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 Magnesium L-Threonate for the Enhancement of Learning and Memory in People With Dementia (NCT02210286), a na na study. The primary outcome is Change From Baseline in Cognitive Function.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02210286 |
| Phase | NA |
| Condition | Dementia, Alzheimer's Disease |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 17 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Stanford University |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns people with mild to moderate dementia. Dementia and Alzheimer’s Disease are listed as conditions. The registry record does not report further eligibility details or describe the enrolled participants’ characteristics.
Intervention
The intervention is Magtein, a dietary supplement. The registry description says participants take 1800 mg/day orally for 60 days, with two pills 2 hours before bedtime and one pill in the morning. Each pill contains 600 mg of MgT-1219.
Comparator
No comparison group is described. The study is listed as a single-group model, with allocation recorded as NA and no masking. The registry record does not report a placebo or usual-care comparator.
Primary question
The primary outcome is change from baseline in cognitive function, assessed using domain-specific composite scores from ADAS-COG, MMSE, RBANS, and WAIS-IV. The stated timeframe is baseline and 6 months. The registry record does not report numerical outcome results or an analysis of change, so it does not establish the direction or precision of any observed cognitive change.
3. Trial Design
This completed study was registered as a single-group investigation of Magnesium L-Threonate in people with mild to moderate dementia. Enrollment is listed as 17. The record lists Stanford University as sponsor, a start date of 2014-07, and a primary completion date of 2016-04. Its status is COMPLETED.
There is no randomized comparison described: allocation is listed as NA, the model is SINGLE GROUP, and masking is NONE. The arm description names Magtein and states that all participants take the supplement. Thus, the design does not provide a concurrent control group against which changes in the treated group can be compared. Without such a comparison, a change over time cannot by itself distinguish an intervention-associated change from natural variation, changes in the underlying condition, repeated-test effects, or other influences. These are general interpretive considerations, not findings about this study.
The intervention description specifies oral dosing of 1800 mg/day for 60 days, using pills containing 600 mg of MgT-1219. The primary outcome timeframe is described as baseline and 6 months. The record does not explain how the 60-day dosing schedule relates to the 6-month outcome assessment, or give more detail about the timing of assessments.
The record lists 5 outcome measures and 0 analyses. It does not report a statistical analysis plan, participant flow, adherence, or the characteristics of the enrolled group beyond the study’s dementia population. The registry’s completed status describes the study record; it does not, on its own, establish that outcome results or a full analysis are available.
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 | Magtein |
|---|---|
| STARTED | 17 |
| COMPLETED | 15 |
| NOT COMPLETED | 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 | Magtein Subjects |
|---|---|---|
| Participants analysed | 17 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 |
| Age, Categorical: >=65 years | Participants | 17 |
| Age, Continuous | years | 77.0 (SD 5.86) |
| Sex: Female, Male: Female | Participants | 7 |
| Sex: Female, Male: Male | Participants | 8 |
| Region of Enrollment: United States | participants | 17 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Cognitive Function, measured over Baseline and 6 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is titled Change From Baseline in Cognitive Function. It concerns neurocognitive assessment using domain-specific composite scores for four areas: ADAS-COG, MMSE, RBANS, and WAIS-IV. The registry describes the outcome as a mean with standard deviation and gives the timeframe as baseline and 6 months.
The instruments cover different scales and score ranges. The listed ranges are 0 to 70 for ADAS-COG, 0 to 30 for MMSE, 40 to 160 for RBANS, and 85 to 115 for WAIS-IV. The record states higher scores are better for each instrument. These details identify the direction and scale of the component measures, but do not specify how their domain-specific composite scores are formed or combined. The composite calculation, weighting, and treatment of scores across domains are not reported in the registry record.
Assessing cognition at baseline and follow-up can describe change in measured performance over time. A mean conveys the group’s average score or change, while a standard deviation describes spread among individual measurements. Those summaries do not show the full distribution or explain why individuals differ. In a single-group study, a measured change is not a direct estimate of a between-group treatment effect. The registry record does not report the primary outcome values, the calculated change, its standard deviation, or a confidence interval.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record describes a completed, single-group study of Magtein in people with mild to moderate dementia, with enrollment listed as 17. The primary outcome is change from baseline in cognitive function, with assessment at baseline and 6 months. The record’s intervention description specifies a 60-day dosing schedule. These design details define what the study set out to examine, but they are not evidence about the size or direction of the outcome.
No numerical primary outcome results or analysis are reported in the registry record. The primary endpoint’s mean and standard deviation are identified as the intended summary, but their values are absent. There is therefore no reported estimate of average cognitive change to interpret, and no reported confidence interval with which to assess its precision. The record also does not report an inferential test for the primary endpoint. The available information cannot establish whether observed scores increased, decreased, or remained similar.
Even if a within-group change estimate were available, its interpretation would be limited by the design. With no concurrent comparator, change from baseline would describe what happened in the group over time, not what would have happened to a comparable group without the intervention. General sources of change can include measurement variability, underlying progression or fluctuation, and differences in testing conditions. The registry record does not quantify or separate these influences. A before-and-after observation is therefore not equivalent to a controlled estimate of an intervention effect.
The primary outcome description includes four cognitive instruments with different score ranges. Although the record states that higher scores are better, it does not report how the domain-specific composite scores were constructed, whether each measure contributed equally, or how scores were combined for the primary endpoint. Without those details and outcome values, the clinical and statistical meaning of a possible composite change cannot be evaluated from the registry information.
The registry lists 5 outcome measures but 0 analyses. Secondary outcomes are named as Change From Baseline in CMRgl and RBC Magnesium Chemistry, but numerical results for those outcomes are not reported in the registry record. The record also does not report missing outcome counts, analysis populations, or the handling of incomplete measurements. Those omissions matter because the number and characteristics of participants contributing data can affect how an estimate should be understood.
The appropriate reading is therefore descriptive and bounded: the record identifies a study question, an intervention, a single-group design, and outcome definitions. It does not supply the results needed to estimate cognitive change or its uncertainty, and it cannot support a controlled comparison. No conclusion about benefit, lack of benefit, or causal effect follows from these registry entries alone.
9. Statistical Methods Explained
The registry identifies the primary outcome as a mean of a continuous measure, with standard deviation as the dispersion summary. These are common descriptive statistics, but they answer different questions. A mean describes the center of measured values or changes in the group. A standard deviation describes how dispersed individual values are around that mean. Neither statistic alone shows whether a difference is precisely estimated, whether individual responses are similar, or whether a change is attributable to an intervention.
What would a confidence interval add?
In general, a confidence interval expresses the uncertainty around an estimated quantity under the assumptions of the statistical method used. A relatively narrow interval indicates greater precision than a wide interval, while the interval’s location indicates which values remain compatible with the data and model. It is not a range containing a fixed proportion of individual participant outcomes. No confidence interval for the primary outcome is reported in the registry record, so the precision of any cognitive-change estimate cannot be assessed from the available results.
What does a within-group change estimate?
A change-from-baseline analysis summarizes how scores differ between a participant’s starting assessment and a later assessment, or how such changes average across a group. General statistical practice can use the pairing of repeated measurements to account for their relationship. The registry record does not report the method used to calculate change, whether individual paired observations were analyzed, or the model used. More importantly, a mean change in a single group is not a comparison of change between intervention and control groups. It cannot separate intervention-associated change from time-related change or other influences.
What is not established by the stated outcome summaries?
A standard deviation is not a standard error and does not itself quantify uncertainty in the estimated mean. A standard error concerns the sampling uncertainty of an estimate and depends on the analysis and data structure. A confidence interval is often constructed using an estimate and its standard error, together with a method-specific reference distribution. The registry does not report the values or analysis details needed to examine such calculations for this endpoint. No recalculated estimate can be made from the registry entries.
The endpoint uses several cognitive instruments. The record says that the outcome consists of domain-specific composite scores for ADAS-COG, MMSE, RBANS, and WAIS-IV, but gives no formula for those composites. In general, combining measures requires a defined scale and rule for combining their information. Raw score ranges differ across these instruments, so a composite’s interpretation depends on how each component is represented and weighted. The registry does not say whether scores were standardized, transformed, or combined in another way. It also does not report the component-level results needed to understand whether a composite reflects similar movement across domains or differing patterns.
How should the planning assumptions be read?
The planning assumptions associated with the record describe a two-arm illustration using a two-sided significance level of 0.05, equal allocation, and a normal approximation. The effect to detect is defined as a stated fraction of the observed effect. Such an illustration is a planning exercise, not an observed study result and not observed power. The record’s study design is single-group, so an equal-allocation two-arm illustration does not describe the intervention allocation used in this trial. The registry information does not include the numerical planning outputs or the observed primary effect needed to assess such an illustration.
In general, over-dispersion means that variation in the data is greater than a statistical model assumes. If a model understates variation, standard errors may be too small and intervals may appear more precise than justified. This is a general consideration for analyses whose assumptions may not fit the outcome distribution; the registry record does not report evidence of over-dispersion or identify a model for the primary outcome. No claim that over-dispersion occurred in this study is warranted.
What information would be needed to evaluate the analysis?
Assessment of the statistical analysis would require the outcome values or estimates, the number of observations contributing to each analysis, and the methods used to handle repeated measurements and incomplete data. The registry record does not report an analysis plan, model specification, test statistic, interval estimate, or results for the primary endpoint. The listed count of 0 analyses reinforces that no analysis details are available in the record. These omissions prevent an independent assessment of model fit, uncertainty, or sensitivity to analytic choices.
Statistical significance and clinical importance are also distinct general concepts. A significance test addresses compatibility with a specified null model under its assumptions; it does not establish the size or practical importance of a result. Clinical interpretation requires a meaningful scale, an interpretable effect estimate, and context for judging that estimate. The registry identifies score ranges and the direction of higher scores, but does not report a clinically meaningful threshold or outcome estimate. Thus neither statistical nor clinical importance can be determined from the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 5 outcome measures, including the primary cognitive endpoint and secondary outcomes named as Change From Baseline in CMRgl and RBC Magnesium Chemistry. It reports 0 analyses. The registry record does not report a prespecified multiplicity strategy, such as whether the primary endpoint was tested as a single primary hypothesis or how inference across multiple outcomes would be handled.
In general, examining multiple outcomes can increase the chance of observing an apparently notable result by chance when each is interpreted independently. Methods for addressing multiplicity can control the overall error rate or distinguish confirmatory outcomes from exploratory ones. Those methods depend on the planned hypotheses and analysis, which are not reported in the registry record. No adjustment or unadjusted result can be inferred.
The record does not report missing primary outcome measurements, reasons for missingness, or the analysis population. It also does not describe whether participants were included according to enrollment, treatment received, or availability of outcome data. These are not interchangeable analysis populations: the choice determines which observations contribute and can affect interpretation. No approach to imputation, exclusion, or sensitivity analysis is reported in the registry record.
Repeated cognitive assessments can be incomplete, and general methods make different assumptions about how missing values arise. The registry does not describe a missing-data model or state whether missingness was assessed. Consequently, the completeness of follow-up and the robustness of any outcome estimate cannot be evaluated from the available registry information.
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 |
|---|---|---|---|
| Magtein Adverse Events | 1 | 17 | 5.9% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Magtein Adverse Events | 0 of 17 |
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 |
|---|---|
| Magtein Adverse Events | 0 of 17 |
Most frequent serious adverse event terms
| Event term | Organ system | Magtein Adverse Events |
|---|---|---|
| GI Problem | Gastrointestinal disorders | 1 of 17 |
Serious events with the highest arm-level rate: gi problem (5.9%).
The adverse-event entry lists 17 at risk in the Magtein group and 1 affected by a serious adverse event. It lists 17 at risk for other adverse events and 0 affected. Deaths are listed as 0. The registry also names GI Problem as the top serious term, with 5.9% shown.
These are the reported counts and term, not a comparison with an untreated or placebo group. In a single-group study, the counts cannot establish whether an event was caused by the supplement or would also have occurred without it. The registry information does not report event narratives, timing, duration, severity beyond the serious-event classification, or the investigators’ assessment of relatedness. The GI Problem entry should therefore be read as a reported serious-event term, not as evidence of causation.
Counts from a small study can be imprecise descriptions of safety experience and may not capture uncommon events. The registry record does not provide further detail on the definition or collection procedures for adverse events. The absence of listed deaths or other adverse events in this entry does not establish that there was no risk, and the serious-event count alone does not establish a treatment-related safety effect.
12. What the Result Does, and Does Not, Mean
The study addresses whether Magnesium L-Threonate is associated with change in cognitive function among people with mild to moderate dementia. The record describes Magtein as the intervention and identifies neurocognitive measures intended to capture change from baseline to 6 months. This defines the research question, but the registry record does not report numerical primary outcome results.
Because the design is single-group and has no reported comparator, a change over time would not by itself show that the intervention caused the change. General influences on repeated cognitive scores can include variation in measurement, fluctuation over time, changes in testing circumstances, and the course of the underlying condition. The registry information does not provide a design or analysis that separates these possibilities.
The record also does not report the analysis details needed to judge the precision of an estimated change. No mean change, standard deviation value, confidence interval, or primary-outcome analysis is reported in the registry record. The endpoint description identifies the instruments and states that higher scores are better, but does not explain the composite scoring procedure. Accordingly, neither the size nor the meaning of a numerical cognitive effect can be evaluated from this record.
The adverse-event entry describes reported counts in the Magtein group, including 1 serious adverse event and 0 deaths. Without a comparison group or additional event details, these figures describe the registry entry rather than a causal safety effect. The listed serious term does not establish that the supplement caused the event.
The record’s completed status should not be confused with a complete report of analyzed results. It records a study design, intervention, outcome definitions, and limited safety information, but does not supply an interpretable estimate of cognitive change. The findings described in the registry therefore do not establish that the intervention improves cognition, nor do they establish that it has no effect. They also cannot support a comparison with another treatment or with no treatment.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of the distinction between a research question and an estimate that can answer it. The registry describes a question about cognitive change after supplementation, but lists a single-group design without masking or a comparator. That structure can describe change within the enrolled group, yet it cannot independently estimate how that change differs from what would have occurred under another condition.
The cognitive endpoint also raises measurement questions that matter for interpretation. It draws on ADAS-COG, MMSE, RBANS, and WAIS-IV, which have different score ranges. The record calls the outcome domain-specific composite scores but does not report the method for forming them. A clearly defined scoring rule is important because the resulting estimate depends on how component scores are represented and combined.
Registry completeness is another statistical issue. The record lists 5 outcome measures and 0 analyses, but does not include primary outcome estimates, uncertainty intervals, missing-data handling, or a multiplicity plan. Without these, readers cannot assess precision, the effect of incomplete observations, or how multiple outcomes were treated. A completed study status does not replace those analytic details.
The safety entry similarly illustrates the limits of descriptive counts without a comparison group or event-level context. Counts can document what the registry reports, but do not establish causation or the frequency that would be expected under another condition. The study is therefore useful for examining how design, outcome construction, analysis reporting, and safety context shape the conclusions that can be drawn from a clinical trial 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 is the absence of reported numerical results for the primary cognitive outcome. The registry record identifies mean and standard deviation as the intended summaries, but does not report their values, an estimate of change, or an interval expressing uncertainty. It also lists 0 analyses. The statistical size and precision of any change are therefore not assessable.
The single-group design has no concurrent comparator, and masking is listed as NONE. Without a control group, change over time cannot be separated from background variation or other influences. The record does not report details about assessment procedures that would allow readers to evaluate possible measurement effects.
The timing information is not fully explained: the intervention description specifies 60 days of dosing, while the primary outcome timeframe is baseline and 6 months. The registry record does not explain the relationship between those schedules or give additional assessment dates. It also does not report adherence or whether participants completed the planned dosing.
The primary outcome’s composite construction is not described beyond the component instruments and the term domain-specific composite scores. The record does not report the calculation, weighting, or component-level results. It also does not report participant characteristics, eligibility details, missing-data handling, analysis populations, or a statistical analysis plan. These omissions limit assessment of generalizability and analytic reliability.
The enrollment is listed as 17, and the safety entry provides limited event counts without a comparison group or detailed event information. Such a record cannot characterize uncommon risks with precision. These limitations are specific to the design and reporting details available in the registry and do not imply that unreported procedures or analyses were or were not performed.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Magnesium L-Threonate for the Enhancement of Learning and Memory in People With Dementia — NCT02210286.
- Registry record last updated 2021-02-02; status last verified 2021-01.
- Results first posted 2021-02-02.
- 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, single-group study of Magtein, a dietary supplement, in people with mild to moderate dementia. Enrollment is listed as 17, masking as NONE, and allocation as NA. The intervention description specifies 1800 mg/day orally for 60 days. The primary outcome is change from baseline in cognitive function, using domain-specific composite scores from ADAS-COG, MMSE, RBANS, and WAIS-IV, with a stated timeframe of baseline and 6 months.
The registry lists 5 outcome measures and 0 analyses. Numerical primary outcome results, an analysis plan, and missing-data methods are not reported in the registry record. Safety information lists 1 serious adverse event among 17 at risk in the Magtein group, 0 other adverse events among 17 at risk, and 0 deaths; GI Problem is listed as the top serious term at 5.9%. The single-group design and limited result reporting preclude a controlled estimate of intervention effect.