Trial · NCT03444870
Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
NCT03444870, Phase 3, Terminated, Hoffmann-La Roche; results first posted 2024-01-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD). Trials, record NCT03444870. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03444870
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
- NCT number
- NCT03444870
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,053 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Alzheimer Disease
- Interventions
- Gantenerumab, Placebo
- First posted
- 2018-02-23
- Last updated
- 2024-01-30
- Other registries' IDs
- eudract:2017-001364-38
- Results first posted
- 2024-01-30
Source ClinicalTrials.gov
Registered outcomes38
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 | China Extension: 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. |
| 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. |
| Secondary | DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 11 (ADAS-Cog11) Score | Baseline, Week 116 | The ADAS-Cog11 was designed to measure cognitive symptom change in participants with Alzheimer's Disease (AD) and consisted of 11 tasks. The standard 11 items (and corresponding score range) were: word recall (0-10), commands (0-5), constructional praxis (0-5), naming objects and fingers (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), spoken language ability (0-5), comprehension of spoken language (0-5), word-finding difficulty (0-5), and remembering test instructions (0-5). The test included 7 performance items and 4 clinician-rated items. The ADAS-Cog11 total score was the sum of all 11 individual items, with a total score ranging from 0 (no impairment) to 70 (severe impairment). Higher scores indicated more severe cognitive impairment. A negative change from baseline indicates improvement. |
| Secondary | DBT Period: Change From Baseline to Week 116 in Verbal Fluency Task (VFT) Score | Baseline, Week 116 | VFT is a rater administered PerfO that measures speed and flexibility of verbal thought with a total score that ranges from 0-99 (lower scores indicating lower performance). A positive change from baseline indicates improvement. |
| Secondary | DBT Period: Change From Baseline to Week 116 in the Coding (Digit Symbol Substitution Test [DSST]) Subtest | Baseline, Week 116 | Coding, also called DSST is a rater administered PerfO that measures speed of processing and associative memory with a total score that ranges from 0-135 (lower scores indicating lower performance). The DSST was adapted from the Wechsler Adult Intelligence Scale. The 120-second version of the test was used in this study. Positive change from baseline indicates improvement. |
| 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 | The ADCS-iADL measures activities such as using the telephone, shopping and preparing a meal. The ADCS-iADL consists of 16 questions with a score range of 0 to 56 where a higher score represents better function. Positive change from baseline indicates improvement. |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 registered outcomesOutcomes38
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. | 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 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 outcomesResults by group97
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 | Global - DBT Period: Placebo | 3.65 | Standard Error 0.16 | score on a scale | |
| DBT Period: Change From Baseline to Week 116 in Global Outcome, as Measured by CDR-SB | Global - DBT Period: Gantenerumab | 3.35 | Standard Error 0.14 | score on a scale | |
| DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 13 (ADAS-Cog13) Score | Global - DBT Period: Placebo | 9.82 | Standard Error 0.57 | score on a scale | |
| DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 13 (ADAS-Cog13) Score | Global - DBT Period: Gantenerumab | 8.57 | Standard Error 0.47 | score on a scale | |
| DBT Period: Change From Baseline to Week 116 in Alzheimer's Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) Total Score | Global - DBT Period: Placebo | -12.32 | Standard Error 0.68 | score on a scale | |
| DBT Period: Change From Baseline to Week 116 in Alzheimer's Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) Total Score | Global - DBT Period: Gantenerumab | -11.21 | Standard Error 0.60 | score on a scale | |
| DBT Period: Change From Baseline to Week 116 in Functional Activities Questionnaire (FAQ) Score | Global - DBT Period: Placebo | 8.13 | Standard Error 0.33 | score on a scale | |
| DBT Period: Change From Baseline to Week 116 in Functional Activities Questionnaire (FAQ) Score | Global - DBT Period: Gantenerumab | 7.28 | Standard Error 0.30 | score on a scale | |
| DBT Period: Change From Baseline to Week 116 in Mini-Mental State Examination (MMSE) Total Score | Global - DBT Period: Placebo | -5.18 | Standard Error 0.25 | score on a scale | |
| DBT Period: Change From Baseline to Week 116 in Mini-Mental State Examination (MMSE) Total Score | Global - DBT Period: Gantenerumab | -4.86 | Standard Error 0.23 | score on a scale |
1 to 10 of 97Source ClinicalTrials.gov
See all 97 results by groupParticipant flow72
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Treatment (DBT) Period | STARTED | Global - DBT Period: Placebo | 486 | |
| Double-Blind Treatment (DBT) Period | STARTED | Global - DBT Period: Gantenerumab | 499 | |
| Double-Blind Treatment (DBT) Period | STARTED | China Extension - DBT Period: Placebo | 33 | |
| Double-Blind Treatment (DBT) Period | STARTED | China Extension - DBT Period: Gantenerumab | 35 | |
| Double-Blind Treatment (DBT) Period | STARTED | Global - OLE Period: Placebo (DBT) to Gantenerumab | 0 | |
| Double-Blind Treatment (DBT) Period | STARTED | Global - OLE Period: Gantenerumab (DBT) to Gantenerumab | 0 | |
| Double-Blind Treatment (DBT) Period | Intent-to-treat (ITT) Analysis Set | Global - DBT Period: Placebo | 485 | |
| Double-Blind Treatment (DBT) Period | Intent-to-treat (ITT) Analysis Set | Global - DBT Period: Gantenerumab | 499 | |
| Double-Blind Treatment (DBT) Period | Intent-to-treat (ITT) Analysis Set | China Extension - DBT Period: Placebo | 0 | |
| Double-Blind Treatment (DBT) Period | Intent-to-treat (ITT) Analysis Set | China Extension - DBT Period: Gantenerumab | 0 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 participant flowAdverse events1,374
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 | Global - DBT Period: Placebo | 1 | 481 | 1 |
| other | Arrhythmia | Cardiac disorders | Global - DBT Period: Gantenerumab | 0 | 503 | 0 |
| other | Arrhythmia | Cardiac disorders | China Extension - DBT Period: Placebo | 0 | 33 | 0 |
| other | Arrhythmia | Cardiac disorders | China Extension - DBT Period: Gantenerumab | 0 | 35 | 0 |
| other | Arrhythmia | Cardiac disorders | Global - OLE Period: Placebo (DBT) to Gantenerumab | 0 | 9 | 0 |
| other | Arrhythmia | Cardiac disorders | Global - OLE Period: Gantenerumab (DBT) to Gantenerumab | 2 | 20 | 3 |
| other | Cardiac failure chronic | Cardiac disorders | Global - DBT Period: Placebo | 1 | 481 | 1 |
| other | Cardiac failure chronic | Cardiac disorders | Global - DBT Period: Gantenerumab | 0 | 503 | 0 |
| other | Cardiac failure chronic | Cardiac disorders | China Extension - DBT Period: Placebo | 0 | 33 | 0 |
| other | Cardiac failure chronic | Cardiac disorders | China Extension - DBT Period: Gantenerumab | 0 | 35 | 0 |
1 to 10 of 1,374Source ClinicalTrials.gov
See all 1,374 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Global - DBT Period: Placebo | 11 | 481 |
| Total, all-cause mortality | Global - DBT Period: Gantenerumab | 3 | 503 |
| Total, all-cause mortality | China Extension - DBT Period: Placebo | 0 | 33 |
| Total, all-cause mortality | China Extension - DBT Period: Gantenerumab | 0 | 35 |
| Total, all-cause mortality | Global - OLE Period: Placebo (DBT) to Gantenerumab | 1 | 9 |
| Total, all-cause mortality | Global - OLE Period: Gantenerumab (DBT) to Gantenerumab | 0 | 20 |
| Total, other adverse events | Global - DBT Period: Placebo | 329 | 481 |
| Total, other adverse events | Global - DBT Period: Gantenerumab | 366 | 503 |
| Total, other adverse events | China Extension - DBT Period: Placebo | 11 | 33 |
| Total, other adverse events | China Extension - DBT Period: Gantenerumab | 20 | 35 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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 comparisons11
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 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-H MRI Finding | Trial comparisons |
| China Extension - DBT Period: Gantenerumab vs China Extension - DBT Period: Placebo: China - DBT Period: Number of Participants With Injection-Site Reactions | Trial comparisons |
| Global - DBT Period: Gantenerumab vs Global - DBT Period: Placebo: DBT Period: Number of Participants With Injection-Site Reactions | Trial comparisons |
| Global - OLE Period: Gantenerumab (DBT) to Gantenerumab vs Global - OLE Period: Placebo (DBT) to Gantenerumab: OLE Period: Number of Participants With at Least One AEs | Trial comparisons |
| China Extension - DBT Period: Gantenerumab vs China Extension - DBT Period: Placebo: China - DBT Period: Number of Participants With at Least One AE | Trial comparisons |
| Global - DBT Period: Gantenerumab vs Global - DBT Period: Placebo: DBT Period: Number of Participants With at Least One Adverse Event (AE) | Trial comparisons |
Global - DBT Period: Gantenerumab vs Global - DBT Period: Placebo: DBT Period: Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Magnetic Resonance Imaging (MRI) Finding | Trial comparisons |
| 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 |
| China Extension - DBT Period: Gantenerumab vs China Extension - DBT Period: Placebo: China - DBT Period: Number of Participants With at Least One ARIA-H MRI Finding | Trial comparisons |
Global - DBT Period: Gantenerumab vs Global - DBT Period: Placebo: DBT Period: Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) MRI Finding | Trial comparisons |
1 to 10 of 11
See all 11 trial comparisonsTests3
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/NCT03444870
GET https://conductscience.org/api/trials/v1/NCT03444870/registered?page=2