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 Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia (NCT01059877), a randomized na study. The primary outcome is Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) Delayed Word Recall..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01059877 |
| Phase | NA |
| Condition | Dementia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 11 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Quietmind Foundation |
| Results posted | Yes |
2. Clinical Question
Population
People with dementia. The official title describes early and mid-stage dementia, while the registry condition is listed as dementia.
Intervention
Transcranial 1072nm infrared photobiomodulation, described as infrared light stimulation for dementia.
Comparator
A placebo device simulating transcranial photobiomodulation.
Primary question
How did the ADAS-Cog Delayed Word Recall score change from baseline after the treatment period in each group, and what does the registry record establish about a difference between groups?
The trial was randomized and placebo-controlled, with a parallel-group design. Its stated purpose was to assess effects on behavioral and cognitive symptoms associated with early and mid-stage dementia. The posted primary endpoint is a cognitive measure: the change in delayed word recall from pretreatment measurement to measurement after the intervention period.
The registry reports a mean change of 3.17 units in the treatment group and 3.0 units in the placebo group. These are separate group summaries, not a reported estimate of the treatment-versus-placebo difference. The registry record does not report a statistical analysis comparing the groups, a confidence interval, or a p-value. Accordingly, the numerical summaries describe the posted outcome but do not by themselves establish whether the groups differed beyond what might occur through sampling variability.
3. Trial Design
The study is registered as a randomized, placebo-controlled, parallel-group clinical trial of 1072nm infrared photobiomodulation for dementia. The intervention group received transcranial 1072nm infrared light stimulation, and the comparator group received a placebo device designed to simulate transcranial photobiomodulation. The registry lists the masking as triple. Its brief summary describes a double-blind, placebo-controlled approach. The record therefore contains both descriptions, without further explanation of their relationship.
Enrollment is listed as 11. The registry gives a start date of 2010-01, primary completion of 2012-02, and a completed status. The primary outcome summaries are based on 6 participants in the treatment group and 3 in the placebo group. The reason that the outcome summaries do not account for the full registered enrollment is not reported in the registry record. The record does not state whether this reflects missing outcome measurements, exclusions, or another reason, so none of those explanations can be assumed.
The primary outcome was assessed after the total intervention period of 28 days, with baseline and post-treatment measurements taken within 72 hours of the first and final treatment days, respectively. The registry reports one outcome measure and no analyses. It does not report the trial's sample-size justification, details of random sequence generation or allocation concealment, or a fuller statistical analysis plan. These absent details limit interpretation of how the study was designed to quantify uncertainty and how the posted summaries were intended to be analyzed.
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 | Treatment Group | Placebo Group |
|---|---|---|
| STARTED | 6 | 5 |
| COMPLETED | 6 | 3 |
| NOT COMPLETED | 0 | 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 | Treatment Group | Placebo Group | Total |
|---|---|---|---|---|
| Participants analysed | 6 | 3 | 9 | |
| Age, Continuous | years | 80 (74 to 89) | 84 (76 to 96) | 81 (74 to 96) |
| Sex: Female, Male: Female | Participants | 2 | 2 | 4 |
| Sex: Female, Male: Male | Participants | 4 | 1 | 5 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: United States | Participants | 6 | 3 | 9 |
| Delayed word recall | units on a scale | 0.50 (0 to 1) | 1.33 (0 to 4) | 0.798 (0 to 4) |
| Trail making A | errors at task | 0.83 (0 to 5) | 9.00 (3 to 14) | 3.56 (0 to 14) |
6. Primary Endpoint
The registry lists the primary outcome as Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) Delayed Word Recall., measured over Post-tx (total intervention period = 28 days) scores to be compared to baseline scores..
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | units on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is change in the ADAS-Cog Delayed Word Recall score. Delayed Word Recall is a subscale of the Alzheimer's Disease Assessment Scale-Cognitive, which measures cognitive impairment. The registry states that higher scores indicate greater impairment and that the subscale ranges from 0 to 10. The reported outcome is calculated by subtracting the pretest score from the post-test score, so it represents change over the intervention period rather than the post-treatment score alone.
The timing is specified as measurement within 72 hours of the first treatment day for baseline and within 72 hours after the 28th treatment day for the follow-up measure. The endpoint is useful for describing whether delayed word recall scores shifted over that period. Because change is defined as post-test minus pretest, a positive change is in the direction of a higher score, which the registry associates with greater impairment. This interpretation describes the scale's direction; it does not by itself establish the cause of a change or show whether a difference between study groups is statistically reliable.
The treatment group has a reported mean change of 3.17 units, with a full range from 2.0 to 4.0. The placebo group has a reported mean change of 3.0 units, with a full range from 3.0 to 3.0. The registry does not report a confidence interval or a formal between-group analysis for this endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted outcome is a change score, calculated as post-test minus pretest. The mean change is 3.17 units for the 6 participants represented in the treatment-group outcome summary and 3.0 units for the 3 participants represented in the placebo-group summary. The treatment-group full range is 2.0 to 4.0, while the placebo-group full range is 3.0 to 3.0. Since higher ADAS-Cog Delayed Word Recall scores indicate greater impairment, a positive change is in the direction of a higher score. The group summaries describe the observed changes; they do not show why the scores changed.
The registry does not report an estimated treatment-versus-placebo effect, a confidence interval, a p-value, or any posted analysis. It lists zero analyses. The two group means should therefore not be treated as a completed inferential comparison. Without an analysis that accounts for the individual outcome data and the chosen statistical model, the posted summaries do not indicate how much uncertainty surrounds a possible difference between groups.
The ranges offer limited information about spread. The treatment group has a range from 2.0 to 4.0, and the placebo group has a range from 3.0 to 3.0. A range reports only the lowest and highest recorded values; it does not describe the distribution of scores or provide the standard error of a group mean. In particular, a range with identical endpoints in the placebo group does not establish that the underlying population has no variability. The number of participants represented is small, and the range reflects only the values included in that group summary.
The registry lists enrollment of 11, whereas the endpoint summaries list 6 participants in the treatment group and 3 in the placebo group. The record does not explain why these outcome counts differ from enrollment. That leaves uncertainty about outcome availability and the population represented in the reported summaries. It also prevents a reader from determining from the registry alone whether the analysis followed an intention-to-treat approach or another analysis population.
These results are best read as descriptive endpoint summaries from a completed trial record, not as a quantified estimate of comparative efficacy. The registry information does not establish the precision of a treatment effect or permit a reliable conclusion about a between-group difference. Further detail on analysis methods, missing outcomes, and participant disposition is not reported in the registry record.
9. Statistical Methods Explained
Randomization is intended to make treatment assignment independent of participants' characteristics, on average, so that a comparison between groups can support a causal interpretation. In a small trial, however, randomization cannot guarantee that the groups are similar on every relevant characteristic. The registry identifies the study as randomized, but the method used to generate the random sequence and the method used to conceal allocation are not reported in the registry record. Those details matter because predictable assignments or departures from the intended process can compromise the benefits of randomization.
What does the reported masking mean?
Masking is used to reduce the influence of treatment knowledge on participant experience, outcome assessment, or other trial procedures. The registry lists triple masking, while its brief summary calls the approach double-blind. The record does not explain which people were masked or why the descriptions differ. Since the primary outcome is a cognitive assessment, knowledge of assignment could potentially influence assessment or participant responses; masking can help limit such influences when implemented appropriately. The record does not provide enough detail to judge how masking was operationalized.
What can group means and ranges tell us?
A mean gives a concise description of the average observed change among the participants included in a group summary. The posted means are 3.17 units for treatment and 3.0 units for placebo. A range gives the minimum and maximum values, but not the shape of the distribution, the amount of variation among most participants, or the precision of the mean. The reported full ranges are 2.0 to 4.0 and 3.0 to 3.0, respectively. The record does not include a standard deviation or another dispersion estimate, and it does not provide individual participant values.
For a comparison between randomized groups, an analysis would ordinarily estimate the contrast between groups and quantify uncertainty around that estimate. A confidence interval is a general statistical tool for expressing the range of effect values compatible with the data and a specified method. A narrow interval indicates greater precision than a wide interval, although the interval's interpretation depends on assumptions and the analysis used. No confidence interval is reported for this endpoint. A p-value, when reported, addresses compatibility of data with a specified null model; it is not a measure of effect size or clinical importance. No p-value is reported either.
Why does the analysis model matter?
The outcome is a change score, so an analysis must account for how baseline and post-treatment scores relate and for the design of the comparison. Possible analysis choices can produce different estimates or uncertainty, particularly when sample sizes are small or data are incomplete. The registry record does not report an analysis model, covariate adjustment, assumptions, or a prespecified contrast. It also does not report a formal estimate for the difference in change between treatment and placebo. Therefore, the individual group summaries cannot be converted into a definitive inferential conclusion from the information in the record.
In general, over-dispersion means that observed variability is greater than a statistical model assumes. When that occurs, model-based standard errors can be too small if the extra variation is ignored, resulting in intervals that appear more precise than warranted. The posted endpoint information does not provide a distribution or a fitted model from which over-dispersion can be assessed. This is a general consideration, not a finding about this trial.
How should planning calculations be read?
Any sample-size planning illustration based on an observed effect is a design calculation, not evidence that a trial had a particular probability of detecting an effect after the fact. The registry's stated planning approach uses a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. Such illustrations depend on their assumptions and on the effect chosen for planning. They do not replace an uncertainty interval or an analysis of the observed trial data, and they should not be described as observed power.
The posted information does not provide sample-size outputs for these assumptions or a justification from the trial's own design. The record also lists no analyses and does not report a recalculated comparison. Consequently, no inferential result or precision measure can be attributed to a statistical model from the information registered. Interpretations should remain descriptive unless additional analysis information is available.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure and no secondary outcomes posted. It reports no analyses. A multiplicity plan—how inference would be controlled when several outcomes, time points, or comparisons are tested—is not reported in the registry record. With one registered outcome measure, multiplicity may be less central than in a record listing many endpoints, but the absence of posted analyses means the intended testing strategy and any selection among analyses cannot be assessed.
The endpoint summaries include 6 treatment participants and 3 placebo participants, compared with registered enrollment of 11. The registry does not report participant flow, reasons for missing endpoint data, or how missing values were handled. It is therefore not possible to determine whether outcomes were unavailable, participants were excluded, or another explanation applies. Missingness can matter because the observed participants may differ from those without recorded outcomes; whether that would alter an estimate depends on the missingness pattern and analysis approach.
The record does not identify an intention-to-treat population, a per-protocol population, or another analysis population. Nor does it report imputation, sensitivity analyses, or rules for handling incomplete data. These omissions make it difficult to judge whether the group summaries represent all randomized participants, all participants with observed measurements, or another set. The registry does not report interim analyses or a multiplicity adjustment, and those details should not be inferred from the absence of posted analyses.
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 |
|---|---|---|---|
| Treatment Group | 0 | 6 | 0.0% |
| Placebo Group | 0 | 3 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Treatment Group | 0 of 6 |
| Placebo Group | 0 of 3 |
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 |
|---|---|
| Treatment Group | 0 of 6 |
| Placebo Group | 0 of 3 |
The registry reports zero serious adverse events among 6 participants at risk in the treatment group and among 3 participants at risk in the placebo group. It also reports zero other adverse events in each group and zero deaths in each group. No serious adverse event terms are listed.
These figures describe events recorded for the participants counted as at risk in the registry. They do not establish that no adverse events occurred outside the reporting definitions or observation period, and they do not show that an event is impossible. A zero count in a small group can coexist with uncertainty about the event rate in a broader population. The record does not provide further detail about safety definitions, collection procedures, exposure time, or the period used for adverse-event surveillance. The figures should therefore be read as registry-reported counts, not as a complete characterization of safety.
The adverse-event denominators match the arm counts listed for the primary outcome, but the record does not explain how those counts relate to total registered enrollment. No inference about relative safety can be drawn from the zero counts alone, especially without a comparative analysis or additional follow-up information.
12. What the Result Does, and Does Not, Mean
The record describes a randomized comparison of transcranial 1072nm infrared photobiomodulation with a simulated placebo device, with delayed word recall change as the primary outcome. It reports mean changes of 3.17 units in the treatment group and 3.0 units in the placebo group. The direction of the scale is stated: higher scores indicate greater impairment. These are descriptive group summaries for the participants included in each reported arm.
The record does not report a direct estimate of the treatment-versus-placebo difference, a confidence interval, or a p-value. It therefore does not quantify the precision of a comparative effect or establish whether the observed group summaries reflect a true difference rather than sampling variability. The posted result does not support a definitive conclusion about treatment effect. It also does not explain why the endpoint summaries include fewer participants than the registered enrollment.
General statistical interpretation distinguishes an observed change from an effect attributable to an intervention. A change within a group can reflect many influences, including natural variation and measurement variability; a randomized comparison is intended to help separate those influences from the intervention effect. That requires an appropriate between-group analysis and sufficient information to evaluate its uncertainty. The registry does not report that analysis.
The endpoint is a cognitive measure over the stated 28-day intervention period, not a comprehensive measure of all behavioral or cognitive symptoms associated with dementia. The record does not report longer-term outcomes or the broader clinical significance of the scale changes. Thus, the findings should be understood within the specific outcome, time frame, and participants represented by the posted summaries. They do not establish effects beyond those limits, nor do they provide medical guidance.
13. Why This Trial Matters Statistically
This trial illustrates why a registry result can contain outcome values without supporting a full statistical conclusion. Randomized assignment is an important design feature, but the interpretation of a randomized comparison also depends on the number of participants with outcomes, the analysis population, the model, and the uncertainty around the estimated contrast. Here, the registry gives group means and ranges but no posted analysis or comparative estimate.
The difference between registered enrollment and participants represented in the outcome summaries is also important. Without a participant flow account or explanation of missing outcome data, a reader cannot tell how the summaries relate to all randomized participants. That is not merely a reporting detail: the relationship between missingness and outcome values can affect how representative the analyzed participants are of the randomized groups.
The record also presents a useful lesson about masking descriptions. It lists triple masking while the brief summary describes a double-blind approach. The trial's masking status is recorded, but the people masked and the implementation details are not explained. Clear descriptions help readers assess how bias might be reduced in an assessment-based outcome.
Finally, the posted endpoint is specific and time-limited: change in delayed word recall around the end of the 28-day treatment period. Its scale direction is reported, while uncertainty around a between-group contrast is not. Statistical interpretation depends not only on a numerical outcome, but also on clear analysis methods, transparent participant accounting, and uncertainty estimates. The registry record makes the descriptive results available, while leaving those inferential elements unreported.
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 primary limitation for statistical interpretation is that the registry reports no analysis of the endpoint. It provides group means and full ranges, but no between-group estimate, confidence interval, or p-value. There is consequently no posted measure of precision for the comparative treatment effect. The reason no analysis is listed is not reported in the registry record.
The outcome summaries include 6 participants in the treatment group and 3 in the placebo group, while enrollment is listed as 11. No participant flow or explanation for this discrepancy in counts is reported. The record does not state whether the outcome summaries include all randomized participants, how incomplete outcomes were handled, or which analysis population was used. These gaps limit assessment of selection and missing-data effects.
The record gives ranges but no standard deviations or individual participant measurements. A range cannot show the distribution of observations or reliably indicate the precision of the mean. The small arm counts also mean that the summaries represent only a limited set of observed participants; the record does not provide an uncertainty measure to help characterize that limitation.
Other design details are not reported in the registry record, including random sequence generation, allocation concealment, the statistical model, any covariate adjustment, and the trial's sample-size justification. The masking descriptions also differ: the registry lists triple masking, while the brief summary says double-blind, with no explanation. The primary outcome covers change over the 28-day intervention period; longer-term outcomes and the broader clinical significance of the score changes are not reported.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia — NCT01059877.
- Registry record last updated 2018-09-27; status last verified 2018-08.
- Results first posted 2018-09-27.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT01059877 is a completed randomized, placebo-controlled, parallel-group study of transcranial 1072nm infrared photobiomodulation for dementia. Enrollment is listed as 11. The registry lists triple masking, while the brief summary describes a double-blind approach.
The primary outcome is change in ADAS-Cog Delayed Word Recall from baseline to post-treatment after a 28-day intervention period. The treatment-group mean change is 3.17 units among 6 participants, with a full range of 2.0 to 4.0. The placebo-group mean change is 3.0 units among 3 participants, with a full range of 3.0 to 3.0. Higher scores indicate greater impairment.
No statistical analyses are posted. A between-group estimate, confidence interval, p-value, and explanation for the difference between enrollment and outcome counts are not reported in the registry record. Serious adverse events, other adverse events, and deaths are recorded as zero in both groups.