Brain Health in Midlife: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Brain Health in Midlife (NCT06640842), a registered phase not stated study. The primary outcome is Cardiometabolic Biomarkers - Glucose & Lipids.

2. Clinical Question

The broader study purpose is to learn whether hypertensive disorders during pregnancy affect brain health in midlife. The listed primary outcome is narrower: it assesses differences in cardiometabolic biomarkers between the groups. Those biomarkers may characterize cardiometabolic health, but the registry record does not provide a direct primary measure of brain health or a result connecting the biomarker measure to brain outcomes.

The question is observational in its stated arm structure: participants are classified by pregnancy history rather than by a stated randomized assignment. An observed difference, if reported, would therefore need to be interpreted with attention to how the groups came to differ. The registry record does not report the numerical result needed to describe the direction, size, or precision of any group difference.

3. Trial Design

Brain Health in Midlife (ADORE BRAIN) is listed as a completed study sponsored by the University of Kansas Medical Center. The record gives a start date of 2024-09-23 and a primary completion date of 2025-06-13. Enrollment is listed as 24. The stated purpose is to study brain health in midlife in relation to hypertensive disorders during pregnancy.

The arm descriptions identify women who experienced a hypertensive disorder of pregnancy during ADORE participation and women who had a healthy pregnancy during participation. The registry explicitly indicates that allocation was not stated and that the arms are not a like-for-like control comparison. No randomization procedure, masking approach, or prospective assignment is described in the registry record. These features matter because group differences can reflect characteristics associated with pregnancy history as well as any relationship under study.

The intervention is a combination of tests and biomarkers, described as diagnostic testing. The record does not specify the full testing schedule or identify each test. The primary outcome is measured at baseline and concerns cardiometabolic biomarkers for glucose and lipids. The registry lists 10 outcome measures in total, but the results information does not include analyses for the primary measure.

The adverse-event listings show 12 participants at risk in each arm. These denominators are part of the safety reporting and should not be taken as proof of random allocation or as a complete description of the analysis population for every outcome. The registry does not report the numbers analyzed for the primary outcome, participant flow, withdrawals, or reasons for missing measurements. A protocol-level sample-size justification and details of planned interim analyses are not reported in the registry record.

Because the record describes a completed study but does not provide numerical primary outcome results, completion status alone does not establish what the study found. The design supports a comparison of described groups, but details needed to assess comparability and the analysis remain unavailable.

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

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 Cardiometabolic Biomarkers - Glucose & Lipids, measured over Baseline.

The primary endpoint is titled “Cardiometabolic Biomarkers - Glucose & Lipids.” It is described as an assessment of differences in cardiometabolic biomarkers between women diagnosed with a hypertensive disorder of pregnancy and healthy controls. The unit is mg/dL, the reported summary measure is the mean, and the stated dispersion measure is standard deviation. The timeframe is baseline.

Means describe the average measured value within a group. Standard deviations describe the spread of individual values around that group’s mean; they do not, by themselves, quantify the uncertainty in the estimated mean or in a between-group contrast. A comparison intended to answer the endpoint question would ordinarily need group-specific estimates and an estimate of the difference, with an indication of its uncertainty. Those numerical results are not reported in the registry record.

Glucose and lipid biomarkers are used to characterize cardiometabolic status. In this study, their stated role is to assess group differences, while the broader study purpose concerns brain health in midlife. The registry record does not specify which individual glucose or lipid markers comprise the endpoint, nor does it describe a composite score, threshold, or clinical interpretation rule. It also does not report whether all listed biomarkers were measured or analyzed in the same way.

The baseline timing means the measure is recorded at the stated baseline assessment; the record does not provide a later measurement or a change-from-baseline result for this endpoint. No inference about the magnitude or direction of a difference can be made without the numerical group results and analysis.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical methods help translate measurements from participants into estimates that address a research question. For this study, the primary question concerns cardiometabolic biomarkers measured at baseline in groups defined by pregnancy history. The registry specifies a mean and standard deviation as the intended summaries, but does not report numerical results or the analysis method used to compare groups. The explanations below describe general statistical concepts, not methods confirmed to have been used in this study.

What does a mean describe?

For a continuous measurement, the mean is the arithmetic average of the observed values in a group. It provides a compact description of the group’s central value, but it does not show the full distribution. Two groups can have similar means yet differ in variability, skewness, or the presence of unusually high or low observations. The mean can also be sensitive to extreme values. For that reason, interpreting a mean generally benefits from information about the spread and the distribution of the underlying measurements.

The standard deviation describes how dispersed individual observations are around the group mean. A larger standard deviation indicates more variation among measured participants, while a smaller one indicates that values are more concentrated around the mean. Standard deviation is not the same as the standard error of a mean. The former describes observed participant-level variation; the latter describes uncertainty in an estimated mean under a statistical model. Neither is reported numerically for the primary endpoint in the registry record.

What would a group comparison estimate?

A comparison of group means can be expressed as a contrast: the estimated mean in one group relative to the estimated mean in the other. The contrast’s sign depends on which group is subtracted from which, so the analysis should state its direction clearly. Its magnitude describes the estimated difference in the measured unit. The registry does not provide a contrast, its direction, or its magnitude, so none can be interpreted for this endpoint.

A confidence interval expresses uncertainty around an estimate under the assumptions of the analysis. A narrow interval generally indicates greater precision than a wide interval, although precision does not establish whether an estimate is free of bias or clinically important. If an interval includes values on both sides of no difference, the data may be compatible with effects in either direction under the model. These are general interpretations; no confidence interval is reported for the primary comparison.

A hypothesis test evaluates how compatible observed data are with a specified null hypothesis and model. A p-value is not the probability that the null hypothesis is true, nor is it a measure of effect size. A small p-value does not by itself establish importance, and a larger p-value does not prove that groups are identical. Interpretation should consider the estimate, its uncertainty, study design, and analysis assumptions together. The registry does not report a p-value or a test for the primary endpoint.

Why do study design and assumptions matter?

In a randomized comparison, allocation by chance can support interpretation of group contrasts, subject to conduct and analysis. Here, the registry describes groups according to pregnancy history, says allocation was not stated, and warns that the arms are not a like-for-like control comparison. In general, this means a difference could be influenced by other group characteristics. Adjustment can sometimes address measured characteristics, but cannot automatically remove unmeasured confounding. The registry does not report whether any adjustment was performed or which variables might have been considered.

Statistical models also rely on assumptions about the measurements and their variability. For continuous outcomes, analysts may consider whether the outcome distribution and model errors are adequately represented by the chosen approach. If variability differs substantially between groups, a method that assumes equal variance may give unreliable uncertainty estimates. If a distribution is strongly skewed or contains influential observations, the mean and a conventional model may need careful assessment. The registry does not report diagnostic checks or alternatives used for the biomarker outcome.

Over-dispersion is a general concern in count-data models when observed variation exceeds what a chosen model expects. It is not a specific description of this continuous biomarker endpoint. More broadly, model fit should match the type and distribution of the outcome; the record does not identify a fitted model for the primary measure.

How should planning calculations be read?

The registry describes sample-size illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It also describes planning for stated fractions of the observed effect. These are planning illustrations, not a report of the study’s original sample-size justification. The record does not report a protocol justification or the numerical outputs for these illustrations in the registry record for interpretation.

Power is a design concept: under specified assumptions, it describes the probability that a planned analysis will reject a null hypothesis when a particular effect is present. A planning calculation depends on the assumed effect, variability, analysis, allocation, and significance level. It cannot be interpreted as observed power after the fact, and it does not show what the study found. No observed power should be inferred from the enrollment listing.

Finally, analysis populations and missingness affect interpretation. A result among participants with recorded measurements may differ from the result intended for all enrolled participants if missingness is related to the outcome or group. Methods for handling missing observations should be reported and justified. The registry record does not describe the primary outcome analysis population or missing-data procedures, so these aspects cannot be assessed.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 10 outcome measures. When a study evaluates multiple outcomes or multiple comparisons, the chance of obtaining at least one apparently unusual result can increase if each is tested separately without accounting for multiplicity. General approaches include prespecifying a primary outcome, adjusting inference across a family of tests, or distinguishing confirmatory analyses from exploratory ones. The record identifies a primary outcome, but does not report a multiplicity strategy, the hierarchy of other outcomes, or how any multiple comparisons were handled.

The analysis count is listed as 0, and numerical results for the primary endpoint are not reported. It is therefore not possible to assess whether outcome reporting was complete or whether any multiplicity adjustment was applied. The existence of 10 listed outcome measures alone does not establish how many tests were conducted.

Missing data can affect both the estimate and its uncertainty. If participants with missing measurements differ systematically from those with recorded measurements, an analysis restricted to complete observations may not represent the intended population. General methods can include explicit assumptions about the missingness process and sensitivity analyses; no method is confirmed for this study. The registry does not report missing-data counts, reasons, handling procedures, or sensitivity analyses for the primary outcome.

The record also does not report the analysis population, exclusions, or the number contributing primary endpoint measurements. Enrollment and safety denominators should not be substituted for these details. A protocol, statistical analysis plan, and participant flow information would help clarify prespecification and analysis choices, but these details are not reported in the registry record.

11. 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 safety listings report serious adverse events in the two arms as 0 affected among 12 at risk in the hypertensive disorder of pregnancy arm and 0 affected among 12 at risk in the healthy pregnancy arm. Deaths are listed as 0 in both arms. Other adverse events are also listed as 0 affected among 12 at risk in each arm. No serious adverse-event terms are listed.

These figures describe the events recorded in the registry, not the primary biomarker outcome. A zero count means no affected participants were recorded for the listed category in the reported group; it does not establish that an event was impossible or that all possible events were captured. The registry does not provide further information about event collection, definitions, observation duration, or completeness of reporting.

The at-risk counts are safety denominators and should be read as such. They do not establish the number with evaluable biomarker results, nor do they show that participants were randomized. In particular, the registry states that allocation was not stated. The safety figures therefore offer a limited account of recorded events and do not resolve the study’s primary research question.

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

The record establishes the study’s stated aim, group descriptions, primary endpoint, and completion status. It identifies a baseline comparison of cardiometabolic biomarkers related to glucose and lipids between women with a hypertensive disorder of pregnancy during ADORE participation and women with a healthy pregnancy during participation. It does not report the numerical primary outcome results. The evidence in this record therefore does not indicate whether the measured group means differed, in which direction, or by how much.

Without group estimates and uncertainty measures, the statistical precision of any comparison cannot be judged. It is not possible to determine whether the data are compatible with a wide range of differences or a more narrowly estimated contrast. Nor can statistical significance, if a test had been conducted, be assessed. A missing result is not evidence of no difference.

The study’s broader purpose refers to brain health in midlife, while its listed primary outcome concerns cardiometabolic biomarkers. The registry record does not provide results demonstrating a relationship between those biomarkers and brain health, and it does not report a direct brain-health result as the primary endpoint. The biomarker outcome should therefore be interpreted according to its stated scope rather than as a complete answer about brain health.

The observational group structure also limits causal interpretation. The registry says allocation was not stated and warns that the arms are not a like-for-like control comparison. In general, differences between groups can reflect factors other than the pregnancy history used to define them. The record does not report adjustment methods or enough participant information to evaluate that concern.

The study is listed as completed, with enrollment of 24, but completion and enrollment do not reveal the result or the number analyzed for the primary measure. The safety record lists no affected participants for the specified adverse-event categories, but those listings do not answer the biomarker question. Overall, the registry record describes what was intended to be compared while leaving the primary estimate and its uncertainty unreported.

13. Why This Trial Matters Statistically

This study raises a statistically important question about how to compare groups defined by pregnancy history when the outcome is measured later in life. Such comparisons require clear definitions of the groups, transparent outcome summaries, and careful consideration of whether the groups are comparable. The registry itself flags that the arms are not a like-for-like control comparison, making design and confounding considerations central to interpretation rather than optional technical details.

The primary endpoint also illustrates the distinction between a broad research aim and a specific measurable outcome. The stated aim concerns brain health in midlife, while the primary measure is a mean of cardiometabolic biomarkers for glucose and lipids at baseline. Clearly separating these concepts helps readers judge what a reported analysis can support and what would require different evidence.

Reporting estimates alongside uncertainty is important for continuous outcomes. Group means and standard deviations describe the data, while a contrast and confidence interval can communicate the estimated difference and its precision. Without those results, readers cannot judge the range of differences compatible with the study. The registry’s completed status cannot substitute for transparent reporting of estimates and analyses.

The record lists 10 outcome measures, underscoring the value of prespecified outcome priorities and an explained approach to multiplicity. Information on missing measurements, analysis populations, and statistical methods would also help readers assess whether the reported estimates represent the intended participants and how robust the findings may be. These details are not reported in the registry record.

Statistically, the record is useful for identifying the intended comparison and the limits on what can be concluded. It also shows why a study’s question, design, outcome definition, and reported results must be considered together. With no numerical primary outcome analysis, the principal value for interpretation is the specification of the question and the recognition that its answer remains unreported 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 direct limitation for interpreting this trial is the absence of numerical results for the primary endpoint. The registry lists the measure and its summary format but does not report group means, standard deviations, a between-group estimate, a confidence interval, or a p-value. The primary comparison’s direction, magnitude, and precision are therefore unavailable.

Further design and analysis details are not reported in the registry record. Allocation is not stated, and the record cautions that the arms are not a like-for-like control comparison. The group descriptions do not establish comparability on other characteristics. Adjustment methods, participant characteristics relevant to the comparison, and the analysis model are not reported.

Although enrollment is listed as 24 and the safety denominators are 12 per arm, the number analyzed for the primary measure is not reported. The record does not describe missing outcome measurements, exclusions, withdrawals, or a missing-data strategy. These omissions prevent assessment of whether the participants contributing biomarker data represent the enrolled groups.

The endpoint description refers to glucose and lipid biomarkers but does not identify the individual measures or explain whether they form a composite. The record lists 10 outcome measures but does not report a multiplicity plan or the results for the primary analysis. It also does not report a protocol-level sample-size justification, interim analyses, or a statistical analysis plan.

Finally, the listed primary measure is a baseline cardiometabolic endpoint, while the stated study purpose concerns brain health in midlife. The record does not provide numerical evidence linking the biomarker comparison to a brain-health outcome. These limits mean that conclusions about the primary result or the broader study purpose cannot be drawn from the registry information described.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Brain Health in Midlife — NCT06640842.
• Registry record last updated 2026-07-14; status last verified 2026-06.
• Results first posted 2026-07-14.
• 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.

18. Record Summary

Brain Health in Midlife (ADORE BRAIN), sponsored by the University of Kansas Medical Center, is listed as completed. The registry gives a start date of 2024-09-23, a primary completion date of 2025-06-13, and enrollment of 24. The study’s stated purpose concerns the relationship between hypertensive disorders during pregnancy and brain health in midlife.

The groups are described by pregnancy history: hypertensive disorder of pregnancy and healthy pregnancy. The primary outcome is baseline cardiometabolic biomarkers for glucose and lipids, summarized as a mean with standard deviation in mg/dL. The record lists 10 outcome measures and 0 analyses.

The safety listings report 0 serious adverse events, 0 other adverse events, and 0 deaths in each arm, with 12 at risk in each arm. Numerical results for the primary outcome, its analysis population, and its uncertainty are not reported in the registry record. Allocation is not stated, and the registry cautions that the arms are not a like-for-like control comparison.