Trial · NCT03443973
Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
NCT03443973, Phase 3, Terminated, Hoffmann-La Roche; results first posted 2024-01-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD). Trials, record NCT03443973. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03443973
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
- NCT number
- NCT03443973
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 975 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Alzheimer Disease
- Interventions
- Gantenerumab, Placebo
- First posted
- 2018-02-23
- Last updated
- 2024-01-17
- Other registries' IDs
- eudract:2017-001365-24
- Results first posted
- 2024-01-17
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | DBT Period: Change From Baseline to Week 116 in Global Outcome, as Measured by CDR-SB | Baseline, Week 116 | CDR was derived through semi-structured interview with the participant and an appropriate informant, and it rated impairment across six domains: memory, orientation, judgment, and problem solving, community affairs, home and hobbies, and personal care on a 5-point scale for which 0=no impairment, 0.5=questionable impairment, and 1, 2, and 3=mild, moderate, and severe impairment, respectively. The CDR-SB is based on summing each of the domain box scores with total score ranging from 0-18 with higher scores reflecting greater cognitive and functional impairment. A negative change from baseline indicates improvement. |
| 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) | An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. |
| 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) | C-SSRS=assessment tool used to assess lifetime suicidality of a participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, \& attempts with actual/potential lethality. Categories have binary responses (yes/no) \& include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here. |
| 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) | ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. ARIA-H (H for hemosiderosis) are small foci of signal loss observed on MRI sequences sensitive for paramagnetic tissue properties and comprise cerebral microbleeds (small foci of bleeding in the brain parenchyma) and leptomeningeal hemosiderosis (small foci of bleeding on the surface of the brain). These changes also occur sporadically in AD. |
| 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) | 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. |
| 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) | An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. Local injection reactions (or injection site reactions) are defined as AEs related to the injection site that occur during or within 24 hours after study drug administration that are judged to be related to the study drug injection. |
| Secondary | DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 13 (ADAS-Cog13) Score | Baseline, Week 116 | The ADAS-Cog13 total score includes all of the items in the ADAS-Cog11 in addition to delayed word recall and the number cancellation. For the ADAS-cog 13 the range is 0-85 (score range for Delayed Word Recall \[DWR\] score is 0-10 and for Number Cancellation \[NC\] is 0-5, thus the score is ADAS-cog 11\[0-70\] plus the scores for DWR and NC). A higher score indicates worse performance. A negative change from baseline indicates improvement in cognitive function. |
| 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 | ADCS-ADL is a 23-item rater-administered, observer-reported outcome (ObsRO) that captures a participant's ability to perform basic activities of daily living (e.g., eating and toileting) and more complex ADL or instrumental activities of daily living (iADL, e.g., using the telephone, managing finances, preparing a meal). Total score ranges from 0-78, with higher scores reflecting better functioning. A positive change from baseline indicates improvement. |
| Secondary | DBT Period: Change From Baseline to Week 116 in Functional Activities Questionnaire (FAQ) Score | Baseline, Week 116 | FAQ is a rater-administered ObsRO (informant-based measure) that measures a participant's functional ability to perform complex higher-order activities. The observer provides performance ratings of the target person on ten complex higher-order activities. Total score that ranges from 0-30, with higher scores reflecting greater functional impairment. A negative change from baseline indicates improvement. |
| Secondary | DBT Period: Change From Baseline to Week 116 in Mini-Mental State Examination (MMSE) Total Score | Baseline, Week 116 | MMSE is a rater-administered performance-based outcome (PerfO) that includes a set of standardized questions used to evaluate possible cognitive impairment and help stage the severity level of this impairment. The questions target six areas: orientation, registration, attention, short-term recall, language, and constructional praxis/visuospatial abilities. Total score ranges from 0-30, with lower scores indicating greater impairment. A positive change from baseline indicates improvement. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group81
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| DBT Period: Change From Baseline to Week 116 in Global Outcome, as Measured by CDR-SB | Placebo: DBT | 3.01 | Standard Error 0.15 | score on a scale | |
| DBT Period: Change From Baseline to Week 116 in Global Outcome, as Measured by CDR-SB | Gantenerumab: DBT | 2.82 | Standard Error 0.14 | score on a scale | |
| OLE Period: Number of Participants With Adverse Events (AEs) | Placebo (DBT) to Gantenerumab: Open-label Extension (OLE) | 8 | Participants | ||
| OLE Period: Number of Participants With Adverse Events (AEs) | Gantenerumab (DBT) to Gantenerumab: OLE | 6 | Participants | ||
| OLE Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Placebo (DBT) to Gantenerumab: Open-label Extension (OLE) | Suicidal Ideation: Passive | 1 | Participants | |
| OLE Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Gantenerumab (DBT) to Gantenerumab: OLE | Suicidal Ideation: Passive | 0 | Participants | |
| OLE Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Placebo (DBT) to Gantenerumab: Open-label Extension (OLE) | Suicidal Ideation: Active-Method, but no Intent or Plan | 1 | Participants | |
| OLE Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Gantenerumab (DBT) to Gantenerumab: OLE | Suicidal Ideation: Active-Method, but no Intent or Plan | 0 | Participants | |
| OLE Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Placebo (DBT) to Gantenerumab: Open-label Extension (OLE) | Suicidal Ideation: No Event | 10 | Participants | |
| OLE Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Gantenerumab (DBT) to Gantenerumab: OLE | Suicidal Ideation: No Event | 13 | Participants |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Treatment Period | STARTED | Placebo: DBT | 477 | |
| Double-blind Treatment Period | STARTED | Gantenerumab: DBT | 498 | |
| Double-blind Treatment Period | STARTED | Placebo (DBT) to Gantenerumab: Open-label Extension (OLE) | 0 | |
| Double-blind Treatment Period | STARTED | Gantenerumab (DBT) to Gantenerumab: OLE | 0 | |
| Double-blind Treatment Period | Safety-evaluable Set | Placebo: DBT | 474 | |
| Double-blind Treatment Period | Safety-evaluable Set | Gantenerumab: DBT | 501 | |
| Double-blind Treatment Period | Safety-evaluable Set | Placebo (DBT) to Gantenerumab: Open-label Extension (OLE) | 0 | |
| Double-blind Treatment Period | Safety-evaluable Set | Gantenerumab (DBT) to Gantenerumab: OLE | 0 | |
| Double-blind Treatment Period | COMPLETED | Placebo: DBT | 397 | |
| Double-blind Treatment Period | COMPLETED | Gantenerumab: DBT | 372 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events648
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arrhythmia | Cardiac disorders | Placebo: DBT | 1 | 474 | 1 |
| other | Arrhythmia | Cardiac disorders | Gantenerumab: DBT | 2 | 501 | 2 |
| other | Arrhythmia | Cardiac disorders | Placebo (DBT) to Gantenerumab: OLE | 1 | 13 | 1 |
| other | Arrhythmia | Cardiac disorders | Gantenerumab (DBT) to Gantenerumab: OLE | 0 | 14 | 0 |
| other | Constipation | Gastrointestinal disorders | Placebo: DBT | 15 | 474 | 16 |
| other | Constipation | Gastrointestinal disorders | Gantenerumab: DBT | 11 | 501 | 12 |
| other | Constipation | Gastrointestinal disorders | Placebo (DBT) to Gantenerumab: OLE | 1 | 13 | 1 |
| other | Constipation | Gastrointestinal disorders | Gantenerumab (DBT) to Gantenerumab: OLE | 0 | 14 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo: DBT | 25 | 474 | 33 |
| other | Diarrhoea | Gastrointestinal disorders | Gantenerumab: DBT | 39 | 501 | 44 |
1 to 10 of 648Source ClinicalTrials.gov
See all 648 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo: DBT | 5 | 477 |
| Total, all-cause mortality | Gantenerumab: DBT | 7 | 498 |
| Total, all-cause mortality | Placebo (DBT) to Gantenerumab: OLE | 0 | 13 |
| Total, all-cause mortality | Gantenerumab (DBT) to Gantenerumab: OLE | 0 | 14 |
| Total, other adverse events | Placebo: DBT | 296 | 474 |
| Total, other adverse events | Gantenerumab: DBT | 358 | 501 |
| Total, other adverse events | Placebo (DBT) to Gantenerumab: OLE | 8 | 13 |
| Total, other adverse events | Gantenerumab (DBT) to Gantenerumab: OLE | 6 | 14 |
| Total, serious adverse events | Placebo: DBT | 63 | 474 |
| Total, serious adverse events | Gantenerumab: DBT | 61 | 501 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Placebo: DBT vs Gantenerumab: DBT: DBT Period: Number of Participants With ARIA-H Confirmed by MRI | Trial comparisons |
Placebo (DBT) to Gantenerumab: Open-label Extension (OLE) vs Gantenerumab (DBT) to Gantenerumab: OLE: OLE Period : Number of Participants With Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) Confirmed by MRI | Trial comparisons |
| Placebo (DBT) to Gantenerumab: Open-label Extension (OLE) vs Gantenerumab (DBT) to Gantenerumab: OLE: OLE Period: Number of Participants With Adverse Events (AEs) | Trial comparisons |
| Placebo: DBT vs Gantenerumab: DBT: DBT Period: Number of Participants With AEs | Trial comparisons |
| Placebo (DBT) to Gantenerumab: Open-label Extension (OLE) vs Gantenerumab (DBT) to Gantenerumab: OLE: OLE Period: Number of Participants With Injection-Site Reactions | Trial comparisons |
Placebo (DBT) to Gantenerumab: Open-label Extension (OLE) vs Gantenerumab (DBT) to Gantenerumab: OLE: OLE Period: Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI) | Trial comparisons |
| Placebo: DBT vs Gantenerumab: DBT: DBT Period: Number of Participants With ARIA-E Confirmed by MRI | Trial comparisons |
| Placebo: DBT vs Gantenerumab: DBT: DBT Period: Number of Participants With Injection-Site Reactions | Trial comparisons |
Tests3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Delayed Recall Module | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03443973
GET https://conductscience.org/api/trials/v1/NCT03443973/registered?page=2