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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001365-24 | EudraCT Number |
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Decision to terminate development of Gantenerumab for treatment of prodromal/mild/early stage Alzheimer's disease following results of a pre-planned analysis of the safety and efficacy of Gant in Graduate I&II (WN29922/WN39658).
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This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 116. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gantenerumab | Experimental | Gantenerumab will be administered as SC injections with gradual uptitration. |
|
| Placebo | Placebo Comparator | Placebo will be administered as SC injections with gradual uptitration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gantenerumab | Drug | Gantenerumab will be administered as per the schedule specified in the respective arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| DBT Period: Change From Baseline to Week 116 in Global Outcome, as Measured by CDR-SB | 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. | Baseline, Week 116 |
| OLE Period: Number of Participants With Adverse Events (AEs) | An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. | From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) |
| OLE Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) | 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. | From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 13 (ADAS-Cog13) Score | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of Gantenerumab | Pre-dose on Days 1, Weeks 24, 52 and 76; Post-dose on Day 4, Weeks 41, 103, and 115 |
Key Inclusion criteria:
Key Exclusion criteria:
Exclusion for Open-Label Extension (OLE):
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Alzheimer?s Institute | Phoenix | Arizona | 85006 | United States | ||
| Barrow Neurological Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40603145 | Derived | Chandler JM, Lansdall CJ, Ye W, McDougall F, Belger M, Toth B, Mi X, Sink KM, Atkins AS. The Alzheimer's Disease Cooperative Study - Activities of Daily Living dependence score: revision and validation of an algorithm evaluating patient dependence across the spectrum of AD severity. J Prev Alzheimers Dis. 2025 Sep;12(8):100261. doi: 10.1016/j.tjpad.2025.100261. Epub 2025 Jul 1. | |
| 40302041 |
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Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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A total of 975 participants with early (prodromal to mild) Alzheimer's Disease (AD) were randomized to either the gantenerumab (n=498) or placebo arm (n=477) to enter the double-blind treatment (DBT) period.
Participants were enrolled in the study across 151 investigative sites in 18 countries from 22 August 2018 to 28 November 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo: DBT | Participants received, gantenerumab matching placebo, subcutaneous (SC) injections, every four weeks (Q4W) up to Week 36 and then every two weeks (Q2W) up to Week 114 of the DBT period. |
| FG001 | Gantenerumab: DBT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind Treatment Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 4, 2021 | Nov 10, 2023 |
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| Placebo | Drug | Placebo matching to gantenerumab will be administered as per the schedule specified in the respective arm. |
|
| OLE Period : Number of Participants With Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) Confirmed by MRI | 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. | From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) |
| OLE Period: Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI) | 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. | From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) |
| OLE Period: Number of Participants With Injection-Site Reactions | 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. | From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) |
| Baseline, Week 116 |
| DBT Period: Change From Baseline to Week 116 in Alzheimer's Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) Total Score | 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. | Baseline, Week 116 |
| DBT Period: Change From Baseline to Week 116 in Functional Activities Questionnaire (FAQ) Score | 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. | Baseline, Week 116 |
| DBT Period: Change From Baseline to Week 116 in Mini-Mental State Examination (MMSE) Total Score | 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. | Baseline, Week 116 |
| DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 11 (ADAS-Cog11) Score | 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. | Baseline, Week 116 |
| DBT Period: Change From Baseline to Week 116 in Verbal Fluency Task (VFT) Score | 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. | Baseline, Week 116 |
| DBT Period: Change From Baseline to Week 116 in the Coding (Digit Symbol Substitution Test [DSST]) Subtest | 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. | Baseline, Week 116 |
| DBT Period: Change From Baseline to Week 116 in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL) Instrumental Score | 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. | Baseline, Week 116 |
| DBT Period: Number of Participants With AEs | An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. | From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks) |
| DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS | 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. | From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks) |
| DBT Period: Number of Participants With ARIA-E Confirmed by MRI | 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. | From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks) |
| DBT Period: Number of Participants With ARIA-H Confirmed by MRI | 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. | From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks) |
| DBT Period: Number of Participants With Injection-Site Reactions | 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. | From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks) |
| DBT Period: Number of Participants With Anti-Drug Antibodies (ADA) to Gantenerumab | The number of participants with positive results for ADA against gantenerumab at any of the post-baseline assessment time-points were reported. Participant with an ADA assay result from at least one post-baseline sample was defined as a post-baseline evaluable participant. Treatment Emergent ADA = A participant with a negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. | From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks) |
| Change From Baseline to Week 116 in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan in a Subset of Participants | Brain amyloid load over time was assessed using [18F] florbetaben or [18F] flutemetamol tracers. These are PET radioligand selective to amyloid. Amyloid PET burden was measured in a composite region of interest (ROI) by using standardized uptake value ratio (SUVR) mapped to the centiloid scale. The weighted composite target region are composed of (both left and right side): frontal lobe, parietal lobe, temporal lobe lateral, cingulum posterior and anterior cingulate gyrus. The reference region used to normalize the composite region was the whole cerebellum. The centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. | Baseline, Week 116 |
| Change From Baseline to Week 116 in Brain Tau Load, as Measured by Tau PET Scan in a Subset of Participants | Change in tau load= how much neurofibrillary tau pathology is present in brain assessed by PET Scan. Tau PET radioligand used was [18F] GTP1. Tau load was measured using SUVR in 4 composite target ROIs: Temporal target region included (both left & right)=anterior &posterior superior temporal gyrus, posterior temporal lobe, fusiform gyrus, &middle &inferior temporal gyrus; Medial temporal region excluding hippocampus included (both left & right): amygdala, parahippocampus & anterior medial & lateral temporal lobe; Frontal lobe (both left & right) & Parietal lobe (both left & right). Inferior cerebellar grey matter=reference region for calculating SUVRs for 4 target regions. Tau-PET-mITT analysis set=all participants in ITT analysis set who participated in Tau PET sub-study & had at least one Tau PET scan with valid quantitative measurement & who did not withdraw from Tau PET substudy before randomization. Overall number analyzed=number of participants with data available for analysis. | Baseline, Week 116 |
| DBT Period: Percent Change From Baseline to Week 116 in Cerebrospinal Fluid (CSF) Marker of Disease in a Subset of Participants - Neurofilament Light Chain (NFL) | NFL is a neuronal cytoplasmic protein highly expressed in large, myelinated axons. Its levels increase in CSF and blood proportionally to the degree of axonal damage in a variety of neurological disorders, including AD. | Baseline, Week 116 |
| DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Neurogranin | Baseline, Week 116 |
| DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Total Tau (tTau) | CSF biomarker tTau has been considered as a general marker of neurodegeneration. An elevation in levels of tau, as well as specific pTau species, is thought to be a marker for progressive cellular degeneration in AD. | Baseline, Week 116 |
| DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Phosphorylated Tau (pTau-181) | CSF phospho-tau is an indicator of neuronal injury and neurodegeneration. CSF biomarker tTau has been considered as a general marker of neurodegeneration. An elevation in levels of pTau species, is thought to be a marker for progressive cellular degeneration in AD. | Baseline, Week 116 |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Banner Sun Health Research Insitute | Sun City | Arizona | 85351 | United States |
| Health Initiatives Research, PLLC | Fayetteville | Arkansas | 72703 | United States |
| Fullerton Neurology and Headache Center | Fullerton | California | 92835 | United States |
| Neurology Center of North Orange County | Fullerton | California | 92835 | United States |
| Irvine Center for Clinical Research | Irvine | California | 92614 | United States |
| Desert Valley Research | Redlands | California | 92374 | United States |
| Southern California Research LLC | Simi Valley | California | 93065 | United States |
| Yale University School Of Medicine | New Haven | Connecticut | 06519 | United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| Accel Research Sites - CRU Tampa | Bradenton | Florida | 34201 | United States |
| ClinCloud, LLC | Maitland | Florida | 32751 | United States |
| Optimus U Corp | Miami | Florida | 33125 | United States |
| Allied Biomedical Research Institute, Inc | Miami | Florida | 33155 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Intercoastal Medical Group | Sarasota | Florida | 34239 | United States |
| Infinity Clinical Research, LLC | Sunrise | Florida | 33351 | United States |
| Axiom Clinical Research of Florida | Tampa | Florida | 33609 | United States |
| Emory University | Atlanta | Georgia | 30329 | United States |
| Rush Alzheimer's Disease Cntr. | Chicago | Illinois | 60612 | United States |
| American Health Network Institute, LLC | Avon | Indiana | 46123 | United States |
| Brigham and Womens Hospital; Center for Alzheimer Research & Treatment | Boston | Massachusetts | 02115 | United States |
| ActivMed Practices and Research | Haverhill | Massachusetts | 01830 | United States |
| Boston Center for Memory | Newton | Massachusetts | 02459 | United States |
| Quest Research Institute | Farmington Hills | Michigan | 48334 | United States |
| Missouri Memory Center | Bolivar | Missouri | 65613 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center; Dept of Neurological Sciences | Omaha | Nebraska | 68198-8440 | United States |
| Cleveland Clinic Lou Ruvo; Center for Brain Research | Las Vegas | Nevada | 89106 | United States |
| The Cognitive and Research Center of New Jersey | Springfield | New Jersey | 07081 | United States |
| AD-CARE, University of Rochester Medical Center | Rochester | New York | 14620 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10314 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Behavioral Health Research | Charlotte | North Carolina | 28211 | United States |
| Alzheimer's Memory Center | Matthews | North Carolina | 28105 | United States |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607-6520 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| Neuro-Behavioral Clinical Research, Inc. | Canton | Ohio | 44718 | United States |
| Cleveland Clinic; Cleveland Lou Ruvo Center for Brain Health ? Neurological Institute | Cleveland | Ohio | 44195 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Summit Research Network Inc. | Portland | Oregon | 97210 | United States |
| Texas Neurology PA | Dallas | Texas | 75206 | United States |
| Kerwin Medical Center | Dallas | Texas | 75231 | United States |
| Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine | Houston | Texas | 77030 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77054 | United States |
| Hospital Italiano | Buenos Aires | C1181ACH | Argentina |
| Universidad Maimonides | Caba | C1405BCK | Argentina |
| Instituto Geriatrico Nuestra Señora de las Nieves | Capital Federal | C1427CCP | Argentina |
| Instituto Kremer | Córdoba | X5004AOA | Argentina |
| CEN Centro Especializado en Neurociencias | Córdoba | X5004FJF | Argentina |
| Instituto de Neurociencias San Agustín S.A. | La Plata | B1902AVF | Argentina |
| Fundacion Scherbovsky | Mendoza | M5500AYB | Argentina |
| AZ Sint Blasius (Dendermonde) | Dendermonde | 9200 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| Jessa Zkh (Campus Virga Jesse) | Hasselt | 3500 | Belgium |
| Psicomed Estudios Médicos | Antofagasta | 1270244 | Chile |
| Biomedica Research Group | Santiago | 7500710 | Chile |
| Especialidades Medicas LYS | Santiago | 7560356 | Chile |
| Clinical Hospital Centre Zagreb;Clinic for Neurology | Zagreb | 10000 | Croatia |
| Aarhus Universitetshospital; Neurologisk Afd. F, Demensklinikken | Aarhus N | 8200 | Denmark |
| Rigshospitalet, Hukommelsesklinikken | København Ø | 2100 | Denmark |
| Svendborg Sygehus; Neurologisk afdeling N, Demensklinik Fyn | Svendborg | 5700 | Denmark |
| Terveystalo Ruoholahti | Helsinki | 00180 | Finland |
| University of Eastern Finland | Kuopio | 70210 | Finland |
| Yachiyo Hospital | Aichi | 446-8510 | Japan |
| Nagoya Ekisaikai Hospital | Aichi | 454-8502 | Japan |
| National Center for Geriatrics and Gerontology | Aichi | 474-8511 | Japan |
| Fukuoka University Hospital | Fukuoka | 814-0180 | Japan |
| National Hospital Organization Hiroshima-Nishi Medical Center | Hiroshima | 739-0696 | Japan |
| Hyogo Prefectural HarimaHimeji General Medical Center | Hyōgo | 670-8560 | Japan |
| Tsukazaki Hospital | Hyōgo | 671-1227 | Japan |
| Matsui Dietary and Dementia Clinic | Hyōgo | 673-0891 | Japan |
| Kagawa Prefectural Central Hospital | Kagawa | 760-8557 | Japan |
| Rakuwakai Otowa Hospital | Kyoto | 607-8062 | Japan |
| Uji Takeda Hospital | Kyoto | 611-0021 | Japan |
| Rijikai Medical Corporation Katayama Medical Clinic | Okayama | 710-0813 | Japan |
| Kishiwada Tokushukai Hospital | Osaka | 596-0042 | Japan |
| National Hospital Organization Hizen Psychiatric Medical Center | Saga | 842-0192 | Japan |
| Medical corporation Ichiekai Itsuki Hospital | Tokushima | 770-0852 | Japan |
| Tokushima Hospital | Tokushima | 776-8585 | Japan |
| Mexico Centre for Clinical Research | Mexico City | Mexico CITY (federal District) | 03100 | Mexico |
| Hospital Universitario Dr Jose Eleuterio Gonzalez UANL; Depto.de NeurologíaPta.BajaConsulta | Monterrey | Nuevo León | 64460 | Mexico |
| AVIX Investigación Clínica S.C | Monterrey | Nuevo León | 64710 | Mexico |
| Hospital Angeles Culiacan; Neurociencias | Culiacán | Sinaloa | 80020 | Mexico |
| Brain Research Center B.V | Amsterdam | 1081 GN | Netherlands |
| O?rodek Badawczo-Naukowo-Dydaktyczny Chorób Ot?piennych w ?cinawie | ?cinawa | 59-330 | Poland |
| Podlaskie Centrum Psychogeriatrii | Bia?ystok | 15-756 | Poland |
| NZOZ Vitamed | Bydgoszcz | 85-079 | Poland |
| KO-MED Centra Kliniczne Lublin II | Lublin | 20-362 | Poland |
| Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych | Plewiska | 62-064 | Poland |
| NEURO-CARE Sp. z o.o. Sp. Komandytowa | Siemianowice ?l?skie | 41-100 | Poland |
| Senior Sp. Z O.O. Poradnia Psychogeriatryczna | Sopot | 81-855 | Poland |
| mMED Maciej Czarnecki | Warsaw | 01-684 | Poland |
| Pratia S.A. | Warsaw | 01-868 | Poland |
| NZOZ WCA | Wroc?aw | 53-659 | Poland |
| Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia | Amadora | 2720-276 | Portugal |
| Hospital de Braga; Servico de Neurologia | Braga | 4710-243 | Portugal |
| HUC; Servico de Neurologia | Coimbra | 3000-075 | Portugal |
| Hospital da Senhora da Oliveira-Guimarães; Serviço de Neurologia | Guimarães | Portugal |
| Hospital Geral de Santo Antonio; Servico de Neurologia | Porto | 4099-001 | Portugal |
| Santa Cruz Behavioral PSC | Bayamón | 00961 | Puerto Rico |
| University of Puerto Rico - Medical Science Campus; Internal Medicine | San Juan | 00936 | Puerto Rico |
| National University Hospital (NUH); Neuroscience | Singapore | 117549 | Singapore |
| National Neuroscience Institute; Neurology | Singapore | 308433 | Singapore |
| Dong-A University Hospital | Busan | 49201 | South Korea |
| Myongji Hospital | Gyeonggi-do | 10475 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Inha University Hospital | Incheon | 22332 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 463-707 | South Korea |
| Hanyang University Seoul Hospital | Seoul | 04763 | South Korea |
| Konkuk University Medical Center | Seoul | 05030 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Seoul St Mary's Hospital | Seoul | 06591 | South Korea |
| Ewha Womans University Hospital (Seoul) | Seoul | 07804 | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | 07985 | South Korea |
| Hospital General Universitario de Elche; Servicio de Neurología | Elche | Alicante | 03203 | Spain |
| Hospital Mutua De Terrasa; Servicio de Neurologia | Terrassa | Barcelona | 08222 | Spain |
| Hospital Virgen del Puerto. Servicio de Neurología | Plasencia | Caceres | 10600 | Spain |
| Policlínica Guipuzcoa; Servicio de Neurología | Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| Hospital Universitario de Santa Maria; Servicio de Neurología | Lleida | Lerida | 25198 | Spain |
| Hospital Quiron de Madrid; Servicio de Neurologia | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Clinica Universitaria de Navarra; Servicio de Neurología | Pamplona | Navarre | 31008 | Spain |
| Clinica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| CAE OROITU; Servicio de Neurología | Getxo | Vizcaya | 48993 | Spain |
| Hospital del Mar; Servicio de Neurologia | Barcelona | 08003 | Spain |
| Fundación ACE; Servicio de Neurología | Barcelona | 08028 | Spain |
| Universitario de La Princesa; Servicio de Neurología | Madrid | 28006 | Spain |
| Hospital Victoria Eugenia; Servico Neurología | Seville | Spain |
| Hospital Universitario la Fe; Servicio de Neurologia | Valencia | 46026 | Spain |
| Complejo Asistencial de Zamora; Servicio Psiquiatria | Zamora | 49021 | Spain |
| Skånes Universitetssjukhus Malmö, Minneskliniken | Malmö | 211 46 | Sweden |
| Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry | Mölndal | 431 41 | Sweden |
| KAROLINSKA UNI HOSPITAL, HUDDINGE; Mottagning Kognitiv Forskning, M54 | Stockholm | 141 86 | Sweden |
| Istanbul University Istanbul School of Medicine; Neurology | Istanbul | 34093 | Turkey (Türkiye) |
| Bezmialem Vakif Univ Medical | Istanbul | 34286 | Turkey (Türkiye) |
| Ondokuz Mayis Univ. Med. Fac.; Neurology | Samsun | 55139 | Turkey (Türkiye) |
| Royal Cornhill Hospital; OAP Directorate | Aberdeen | AB25 2ZH | United Kingdom |
| The Rice Centre; Royal United Hospital | Bath | BA1 3NG | United Kingdom |
| Re-Cognition | Birmingham | B16 8QQ | United Kingdom |
| The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre | Cheltenham | GL53 9DZ | United Kingdom |
| Surrey and Borders NHS Foundation Trust; Brain Science Research Unit | Chertsey | KT16 9AU | United Kingdom |
| Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit | Crowborough | TN6 1HB | United Kingdom |
| Ninewells Hospital | Dundee | DD12 9SY | United Kingdom |
| Queen Elizabeth University Hospital; Clinical Research Facility | Glasgow | G51 4TF | United Kingdom |
| St George's Hospital | London | SW17 0QT | United Kingdom |
| RE:Cognition Health | London | W1G 9RU | United Kingdom |
| Charing Cross Hospital | London | W6 8RF | United Kingdom |
| Campus for Ageing and Vitality | Newcastle | NE4 5PL | United Kingdom |
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| Royal Preston Hospital | Preston | PR2 9HT | United Kingdom |
| Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | S10 2JF | United Kingdom |
| University Southampton NHS Foundation Trust; Wessex Neurologica Centre | Southampton | SO166YD | United Kingdom |
| Derived |
| Asada T, Thanasopoulou A, Delmar P, Wojtowicz J, Smith J, Yoshiyama Y, Yokoi K, Watanabe C, Isozaki M, Ozaki R, Ishida T, Tatsuda H, Tamaoka A. Japanese participant data from three gantenerumab trials in early Alzheimer's disease. Alzheimers Dement. 2025 Apr;21(4):e70192. doi: 10.1002/alz.70192. |
| 39887500 | Derived | Bittner T, Tonietto M, Klein G, Belusov A, Illiano V, Voyle N, Delmar P, Scelsi MA, Gobbi S, Silvestri E, Barakovic M, Napolitano A, Galli C, Abaei M, Blennow K, Barkhof F. Biomarker treatment effects in two phase 3 trials of gantenerumab. Alzheimers Dement. 2025 Feb;21(2):e14414. doi: 10.1002/alz.14414. Epub 2025 Jan 30. |
| 39556389 | Derived | Salloway S, Wojtowicz J, Voyle N, Lane CA, Klein G, Lyons M, Rossomanno S, Mazzo F, Bullain S, Barkhof F, Bittner T, Schneider A, Grundman M, Aldea R, Boada M, Smith J, Doody R. Amyloid-Related Imaging Abnormalities (ARIA) in Clinical Trials of Gantenerumab in Early Alzheimer Disease. JAMA Neurol. 2025 Jan 1;82(1):19-29. doi: 10.1001/jamaneurol.2024.3937. |
| 37966285 | Derived | Bateman RJ, Smith J, Donohue MC, Delmar P, Abbas R, Salloway S, Wojtowicz J, Blennow K, Bittner T, Black SE, Klein G, Boada M, Grimmer T, Tamaoka A, Perry RJ, Turner RS, Watson D, Woodward M, Thanasopoulou A, Lane C, Baudler M, Fox NC, Cummings JL, Fontoura P, Doody RS; GRADUATE I and II Investigators and the Gantenerumab Study Group. Two Phase 3 Trials of Gantenerumab in Early Alzheimer's Disease. N Engl J Med. 2023 Nov 16;389(20):1862-1876. doi: 10.1056/NEJMoa2304430. |
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 milligrams (mg), Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
| FG002 | Placebo (DBT) to Gantenerumab: Open-label Extension (OLE) | 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. |
| FG003 | Gantenerumab (DBT) to Gantenerumab: OLE | Participants who received gantenerumab in the DBT period continued receiving gantenerumab, SC injections, 510 mg, Q2W up to Week 34 of the OLE period. |
| Safety-evaluable Set | Safety-evaluable set included all participants randomized during the global phase, who received at least one dose of study drug. In 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. |
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| COMPLETED |
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| NOT COMPLETED |
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| Open-label Extension Period |
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Intent-to-treat (ITT) analysis set included all participants randomized during the global phase, who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo: DBT | Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period. |
| BG001 | Gantenerumab: DBT | Participants 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 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Clinical Dementia Rating-Sum of Boxes (CDR-SB) | CDR was derived through semi-structured interview with participant and appropriate informant. It rated impairment across 6 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, 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. | 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. | Mean | Standard Deviation | score on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | DBT Period: Change From Baseline to Week 116 in Global Outcome, as Measured by CDR-SB | 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. | 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. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 116 |
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| Primary | OLE Period: Number of Participants With Adverse Events (AEs) | An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. | 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. | Posted | Count of Participants | Participants | From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) |
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| Primary | OLE Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) | 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. | 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. | Posted | Count of Participants | Participants | From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) |
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| Primary | OLE Period : Number of Participants With Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) Confirmed by MRI | 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. | MRI Safety-evaluable analysis set included all participants in the Safety-evaluable analysis set who had at least one post-baseline safety MRI scan. | Posted | Count of Participants | Participants | From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) |
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| Primary | OLE Period: Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI) | 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. | MRI Safety-evaluable analysis set included all participants in the Safety-evaluable analysis set who had at least one post-baseline safety MRI scan. | Posted | Count of Participants | Participants | From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) |
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| Primary | OLE Period: Number of Participants With Injection-Site Reactions | 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. | 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. | Posted | Count of Participants | Participants | From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) |
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| Secondary | DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 13 (ADAS-Cog13) Score | 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. | 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. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 116 |
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| Secondary | DBT Period: Change From Baseline to Week 116 in Alzheimer's Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) Total Score | 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. | 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. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 116 |
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| Secondary | DBT Period: Change From Baseline to Week 116 in Functional Activities Questionnaire (FAQ) Score | 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. | 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. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 116 |
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| Secondary | DBT Period: Change From Baseline to Week 116 in Mini-Mental State Examination (MMSE) Total Score | 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. | 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. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 116 |
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| Secondary | DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 11 (ADAS-Cog11) Score | 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. | 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. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 116 |
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| Secondary | DBT Period: Change From Baseline to Week 116 in Verbal Fluency Task (VFT) Score | 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. | 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. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 116 |
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| Secondary | DBT Period: Change From Baseline to Week 116 in the Coding (Digit Symbol Substitution Test [DSST]) Subtest | 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. | 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. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 116 |
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| Secondary | DBT Period: Change From Baseline to Week 116 in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL) Instrumental Score | 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. | 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. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 116 |
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| Secondary | DBT Period: Number of Participants With AEs | An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. | 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. | Posted | Count of Participants | Participants | From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks) |
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| Secondary | DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS | 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. | 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. | Posted | Count of Participants | Participants | From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks) |
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| Secondary | DBT Period: Number of Participants With ARIA-E Confirmed by MRI | 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. | MRI Safety-evaluable analysis set included all participants in the Safety-evaluable analysis set who had at least one post-baseline safety MRI scan. | Posted | Count of Participants | Participants | From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks) |
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| Secondary | DBT Period: Number of Participants With ARIA-H Confirmed by MRI | 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. | MRI Safety-evaluable analysis set included all participants in the Safety-evaluable analysis set who had at least one post-baseline safety MRI scan. | Posted | Count of Participants | Participants | From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks) |
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| Secondary | DBT Period: Number of Participants With Injection-Site Reactions | 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. | 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. | Posted | Count of Participants | Participants | From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks) |
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| Secondary | DBT Period: Number of Participants With Anti-Drug Antibodies (ADA) to Gantenerumab | The number of participants with positive results for ADA against gantenerumab at any of the post-baseline assessment time-points were reported. Participant with an ADA assay result from at least one post-baseline sample was defined as a post-baseline evaluable participant. Treatment Emergent ADA = A participant with a negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. | 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). | Posted | Count of Participants | Participants | From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks) |
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| Secondary | Change From Baseline to Week 116 in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan in a Subset of Participants | Brain amyloid load over time was assessed using [18F] florbetaben or [18F] flutemetamol tracers. These are PET radioligand selective to amyloid. Amyloid PET burden was measured in a composite region of interest (ROI) by using standardized uptake value ratio (SUVR) mapped to the centiloid scale. The weighted composite target region are composed of (both left and right side): frontal lobe, parietal lobe, temporal lobe lateral, cingulum posterior and anterior cingulate gyrus. The reference region used to normalize the composite region was the whole cerebellum. The centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. | Amyloid-PET-modified-ITT (mITT) included all participants in the ITT analysis set who participated in the Amyloid PET sub-study 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. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 116 |
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| Secondary | Change From Baseline to Week 116 in Brain Tau Load, as Measured by Tau PET Scan in a Subset of Participants | Change in tau load= how much neurofibrillary tau pathology is present in brain assessed by PET Scan. Tau PET radioligand used was [18F] GTP1. Tau load was measured using SUVR in 4 composite target ROIs: Temporal target region included (both left & right)=anterior &posterior superior temporal gyrus, posterior temporal lobe, fusiform gyrus, &middle &inferior temporal gyrus; Medial temporal region excluding hippocampus included (both left & right): amygdala, parahippocampus & anterior medial & lateral temporal lobe; Frontal lobe (both left & right) & Parietal lobe (both left & right). Inferior cerebellar grey matter=reference region for calculating SUVRs for 4 target regions. Tau-PET-mITT analysis set=all participants in ITT analysis set who participated in Tau PET sub-study & had at least one Tau PET scan with valid quantitative measurement & who did not withdraw from Tau PET substudy before randomization. Overall number analyzed=number of participants with data available for analysis. | 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 one tau PET substudy for participants willing to consent to the procedure. | Posted | Mean | Standard Error | SUVR | Baseline, Week 116 |
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| Secondary | DBT Period: Percent Change From Baseline to Week 116 in Cerebrospinal Fluid (CSF) Marker of Disease in a Subset of Participants - Neurofilament Light Chain (NFL) | NFL is a neuronal cytoplasmic protein highly expressed in large, myelinated axons. Its levels increase in CSF and blood proportionally to the degree of axonal damage in a variety of neurological disorders, including AD. | 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. | Posted | Geometric Mean | 95% Confidence Interval | percent change in NFL | Baseline, Week 116 |
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| Secondary | DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Neurogranin | 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. | Posted | Geometric Mean | 95% Confidence Interval | percent change in neurogranin | Baseline, Week 116 |
|
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| Secondary | DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Total Tau (tTau) | CSF biomarker tTau has been considered as a general marker of neurodegeneration. An elevation in levels of tau, as well as specific pTau species, is thought to be a marker for progressive cellular degeneration in AD. | 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. | Posted | Geometric Mean | 95% Confidence Interval | percent change in tTau | Baseline, Week 116 |
|
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| Secondary | DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Phosphorylated Tau (pTau-181) | CSF phospho-tau is an indicator of neuronal injury and neurodegeneration. CSF biomarker tTau has been considered as a general marker of neurodegeneration. An elevation in levels of pTau species, is thought to be a marker for progressive cellular degeneration in AD. | 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. | Posted | Geometric Mean | 95% Confidence Interval | percent change in pTau-181 | Baseline, Week 116 |
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| Other Pre-specified | Plasma Concentration of Gantenerumab | Pharmacokinetic(PK)-evaluable analysis set included participants who received at least one dose of study drug and who provided at least one valid post-baseline PK sample. | Posted | Pre-dose on Days 1, Weeks 24, 52 and 76; Post-dose on Day 4, Weeks 41, 103, and 115 |
|
|
DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants.
SAEs & other AEs reported based on safety-evaluable set=all participants randomized during global phase & received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug & entered OLE period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo: DBT | Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period. | 5 | 477 | 63 | 474 | 296 | 474 |
| EG001 | Gantenerumab: DBT | Participants 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 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period. | 7 | 498 | 61 | 501 | 358 | 501 |
| EG002 | Placebo (DBT) to Gantenerumab: OLE | 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. | 0 | 13 | 1 | 13 | 8 | 13 |
| EG003 | Gantenerumab (DBT) to Gantenerumab: OLE | Participants who received gantenerumab in the DBT period continued receiving gantenerumab, SC injections, 510 mg, Q2W up to Week 34 of the OLE period. | 0 | 14 | 0 | 14 | 6 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Chronic coronary syndrome | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Sinus arrhythmia | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | 25.0 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | 25.0 | Systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | 25.0 | Systematic Assessment |
| |
| Retinal vein occlusion | Eye disorders | 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 25.0 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | 25.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | 25.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | 25.0 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Asymptomatic COVID-19 | Infections and infestations | 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 25.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Endocarditis bacterial | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Helicobacter gastritis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Avulsion fracture | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Back injury | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Traumatic fracture | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | 25.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Spondylitis | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Invasive breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Ureteric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Cerebral haematoma | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Focal dyscognitive seizures | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Normal pressure hydrocephalus | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Peripheral paralysis | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Vertebrobasilar stroke | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | 25.0 | Systematic Assessment |
| |
| Delusion | Psychiatric disorders | 25.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 25.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | 25.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | 25.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | 25.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 25.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | 25.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | 25.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 25.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | 25.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | 25.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | 25.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 25.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Dacryocystitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Groin infection | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Bone fissure | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Periorbital haematoma | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Blood pressure diastolic decreased | Investigations | 25.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Amyloid related imaging abnormality-oedema/effusion | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | 25.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 25.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 25.0 | Systematic Assessment |
| |
| Pruritus genital | Reproductive system and breast disorders | 25.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 25.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | 25.0 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | 25.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 5, 2022 | Nov 10, 2023 | SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C571128 | gantenerumab |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
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| Units | Counts |
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| Participants |
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| OG001 | Gantenerumab (DBT) to Gantenerumab: OLE | Participants who received gantenerumab in the DBT period continued receiving gantenerumab, SC injections, 510 mg, Q2W up to Week 34 of the OLE period. |
|
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Participants who received gantenerumab in the DBT period continued receiving gantenerumab, SC injections, 510 mg, Q2W up to Week 34 of the OLE period.
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| OG001 | Gantenerumab: DBT | Participants 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 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period. |
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| Gantenerumab: DBT |
Participants 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 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period. |
|
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|
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
| OG001 | Gantenerumab: DBT | Participants 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 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period. |
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