Trial · NCT03444870
Outcomes38
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 38
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. | score on a scale | MEAN |
| PRIMARY | China Extension: DBT Period: Change From Baseline to Week 116 in Global Outcome, as Measured by CDR-SB | Baseline, Week 116 | The study was terminated early by the sponsor before any participant had reached Week 116 visit in the China extension phase. | ||
| 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. | 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 at Least One Adverse Event (AE) | From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks) | SE analysis set included all participants randomized during the global phase who received at least one dose of study drug. In the DBT period, four participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety analysis set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) | From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks) | SE analysis set included all participants randomized during the global phase who received at least one dose of study drug. In the DBT period, four participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety analysis 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 at Least One Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Magnetic Resonance Imaging (MRI) Finding | From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks) | SEMRI analysis set included all participants in the SE analysis set who had at least one post-baseline safety MRI scan. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DBT Period: Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) MRI Finding | From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks) | SEMRI analysis set included all participants in the SE 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 131 weeks) | SE analysis set included all participants randomized during the global phase who received at least one dose of study drug. In the DBT period, four participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety analysis 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 131 weeks) | SE analysis set included all participants randomized during the global phase who received at least one dose of study drug. In the DBT period, four participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety analysis set. Overall number analyzed is the number of participants with data available for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DBT Period: Change From Baseline to Week 116 in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan in a Subset of Participants | Baseline, Week 116 | Amyloid-PET modified ITT (mITT) analysis set included all participants in the ITT analysis set who participated in the Amyloid-PET substudy and who had at least one Amyloid-PET scan with a valid quantitative measurement performed with either florbetaben or flutemetamol and who did not withdraw from the Amyloid-PET substudy before randomization. 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 Brain Tau Load, as Measured by Tau PET Scan in a Subset of Participants | Baseline, Week 116 | As pre-specified in protocol/SAP, single tau PET substudy analyzed participants from 2 studies i.e. WN29922 (NCT03444870) \& WN39658 (NCT03443973), hence data for Tau PET was analyzed at pooled level of WN29922 \&WN39658. These studies had identical study design \& enrolled an Early AD population. Tau PET analysis was planned in a subset of participants, to get an optimum sample size for analysis, it was pre-planned to conduct 1 tau PET substudy for participants willing to consent to the procedure. | SUVR | MEAN |
| SECONDARY | DBT Period: Percent Change From Baseline to Week 116 in Cerebrospinal Fluid (CSF) Marker of Disease in a Subset of Participants - Total Tau (tTau) | Baseline, Week 116 | CSF mITT Analysis Set included all participants in the ITT analysis set who had at least one valid quantitative CSF measurement. Overall number analyzed is the number of participants with data available for analysis. | percent change in tTau | GEOMETRIC_MEAN |
| SECONDARY | DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Phosphorylated Tau (pTau-181) | Baseline, Week 116 | CSF modified ITT analysis set included all participants in the ITT analysis set who had at least one valid quantitative CSF measurement. Overall number analyzed is the number of participants with data available for analysis. | percent change in pTau-181 | GEOMETRIC_MEAN |
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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