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 The Efficacy of Galantamine Treatment on Attention in Patients With Alzheimer's Disease (NCT01054976), a na phase 4 study. The primary outcome is Change From Baseline in Simple Reaction Time.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01054976 |
| Phase | Phase 4 |
| Condition | Alzheimer's Disease |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 99 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Janssen Korea, Ltd., Korea |
| Results posted | Yes |
2. Clinical Question
Population
Patients with Alzheimer’s dementia; the primary outcome population is identified as the per-protocol analysis set.
Intervention
Galantamine treatment.
Comparator
No separate control group is described. The primary outcome is framed as change from baseline.
Primary question
How did simple reaction time change from baseline to Week 12 during galantamine treatment?
The study’s stated purpose was to examine whether galantamine administration was associated with improvement in attention, and whether it was more effective for patients with serious attention disturbance. Attention testing was planned at baseline, Week 4 and Week 12. The primary outcome, however, is specified as change from baseline in simple reaction time at baseline and Week 12. The registry record does not report a numerical result for that outcome or a result for the attention-disturbance subgroup question.
Simple reaction time is a computerized task in which a participant responds when the screen changes from black to white. The record describes a total of 70 trials over six minutes. The clinical question is therefore about performance on a particular attention task, not a direct measure of every aspect of attention or everyday functioning. Other listed outcomes include cognitive performance and measures of disability and instrumental activities of daily living. The presence of those outcomes does not establish what changes occurred or whether they supported the primary outcome.
Because the study is recorded as single-group and allocation is listed as NA, the primary question is not a randomized comparison of galantamine with a concurrent control treatment. A change from baseline can describe participants’ measurements over time, but by itself it cannot distinguish treatment-related change from other explanations for change during follow-up.
3. Trial Design
The registry identifies this as a Phase 4, single-group study with allocation listed as NA and masking listed as none. It records an enrollment of 99 and a completed status. The study start is listed as 2006-10, with primary completion listed as 2009-02. Janssen Korea, Ltd., Korea is named as the sponsor. These design features describe the registry entry; they do not establish details that the entry does not report.
Galantamine is the listed intervention. The brief summary describes administering it to patients with Alzheimer’s dementia and assessing attention at baseline, Week 4 and Week 12. The primary outcome is change from baseline in simple reaction time, measured in seconds, with the stated timeframe of baseline and Week 12. The primary outcome population is the per-protocol analysis set. The arm description contains no further treatment details, so dose, schedule, treatment duration beyond the assessment schedule, and adherence procedures are not reported in the registry record.
A single-group design can document how measurements in the enrolled group vary over time. It does not create a like-for-like control comparison. Without a concurrent comparison group, observed change may reflect factors other than the intervention, including the passage of time, repeated testing, changes in participant status, or other events during follow-up. These are general considerations for interpreting single-group studies, not findings about this study.
The registry lists three secondary outcomes: change from baseline in the Alzheimer’s Disease Assessment Scale - Cognitive Subscale, the Korean Version of Disability Assessment for Demential Scale, and Seoul-Instrumental Activities of Daily Livings. It records five outcome measures in total and zero analyses. The registry record does not report a detailed protocol, a sample-size justification, an interim-analysis plan, or the methods used to conduct the outcome analyses.
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 | Galantamine |
|---|---|
| STARTED | 92 |
| COMPLETED | 57 |
| NOT COMPLETED | 35 |
Reasons for not completing this period:
| Reason | Galantamine |
|---|---|
| Adverse Event | 16 |
| Uncooperative participations to study | 7 |
| Withdrawal by Subject | 4 |
| Other | 8 |
Analysis population for the primary outcome, as defined in the registry: Per-protocol (PP) analysis set.
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 | Galantamine |
|---|---|---|
| Participants analysed | 92 | |
| Age Continuous | Years | 73.24 (SD 7.969) |
| Sex: Female, Male: Female | Participants | 70 |
| Sex: Female, Male: Male | Participants | 22 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Simple Reaction Time, measured over Baseline, Week 12.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | seconds |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in simple reaction time, expressed in seconds. The test evaluates the time taken to respond when a computer screen changes from black to white. The registry describes 70 trials over six minutes. The recorded assessment times for the primary endpoint are baseline and Week 12; the broader study summary also describes attention testing at Week 4.
Reaction time is a continuous measure: each participant’s result can take a range of numerical values rather than falling into a small set of categories. Summarizing such measurements with a mean describes the group’s average response time. A standard deviation describes how spread out individual measurements are around that mean. Those summaries can help characterize both the group’s typical measured performance and the variability among participants, but neither alone describes every participant’s experience.
In general, a reaction-time task is used because it provides a standardized way to measure speed of response to a defined stimulus. A shorter time would ordinarily mean a faster response on the task, but interpretation also depends on how the endpoint is calculated, the quality of testing, and whether changes are large enough to be meaningful. The registry record identifies a mean and standard deviation as the endpoint summary, but does not report the numerical mean, standard deviation, or change.
The task measures performance on this specific computerized test. It should not be treated as a complete measure of attention, cognition, or daily functioning. The registry lists separate cognitive and functional outcomes, but their numerical results are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record identifies the primary outcome and its planned assessment times, but it does not report the numerical change in simple reaction time, its standard deviation, a confidence interval, or a statistical test result. Consequently, the amount and precision of any observed change cannot be evaluated from the registry record. The record also does not provide numerical findings for the listed secondary outcomes.
This absence matters for interpretation. Naming an endpoint and describing how it was measured does not reveal whether the group’s average result changed, how variable participant results were, or how compatible the observed data were with different possible changes. A confidence interval, in general, conveys the range of effect values that are reasonably compatible with the data and the analysis assumptions. No such interval is reported for the primary endpoint in this registry entry.
The study’s single-group structure also limits what a change from baseline can establish. In general, before-and-after measurements can describe change over time among participants, but they do not by themselves isolate the effect of treatment. Repeated exposure to a task, changes in health or circumstances, and other time-related influences can also affect follow-up measurements. A concurrent control group can help address some of these explanations; no such group is described in this record.
The primary outcome is assigned to the per-protocol analysis set. The registry does not explain how that set was defined, how many participants contributed primary outcome data, or how missing measurements were handled. The enrollment of 99 should therefore not be treated as the number included in the primary analysis. The adverse-event record separately lists 92 participants at risk for its event summaries, but it does not explain the relationship between that safety population and the analysis population.
The stated aim also includes whether galantamine was more effective for patients with serious disturbance of attention. The registry record does not report a subgroup definition, subgroup estimate, or analysis result for that question. The sample-size assumptions describe planning illustrations based on an observed effect and hypothetical two-arm designs, with equal allocation and a normal approximation. Because this trial is recorded as single-group and no primary outcome effect estimate is reported in the registry entry, those illustrations should not be read as evidence of observed power or as a randomized comparison.
Overall, the registry describes the question and measurement approach, but the numerical efficacy results needed to judge the size and precision of change are not reported in the registry record. No conclusion about treatment effect can be drawn from the outcome description alone.
9. Statistical Methods Explained
The primary outcome is continuous and is summarized using a mean and standard deviation. In general, a mean is the arithmetic average of observed values and gives a concise description of the group’s central result. A standard deviation describes the extent to which values vary around that mean. Together they can communicate both the average response time and participant-to-participant variability. They do not show the full distribution, reveal whether the result is influenced by unusual values, or indicate the precision of an estimated change without additional information.
The outcome is defined as change from baseline. In general, a change score compares a participant’s later measurement with that participant’s starting measurement, then the group summary describes those individual changes. This differs from simply reporting a follow-up mean: the two approaches answer different descriptive questions and can have different statistical properties. The registry names change from baseline as the endpoint but does not report the precise calculation, the numerical result, or the analysis model used.
A confidence interval is a general statistical tool for expressing uncertainty around an estimate. It gives a range of values compatible with the observed data under the chosen method and its assumptions. A narrower interval generally indicates greater precision, while a wider interval indicates more uncertainty. The registry record does not report a confidence interval for simple reaction time, so the precision of the primary estimate cannot be assessed. A p-value, if reported, would address compatibility with a specified null model; it would not on its own measure the size or clinical importance of an effect. No primary-outcome p-value is reported in the registry record.
The design is single-group, with no masking and allocation listed as NA. In general, masking can reduce the influence of knowledge about treatment assignment on participant behavior, outcome assessment, or other study processes. No masking is recorded. A single-group design has no concurrent control arm against which to compare the observed course. This means that a change over time cannot automatically be attributed to galantamine. This is a general limitation of the design, not a claim about the cause of any unreported result.
Repeated measurements can provide a view of how performance changes over time. The summary describes attention tests at baseline, Week 4 and Week 12, while the primary endpoint timeframe names baseline and Week 12. The registry does not state how the Week 4 measurement was used in the primary analysis, whether repeated measurements were modeled jointly, or what assumptions were made about within-participant correlations. Those analysis details are not reported in the registry record.
The per-protocol analysis set is named for the primary outcome. In general, a per-protocol analysis includes participants who meet criteria for adherence or study completion, but the exact definition depends on the study. The registry does not define the set, report its size, or state which participants were excluded. Therefore, it is not possible to determine from this entry how the analyzed participants relate to the enrolled group or whether exclusions could affect interpretation.
The record lists zero analyses. That entry does not supply an analysis method or numerical result. The statistical plan, including any model specification, treatment of outliers, baseline adjustment, assumption checks, and handling of multiple outcomes, is not reported in the registry record. These details matter because statistical methods can affect both estimates and their uncertainty.
Over-dispersion is a general concern mainly for count outcomes when observed variability exceeds what a chosen count model expects. The primary endpoint is continuous reaction time, not a count. For a continuous measure, the relevant distributional and variance assumptions depend on the analysis method; the registry does not identify that method or report diagnostic checks. It would therefore be inappropriate to claim that a particular assumption was met or violated.
The sample-size assumptions describe a planning illustration using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is stated as a fraction of the observed effect. The record also notes that time-to-event illustrations use total events, while other illustrations use participants per arm. These are general planning calculations, not observed trial outcomes or observed power. They do not alter the single-group design recorded for this study, and the registry does not report that these assumptions were used to plan the trial.
Multiplicity is a general issue when multiple outcomes or analyses are considered: the more questions examined, the greater the chance that an apparently unusual finding may arise by chance if no adjustment or prespecified hierarchy is used. The record lists five outcome measures, but does not report a multiplicity strategy or analysis hierarchy. It is therefore not possible to determine how the investigators intended to manage the several outcome questions.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures: the primary simple reaction-time endpoint and secondary measures of cognition, disability, and instrumental activities of daily living. It records zero analyses. A prespecified hierarchy or adjustment for considering several outcomes is not reported in the registry record. In general, multiplicity methods are used to control the chance of false-positive conclusions across multiple statistical tests. Without a reported approach, the relationship among the outcome tests and any adjustment cannot be assessed.
The primary outcome population is identified as the per-protocol analysis set, but the registry does not define that set or report its size. It also does not report the number with usable baseline and follow-up measurements, reasons for missing data, or the method used to handle missing observations. Such information is important because analyses based only on participants with complete measurements can be affected if missingness is related to participant status or outcome values. This is a general concern, not a claim that missing data biased this study.
The entry does not state whether all enrolled participants were included in any analysis, whether a separate safety population was defined, or how the safety denominator relates to the primary outcome population. No interim-analysis plan or stopping rule is reported in the registry record. The record’s listing of zero analyses does not resolve these omissions; numerical results and the methods used to obtain them are also not reported.
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 |
|---|---|---|---|
| Galantamine | 8 | 92 | 8.7% |
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 |
|---|---|
| Galantamine | 41 of 92 |
Most frequent serious adverse event terms
| Event term | Organ system | Galantamine |
|---|---|---|
| Fall | Injury, poisoning and procedural complications | 2 of 92 |
| Fracture | Injury, poisoning and procedural complications | 2 of 92 |
| Asthenia | Musculoskeletal and connective tissue disorders | 1 of 92 |
| Nausea | Gastrointestinal disorders | 1 of 92 |
| Headache | General disorders | 1 of 92 |
| Delirium | Psychiatric disorders | 1 of 92 |
| Brain stem infarction | Nervous system disorders | 1 of 92 |
| Hyperglycemia | Metabolism and nutrition disorders | 1 of 92 |
| Neuromyopathy | Nervous system disorders | 1 of 92 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Galantamine |
|---|---|---|
| Nausea | Gastrointestinal disorders | 15 of 92 |
| Dizziness/vertigo | Nervous system disorders | 7 of 92 |
| Anorexia | Nervous system disorders | 6 of 92 |
| Headache | General disorders | 5 of 92 |
| Vomiting | Gastrointestinal disorders | 5 of 92 |
| Diarrhea | Gastrointestinal disorders | 4 of 92 |
| Chest discomfort | Cardiac disorders | 2 of 92 |
| Weight loss | Metabolism and nutrition disorders | 2 of 92 |
| Insomnia | General disorders | 2 of 92 |
| Poor appetite | Metabolism and nutrition disorders | 2 of 92 |
Serious events with the highest arm-level rate: fall (2.2%), fracture (2.2%), asthenia (1.1%), nausea (1.1%), headache (1.1%).
The adverse-event record lists 92 participants at risk in the Galantamine group for both serious events and other events. It records 8 participants affected by serious adverse events and 41 affected by other adverse events. These are counts of participants, not a complete description of event severity, timing, duration, or causal attribution. The registry record does not explain whether participants could contribute to more than one event category or provide additional detail about event collection.
The listed serious adverse-event terms and percentages are Fall, 2.2%; Fracture, 2.2%; Asthenia, 1.1%; Nausea, 1.1%; Headache, 1.1%; and Delirium, 1.1%. These entries describe the registry’s reported terms and percentages; they do not establish that galantamine caused the events. The registry does not report deaths in this safety record.
In general, safety counts should be read with attention to the population at risk, how events were defined and collected, and whether a comparison group is available. This study is recorded as single-group, so the listed counts do not provide a like-for-like control comparison. The record does not report enough detail to assess comparative risk or attribute events to treatment.
12. What the Result Does, and Does Not, Mean
The registry record describes a study that examined attention during galantamine treatment in patients with Alzheimer’s dementia. It specifies a computerized simple reaction-time task, the primary assessment timeframe, and a per-protocol analysis population. It also lists cognitive and functional secondary outcomes and provides safety counts for the Galantamine group. These details show what the record set out to measure and which safety summaries it contains.
The primary numerical outcome is not reported in the registry record. There is no reported mean change, standard deviation, confidence interval, or statistical test result for simple reaction time. Numerical results for the listed secondary outcomes are also not reported. Without these estimates, the magnitude, direction, and precision of any outcome change cannot be described. The study’s aim is not itself evidence that the aim was achieved.
Even if a before-and-after change were available, the single-group design would limit causal interpretation. In general, change during follow-up may reflect the intervention, but it may also reflect other factors that change over time or repeated testing. The record does not include a concurrent control group to help distinguish those explanations. No claim that galantamine caused a change, or that it did not cause a change, can be supported by the information in this record.
The safety counts report participants with serious and other adverse events, along with selected serious-event terms and percentages. They do not provide a randomized comparison or establish causation. The record also does not report the primary analysis sample size, missing-data handling, or detailed analysis methods. Those gaps further limit how precisely the findings can be evaluated.
Accordingly, the appropriate reading is descriptive: the registry identifies the study’s question, measures, design, and reported safety counts, but does not report the numerical efficacy results needed to characterize the primary outcome. No medical advice or treatment conclusion follows from these registry entries.
13. Why This Trial Matters Statistically
This study illustrates why statistical interpretation starts with the design and the estimand, not only with the name of an endpoint. The record describes a single-group study and a change-from-baseline outcome. That setup can describe how measured reaction time changes among participants over time, but it does not provide a randomized contrast with a concurrent control group. The distinction matters because a time trend is not automatically a treatment effect.
It also illustrates the difference between specifying an outcome and reporting its result. The registry gives a clear task description and identifies mean and standard deviation as summaries, yet the numerical primary outcome is not reported in the registry record. Without an estimate and a measure of uncertainty, statistical readers cannot judge either the apparent size of change or its precision. A well-described measurement does not substitute for a reported result.
The named per-protocol population raises another practical issue. Analysis populations affect the group to which a result applies, and a per-protocol label is not enough to reconstruct who contributed data. The registry does not define that population or state how missing observations were addressed. These omissions make it difficult to assess selection and follow-up issues.
Finally, the sample-size assumptions are explicitly planning illustrations involving hypothetical two-arm designs, while the study itself is recorded as single-group. This is a useful distinction in statistical communication: planning scenarios should not be mistaken for the trial’s actual design, a completed analysis, or evidence of observed power. Together, these features show why design, analysis population, outcome reporting, and uncertainty must be considered alongside the clinical question.
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.
Several limitations specific to this registry entry constrain interpretation. The study has a single-group design, allocation is listed as NA, and masking is listed as none. There is no separate control group described for comparison with galantamine. A before-and-after result, even if reported, would therefore have limited ability to separate treatment-associated change from other changes during the study period.
The registry identifies the per-protocol analysis set for the primary endpoint but does not define it or report its size. Although enrollment is recorded as 99, the number included in the primary analysis is not reported in the registry record. The relationship between that analysis population and the 92 participants listed at risk in the adverse-event record is also not explained.
The primary endpoint’s numerical result is not reported, nor are numerical findings for the secondary outcomes. The analysis methods, missing-data procedures, multiplicity approach, and interim-analysis plan are not reported in the registry record. The attention-disturbance subgroup question appears in the study summary, but a subgroup definition and result are not reported. The record also does not give treatment dose, schedule, or adherence details.
Finally, the registry’s planning assumptions describe hypothetical two-arm illustrations and do not establish the study’s original design justification. These gaps mean that neither efficacy estimates nor their precision can be evaluated from the registry entry alone.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The Efficacy of Galantamine Treatment on Attention in Patients With Alzheimer's Disease — NCT01054976.
- Registry record last updated 2012-12-24; status last verified 2012-11.
- Results first posted 2012-12-24.
- 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
This completed Phase 4 study is recorded as a single-group evaluation of galantamine in patients with Alzheimer’s dementia. The registry lists enrollment of 99, allocation as NA, and masking as none. Attention testing is described at baseline, Week 4 and Week 12. The primary endpoint is change from baseline in simple reaction time, measured in seconds and summarized by a mean and standard deviation for the per-protocol analysis set.
The record lists three secondary outcomes concerning cognition, disability, and instrumental activities of daily living. It also reports serious and other adverse-event counts for 92 participants at risk in the Galantamine group. The numerical primary and secondary outcome results, detailed analysis methods, and missing-data procedures are not reported in the registry record. The single-group design does not provide a concurrent control comparison.