Comparison · NCT02079246-sae
Idalopirdine 60 mg vs Idalopirdine 60 mg + Memantine: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Idalopirdine 60 mg vs Idalopirdine 60 mg + Memantine: serious adverse events. Trial comparisons, record NCT02079246-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02079246-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0622 | 0.051 | 0.0758 | wilson | |
| Risk in group 2 | 0.0198 | 0.00545 | 0.0693 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0424 | -0.00837 | 0.0622 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.14 | 0.786 | 12.6 | log | |
| Odds ratio, group 1 over group 2 | 3.29 | 0.797 | 13.5 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Idalopirdine 60 mg than on Idalopirdine 60 mg + Memantine | 23.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Idalopirdine 60 mg | Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. | 91 | 1,462 | EG000 |
| Group 2 | Idalopirdine 60 mg + Memantine | Idalopirdine 60 mg as adjunct to 10 mg donepezil and memantine (patient's individualised maintenance dose, either immediate-release (IR) 20 mg/day (recommended target dose) or extended release (XR) 28 mg/day (recommended target dose). Memantine was administered to approximately 100 patients included in the OLEX-MEM. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. The dose of memantine could be changed at any time throughout the study. | 2 | 101 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Source ClinicalTrials.gov
Trial
- Title
- Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease
- NCT number
- NCT02079246
- Phases
- PHASE3
- Conditions
- Alzheimer's Disease
- Interventions
- Idalopirdine 60 mg
- Lead sponsor
- H. Lundbeck A/S
- Results first posted
- 2018-08-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02079246?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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