Comparison · NCT03444870-b8831350
Global - OLE Period: Gantenerumab (DBT) to Gantenerumab vs Global - OLE Period: Placebo (DBT) to Gantenerumab: OLE Period: Number of Participants With at Least One ARIA-E MRI Finding
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. Global - OLE Period: Gantenerumab (DBT) to Gantenerumab vs Global - OLE Period: Placebo (DBT) to Gantenerumab: OLE Period: Number of Participants With at Least One ARIA-E MRI Finding. Trial comparisons, record NCT03444870-b8831350. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03444870-b8831350
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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 | 0.1 | 0.0279 | 0.301 | wilson | |
| Risk in group 2 | 0.333 | 0.121 | 0.646 | wilson | |
| Risk difference, group 1 minus group 2 | -0.233 | -0.554 | 0.0594 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.3 | 0.0601 | 1.5 | log | |
| Odds ratio, group 1 over group 2 | 0.222 | 0.0297 | 1.66 | log | |
| Number needed to treat, for one fewer participant with the outcome on Global - OLE Period: Gantenerumab (DBT) to Gantenerumab than on Global - OLE Period: Placebo (DBT) to Gantenerumab | 4.29 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Global - OLE Period: Gantenerumab (DBT) to Gantenerumab | Participants who received gantenerumab in the DBT period continued receiving gantenerumab, SC injections, 510 mg, Q2W up to Week 34 of the OLE period. | 2 | 20 | OG001 |
| Group 2 | Global - OLE Period: Placebo (DBT) to Gantenerumab | Participants who received gantenerumab matching placebo in the DBT period received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W up to Week 34 of the OLE period. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo. | 3 | 9 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- OLE Period: Number of Participants With at Least One ARIA-E MRI Finding
- Description
ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. In ARIA-E, (E for oedema or effusion), oedema can be seen in different areas of the brain on MRI, representing fluid leakage into the brain parenchyma or sulcal spaces.
- Time frame
- From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 68 weeks)
- Population
SEMRI analysis set included all participants in SE analysis set who had at least one post-baseline safety MRI scan. In DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in gantenerumab arm for SE analysis set, of which 1 participant entered OLE period. Overall number analyzed is the number of participants with data available for analysis. Overall number analyzed is the number of participants with data available for analysis.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
- NCT number
- NCT03444870
- Phases
- PHASE3
- Conditions
- Alzheimer Disease
- Interventions
- Gantenerumab, Placebo
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2024-01-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03444870?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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