Trial · NCT03443973
Outcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | DBT Period: Change From Baseline to Week 116 in Global Outcome, as Measured by CDR-SB | Baseline, Week 116 | ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis. | score on a scale | MEAN |
| PRIMARY | OLE Period: Number of Participants With Adverse Events (AEs) | From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) | OLE safety-evaluable set included all participants randomized during the global enrollment phase who received at least one dose of study drug and who entered the OLE period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | OLE Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) | From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) | OLE safety-evaluable set included all participants randomized during the global enrollment phase who received at least one dose of study drug and who entered the OLE period. Overall number analyzed is the number of participants with data available for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | OLE Period : Number of Participants With Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) Confirmed by MRI | From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) | MRI Safety-evaluable analysis set included all participants in the Safety-evaluable analysis set who had at least one post-baseline safety MRI scan. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | OLE Period: Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI) | From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) | MRI Safety-evaluable analysis set included all participants in the Safety-evaluable analysis set who had at least one post-baseline safety MRI scan. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | OLE Period: Number of Participants With Injection-Site Reactions | From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) | OLE safety-evaluable set included all participants randomized during the global enrollment phase who received at least one dose of study drug and who entered the OLE period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 13 (ADAS-Cog13) Score | Baseline, Week 116 | ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis. | score on a scale | MEAN |
| SECONDARY | DBT Period: Change From Baseline to Week 116 in Alzheimer's Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) Total Score | Baseline, Week 116 | ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis. | score on a scale | MEAN |
| SECONDARY | DBT Period: Change From Baseline to Week 116 in Functional Activities Questionnaire (FAQ) Score | Baseline, Week 116 | ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis. | score on a scale | MEAN |
| SECONDARY | DBT Period: Change From Baseline to Week 116 in Mini-Mental State Examination (MMSE) Total Score | Baseline, Week 116 | ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis. | score on a scale | MEAN |
| SECONDARY | DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 11 (ADAS-Cog11) Score | Baseline, Week 116 | ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis. | score on a scale | MEAN |
| SECONDARY | DBT Period: Change From Baseline to Week 116 in Verbal Fluency Task (VFT) Score | Baseline, Week 116 | ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis. | score on a scale | MEAN |
| SECONDARY | DBT Period: Change From Baseline to Week 116 in the Coding (Digit Symbol Substitution Test [DSST]) Subtest | Baseline, Week 116 | ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis. | score on a scale | MEAN |
| SECONDARY | DBT Period: Change From Baseline to Week 116 in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL) Instrumental Score | Baseline, Week 116 | ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis. | score on a scale | MEAN |
| SECONDARY | DBT Period: Number of Participants With AEs | From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks) | Safety-evaluable set included all participants randomized during the global phase, who received at least one dose of study drug. In the DBT period, three participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS | From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks) | Safety-evaluable set included all participants randomized during the global phase, who received at least one dose of study drug. In the DBT period, three participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set. Overall number analyzed is the number of participants with data available for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DBT Period: Number of Participants With ARIA-E Confirmed by MRI | From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks) | MRI Safety-evaluable analysis set included all participants in the Safety-evaluable analysis set who had at least one post-baseline safety MRI scan. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DBT Period: Number of Participants With ARIA-H Confirmed by MRI | From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks) | MRI Safety-evaluable analysis set included all participants in the Safety-evaluable analysis set who had at least one post-baseline safety MRI scan. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DBT Period: Number of Participants With Injection-Site Reactions | From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks) | Safety-evaluable set included all participants randomized during the global phase, who received at least one dose of study drug. In the DBT period, three participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DBT Period: Number of Participants With Anti-Drug Antibodies (ADA) to Gantenerumab | From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks) | ADA-evaluable analysis set included participants who received at least one dose of study drug and who provided at least one post-baseline ADA sample. In the DBT period, three participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm. As pre-specified in the protocol of study WN42171, ADA data for studies WN29922 and WN39658 from the OLE period will be reported in the results of study WN42171 (NCT04374253). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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