 weeks. The registry lists 19 enrolled participants and reports 12 participants in each primary outcome group.

The posted means were -2.0 for Game Intervention and 2.8 for No Intervention. A simple unadjusted recalculation gives a No Intervention-minus-Game Intervention mean difference of 4.8, with a confidence interval from 2.681 to 6.919 and p < 0.001. The sponsor reports a one-sided superiority t-test with p = 0.997; the discrepancy is not explained, and the sponsor’s own analysis takes precedence.

Important details—including crossover analysis methods, the analysis population, missing-data handling, multiplicity, and the original sample-size rationale—are not reported in the registry record. The posted safety counts list zero serious adverse events, zero other adverse events, and zero deaths in the intervention groups and caregivers.