Anti-Diabetic Medications to Fight PD and LBD: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Anti-Diabetic Medications to Fight PD and LBD (NCT06263673), a randomized phase 4 study. The primary outcome is Change in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Score.

2. Clinical Question

The clinical question combines a short-term neurological outcome with a tolerability question. Those are related but distinct: a change in a disease rating scale addresses measured symptoms or severity, while adverse-event reporting describes harms observed during the study. The registry record lists secondary outcomes of change in fasting glucose and orthostatic blood pressure, but it does not give their numerical results in the information available for interpretation. The listed study arms and outcome definitions establish what was intended to be examined, not what was demonstrated.

3. Trial Design

This was a phase 4 randomized, double-masked, parallel-group study sponsored by Mayo Clinic. The registry record lists an enrollment of 18 and describes three arms: sitagliptin, dapagliflozin, and placebo. Each arm description specifies treatment for approximately 4 weeks. The design therefore compares participants assigned to separate treatment groups over a short treatment period; it is not described as a crossover study in which participants switch among treatments.

The record lists the study as completed. Its start date is 2024-05-07, and its primary completion date is 2025-01-08. These dates describe the registry timeline and do not by themselves establish when analyses were conducted or when results became available. The allocation ratio, the number assigned to each arm, and details of the randomization process are not reported in the registry record.

Double masking means that masking was part of the stated design, but the record excerpt does not identify which roles were masked or how masking was maintained. Further details about treatment administration, adherence, concomitant care, protocol deviations, and follow-up beyond the approximately 4-week treatment period are not reported in the registry record. The registry lists Parkinson’s disease and Lewy body dementia as conditions; it does not provide enough information to describe the enrolled participants’ diagnostic composition or other baseline characteristics.

The planned primary measure was change in MDS-UPDRS score from baseline to 4 weeks. Change in fasting glucose and change in orthostatic blood pressure were listed as secondary outcomes. The record lists four outcome measures and eight analyses, but does not give enough detail to map every analysis to an outcome, treatment comparison, or analysis population. A single primary treatment comparison is not presented in the record, so the design description should not be mistaken for a complete account of the analysis actually performed.

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: 5 subjects screen failed prior to randomization assignment.

Overall Study

Reasons for not completing this period:

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 Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Score, measured over Baseline, 4 weeks.

The primary endpoint is change in the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) score between baseline and 4 weeks. The scale is intended to measure the severity and progression of Parkinson’s disease. Its four subscales cover non-motor experiences of daily living, motor experiences of daily living, motor examination, and motor complications. The record describes question counts of 13, 13, 33, and 6, respectively, and gives subscale score ranges of 0-52, 0-52, 0-132, and 0-24.

Each item is rated from 0 (normal) to 4 (severe), with higher subscale scores indicating more severe Parkinson’s disease. The scale is used because it covers multiple dimensions of disease-related experience and examination rather than relying on a single symptom. A change score compares a participant’s measured score at follow-up with the baseline score, making the outcome relevant to short-term change over the treatment period.

The registry specifies the summary parameter as a median and the dispersion as a full range. This describes the intended way to summarize the endpoint, not the numerical findings. The primary outcome description does not provide the medians, ranges, group-specific changes, or a treatment-effect estimate. Those values are not reported in the registry record. Consequently, the endpoint’s definition can be explained, but its observed magnitude and the precision of any treatment comparison cannot be assessed from the posted primary outcome information.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The record describes randomization, double masking, and a parallel-group design. Randomization is generally used to reduce systematic differences between treatment groups at assignment, while masking can reduce the influence of treatment knowledge on participant behavior, care, or outcome assessment. These are general statistical and design principles; the record does not describe the randomization procedure, masking roles, or implementation details. The allocation ratio is also not reported in the registry record.

What does the endpoint summary mean?

The primary outcome is change in MDS-UPDRS score from baseline to 4 weeks, with the summary parameter specified as a median and dispersion specified as a full range. A median is a robust measure of the center of a distribution: it identifies the middle value after observations are ordered. A full range communicates the span from the smallest to the largest observed value, but can be strongly affected by extreme observations. These summaries describe the distribution of observations; they are not, on their own, an estimate of the difference between treatment and placebo.

For a comparative analysis, the treatment effect could be expressed using a difference between groups or another prespecified contrast. The registry record does not report a single primary comparison, a numerical contrast, or an interval expressing its uncertainty. It also does not describe whether the comparison used participant-level change scores, an adjusted model, or another method. Those analytical choices are not reported in the registry record and should not be inferred from the endpoint summary format.

Why does uncertainty matter?

A confidence interval is a statistical range of values compatible with the data under a specified analysis and its assumptions. It helps readers assess how precisely an effect is estimated, whereas a point estimate alone gives only one summary value. No confidence interval for the primary comparison is reported in the registry record. A p-value, if available, would address compatibility with a null hypothesis under an analysis model; it would not by itself measure clinical importance or precision. The primary comparison’s p-value is not reported in the registry record.

Small studies can yield imprecise estimates because there is limited information with which to distinguish a treatment effect from random variation. This is a general statistical consideration, not an estimate of this study’s precision. Enrollment was 18, but the primary outcome group sizes and analyzed sample are not reported in the registry record. Thus, no precision calculation for the primary endpoint can be made from the record’s descriptive information.

How should planning illustrations be read?

The planning assumptions described for sample-size illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They define the effect to detect as a stated fraction of the observed effect. These are planning assumptions, not a description of the trial’s own design rationale. The sample-size illustrations are not observed power, and they do not show that the trial had a particular probability of detecting an effect. The record does not report the trial’s sample-size justification. Because the primary outcome is not reduced to a single comparison, a particular primary effect estimate and its planning interpretation are not available from the record.

For a continuous outcome, a sample-size illustration generally depends on the target effect, variability, significance level, power target, and allocation assumptions. A normal approximation relies on conditions that may be less dependable with limited data or markedly non-normal outcomes. This is general background; it does not establish which model was used for the endpoint analysis. No variability estimate or final primary comparison is reported in the registry record.

What can be concluded from the analysis listings?

The record lists four outcome measures and eight analyses. These counts indicate that multiple outcomes or analyses were registered, but they do not identify each analysis, its statistical model, or whether analyses were prespecified or exploratory. The study’s analysis plan, including adjustment variables, handling of repeated measurements, treatment of outliers, and any interim analyses, is not reported in the registry record. It would therefore be inappropriate to attribute a specific model or decision rule to the investigators.

General statistical principles can clarify why these details matter. An analysis plan specifies how outcomes, treatment groups, missing observations, and uncertainty are handled. Prespecified choices help limit selective emphasis on favorable findings, while transparent reporting lets readers assess whether the analysis matches the question. Those principles do not reveal what procedures this study used. In particular, a listed outcome and an analysis count are not enough to reconstruct the model or determine the strength of evidence for a treatment contrast.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists four outcome measures and eight analyses, including the primary MDS-UPDRS change outcome and secondary outcomes of change in fasting glucose and orthostatic blood pressure. When several outcomes, time points, or treatment comparisons are assessed, the chance of at least one apparently unusual result can increase. General approaches to this issue include designating a primary comparison, adjusting inference across multiple tests, or clearly separating confirmatory from exploratory analyses. The record does not report whether any such multiplicity strategy was used.

The primary outcome information is not reduced to one comparison. The analysis plan, including any prespecified hierarchy among outcomes or comparisons, is not reported in the registry record. The record also does not identify which of the eight analyses correspond to which outcomes or treatment groups. Consequently, the multiplicity implications cannot be reconstructed from the analysis count alone.

Missing-data handling is not reported in the registry record. The record does not state how missing endpoint measurements, withdrawals, or incomplete follow-up were handled, or whether imputation or another method was used. Analysis populations are also not reported: it is not clear from the available information which participants were included in the primary analysis or how participants with protocol deviations were treated.

These omissions limit interpretation because analysis choices can affect both the estimated treatment contrast and its uncertainty. They do not prove that the analysis was inappropriate; they mean that the registry information does not allow readers to evaluate those choices. The reported enrollment and safety denominators should not be used as substitutes for an endpoint-specific analysis population.

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 adverse-event information lists 4 participants at risk in the sitagliptin group, 4 in the dapagliflozin group, and 5 in the placebo group. It reports 0 serious adverse events and 0 other adverse events in each listed group, and 0 deaths in each group. No serious adverse-event terms are listed. These are the counts recorded for the stated at-risk groups; they are not a comparison adjusted for differences between groups.

Zero recorded events in a small group does not establish that the underlying risk is zero. It means that no events of the reported category were recorded among the listed participants during the observation represented by the registry entry. The duration and completeness of safety follow-up beyond the approximately 4-week treatment period are not reported in the registry record. The record also does not provide event definitions, severity grading details, or a fuller account of how adverse events were collected.

These figures should be read as limited descriptive safety information, not as proof of equal safety or proof that no harm occurred. The registry’s at-risk counts are distinct from the total enrollment of 18, and the record does not explain the difference. Comparisons based on these counts would be particularly uncertain without further details about follow-up, participant disposition, and event ascertainment.

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

The record establishes that a randomized, double-masked, parallel-group study of sitagliptin, dapagliflozin, and placebo was completed, with an approximately 4-week treatment period and MDS-UPDRS change specified as the primary endpoint. It also records a planned focus on tolerability and neurological effects in Parkinson’s disease and Lewy body dementia. These registry entries describe the study question and structure, not the outcome of the comparison.

The primary endpoint values and a single treatment comparison are not reported in the registry record. As a result, the posted information cannot show whether MDS-UPDRS scores changed differently between any drug group and placebo, how large a difference may have been, or how precisely any difference was estimated. It cannot support a conclusion that a treatment did or did not produce a neurological effect. The absence of a reported estimate is not evidence that the effect was zero.

Similarly, the limited adverse-event counts cannot establish that a treatment was safe or that risks were identical between groups. The record lists no serious or other adverse events and no deaths among the reported at-risk counts, but the groups are small and the extent of safety follow-up is not described in detail. The secondary outcomes are named, but their numerical findings are not reported in the record information available for interpretation.

General statistical interpretation separates the existence of a study, its intended outcome, and its estimated result. A protocol question can be important even when the posted results do not permit an answer. To evaluate the comparative evidence, readers would need group-level results, a clearly specified treatment contrast, uncertainty estimates, and analysis details. Without them, the appropriate conclusion is limited: the registry documents the design and outcome definitions, but does not provide enough primary outcome information to determine the comparative neurological result.

13. Why This Trial Matters Statistically

This study is statistically notable because it places two active treatments and placebo in a randomized, double-masked, parallel-group design, while specifying change in a multidomain disease rating scale as its primary outcome. That structure creates a comparative question, but a comparison becomes interpretable only when the results identify the groups being contrasted and quantify the estimated effect and its uncertainty.

The registry record reports enrollment of 18 and lists multiple outcomes and analyses. With limited enrollment, estimates may be imprecise; this is a general consideration rather than a calculated property of the primary result. The record does not provide endpoint-specific group sizes or a numerical effect estimate, so the degree of precision cannot be evaluated. The record’s planning assumptions should likewise be understood as illustrations, not as evidence of observed power or proof that the enrolled sample was adequate for a particular effect.

The use of medians and full ranges is also relevant. These summaries can communicate the center and spread of observed scores, but they do not alone answer whether treatments differ. Comparative estimates and uncertainty are needed to assess the evidence. The record does not report a single reduced primary comparison, which prevents readers from linking the endpoint definition to a quantitative treatment conclusion.

More broadly, this record shows why transparent reporting of analysis populations, missing-data handling, multiplicity procedures, and treatment contrasts matters. Such details help distinguish a prespecified test from exploratory analyses and clarify the strength and limits of inference. Their absence from the registry information does not establish what happened in the analysis, but it constrains what readers can assess statistically.

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 principal limitation for interpretation is that the primary endpoint is defined, but its numerical results and a single treatment comparison are not reported in the registry record. No group-specific medians or full ranges, effect estimate, confidence interval, or p-value for the primary comparison is available in the record information. Therefore, neither the direction nor the precision of the comparative result can be assessed.

Enrollment was 18, and the record does not describe the number assigned to each treatment arm or the number included in the primary analysis. The adverse-event section lists at-risk counts of 4, 4, and 5, but does not explain how those counts relate to enrollment or to endpoint follow-up. Baseline characteristics and the diagnostic distribution between Parkinson’s disease and Lewy body dementia are not reported in the registry record, limiting assessment of the participants represented by the endpoint.

The treatment period is described as approximately 4 weeks. The registry record does not provide information about longer-term outcome measurement or safety follow-up. The randomization procedure, masking details, adherence, participant disposition, and protocol deviations are also not reported in the registry record. The analysis plan, missing-data methods, analysis populations, multiplicity approach, and sample-size justification are not reported in the registry record.

These limitations concern what can be established from the registry information. They do not show that a particular design or analysis procedure was absent; they indicate that it cannot be evaluated from the record. The listed zero adverse-event counts should also be interpreted in light of the small reported at-risk groups and limited follow-up detail. Taken together, the available information supports a clear description of study intent and design, but not a firm statistical conclusion about comparative efficacy or safety.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Anti-Diabetic Medications to Fight PD and LBD — NCT06263673.
• Registry record last updated 2026-01-28; status last verified 2026-01.
• Results first posted 2026-01-28.
• 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

NCT06263673, titled Anti-Diabetic Medications to Fight PD and LBD, is a phase 4 randomized, double-masked, parallel-group study sponsored by Mayo Clinic. The registry lists Parkinson disease and Lewy body dementia as conditions and an enrollment of 18. The study status is completed; the listed start date is 2024-05-07 and the primary completion date is 2025-01-08.

The three listed groups received sitagliptin, dapagliflozin, or placebo for an approximately 4-week treatment period. The primary outcome was change in MDS-UPDRS score from baseline to 4 weeks, summarized by median and full range. Secondary outcomes included change in fasting glucose and orthostatic blood pressure.

The registry record does not reduce the primary outcome to one comparison or report a numerical treatment-effect estimate. It lists zero serious adverse events, zero other adverse events, and zero deaths in the reported at-risk groups. The information supports a description of the study’s design and aims, but does not provide enough primary outcome results to assess comparative neurological effects.