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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019895-66 | EudraCT Number |
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This multi-center, randomized, double-blind, placebo-controlled parallel-group study will evaluate the effect of gantenerumab (RO4909832) on cognition and functioning and the safety and pharmacokinetics in participants with prodromal Alzheimer's Disease. Participants will be randomized to receive subcutaneous (SC) injections of either gantenerumab or placebo. Participants who consent to be part of the sub study will undergo positron emission tomography (PET) scanning to assess brain amyloid. The anticipated time on study treatment is 104 weeks in Part 1, with an option for an additional up to 2 years of treatment in Part 2, followed by an open-label extension (Part 3) until July 2020.
The dosing for Parts 1 and 2 was stopped after a planned futility interim analysis showed a low probability of meeting the primary outcome measure with the doses studied. The study has converted to open-label to investigate higher gantenerumab doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (Parts 1 and 2) | Placebo Comparator | Participants with Alzheimer's disease received Placebo by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
|
| Gantenerumab 105 mg (Parts 1 and 2) | Experimental | Participants with Alzheimer's disease received Gantenerumab 105 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
|
| Gantenerumab 225 mg (Parts 1 and 2) | Experimental | Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
|
| Placebo (Parts 1 and 2) switched to Gantenerumab Up to 1200mg (Part 3 Open-Label Extension [OLE]) | Placebo Comparator | Participants with Alzheimer's disease who had received Placebo by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gantenerumab | Drug | Participants received Gantenerumab at 105 mg , 225 mg, or at doses up to 1200 mg SC injection Q4W. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Total Score at Week 104 (Double-Blind Treatment Phase) | The CDR (Clinical Dementia Rating) is obtained through semi-structured interviews of participants and informants, and cognitive functioning is rated in six domains of functioning: memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a five-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment. The CDR-SOB (Clinical Dementia Rating-Sum of Boxes) is based on summing each of the domain box scores with total scores ranging from 0-18, where lower total scores represent better outcomes and higher total scores represent worse outcomes. | Baseline, Week 104 |
| Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) (OLE Phase) | An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Baseline up until a maximum of 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog-11) Scores at Week 104 (Double-Blind Treatment Phase) | The ADAS-Cog-11 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The score range for ADAS-Cog-11 is from 0 to 70 with higher scores representing severe dysfunction. |
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Inclusion Criteria:
Additional inclusion criteria for sub study:
Exclusion Criteria:
Additional exclusion criteria for sub study:
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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 | ||
| University of California, San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39686620 | Derived | Boada M, Neve A, Das B, Wojtowicz J, Huang Z, Bullain S, Watkin M, Lott D, Bittner T, Delmar P, Klein G, Hofmann C, Kerchner GA, Smith J, Baudler M, Fontoura P, Doody RS. Long-term safety of gantenerumab in participants with Alzheimer's disease: A phase III, open-label extension study (SCarlet RoAD). J Alzheimers Dis. 2025 Jan;103(2):528-541. doi: 10.1177/13872877241303644. Epub 2024 Dec 16. | |
| 39177596 |
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A total of 799 participants were randomised in this study. Of these, a total of 797 participants were enrolled and received at least one dose of any study drug and represented the Safety population during the Double-Blind Treatment Phase (Parts 1 and 2 of the study). From the Double-Blind Treatment Phase, a total of 154 participants (at 53 sites) were enrolled into Open-Label Extension (OLE) Phase (Part 3 of the study).
The study was conducted at 128 centers in 24 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (Parts 1 and 2) | Participants with Alzheimer's disease received Placebo by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind Treatment Phase |
|
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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 | Jul 9, 2018 | Sep 8, 2021 |
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|
| Gantenerumab Up to 1200 mg (Part 3 Open-Label Extension [OLE]) | Experimental | Participants with Alzheimer's disease who had received Gantenerumab by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years. |
|
| Placebo | Drug | Participants received Placebo SC injection Q4W. |
|
| Baseline, Week 104 |
| Time to Onset of Dementia at Week 104 (Double-Blind Treatment Phase) | Time to Onset of Dementia was defined as the time interval between the first treatment date and the date that participant is assessed as having Alzheimer-type dementia by investigators. | Baseline, Week 104 |
| Mean Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Composite Score at Week 104 (Double-Blind Treatment Phase) | The Cambridge Neuropsychological Test Automated Battery (CANTAB) ® is a cognitive test battery that incorporates a variety of executive and memory tasks in order to assess neuropsychological function. The end outcome as reported below, is a Z-Composite Score. The score range of the Z-Composite Score is from (-) infinity to (+) infinity with a score of zero representing the population mean, lower (negative) scores representing poorer cognitive outcomes and higher (positive) scores representing better cognitive outcomes. | Baseline, Week 104 |
| Mean Change From Baseline in Free and Cued Selective Reminding Test (FCSRT) Score at Week 104 (Double-Blind Treatment Phase) | FCSRT assesses verbal episodic memory. Performances in free recalls, cued recalls and in a recognition task were analyzed, as the process of encoding is controlled. Participants were asked to remember a list of 16 words. Three tasks of free and cued recalls, as well as 1 recognition task and one delayed recall give the scores. Total recall was obtained by the addition of cued recalls to free recalls. Maximum score is 48 for immediate: 16 words multiplied by (*) 3 corresponding to immediate free recall + immediate cued recall + immediate recognition test. Maximum score is 64 (better score) when delayed recall: 16 words*4. The minimum score is 0 (worse). | Baseline, Week 104 |
| Mean Change From Baseline in Functional Activities Questionnaire (FAQ) Score at Week 104 (Double-Blind Treatment Phase) | Participants completed the FAQ for physical function. Overall scores ranged from 0 (independent) to 30 (dependent) where lower scores represented an improvement in physical function. | Baseline, Week 104 |
| Mean Change From Baseline in CDR-Global Score at Week 104 (Double-Blind Treatment Phase) | The CDR-GS represents a semi-structured interview which rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care) on a 5-point scale in which CDR 0 = no dementia and CDR 0.5, 1, 2 or 3 = questionable, mild, moderate or severe dementia respectively. The range in scores for the CDR-GS is from 0 to 3 and a high score on the CDR-GS would indicate a high disease severity. | Baseline, Week 104 |
| Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Questionnaire Score at Week 104 (Double-Blind Treatment Phase) | The NPI is a retrospective (to 1 month) caregiver-informant interview assessing frequency and severity of 12 neuropsychiatric symptom domains. The NPI score is based on the sum of the severity ratings (0=absent, 1=mild, 3=severe). The 12 symptom domains include delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, nighttime behavioral disturbances, and appetite/eating abnormalities. The NPI severity score is based on severity ratings (0=absent, 1=mild to 3=severe). | Baseline, Week 104 |
| Percentage Change From Baseline in Cerebrospinal Fluid Biomarkers (Phosphorylated-tau [P-tau], Amyloid Beta 1-42 [Abeta 1-42], Total Tau [T-tau]) at Week 104 (Double-Blind Treatment Phase) | CSF biomarker phospho-tau (p-tau) is an indicator of neuronal injury and neurodegeneration. An elevation in levels of tau, as well as specific p-tau species, is thought to be a marker for progressive cellular degeneration in AD. | Baseline, Week 104 |
| Percentage Change From Baseline in Hippocampal Volume at Week 104 (Double-Blind Treatment Phase) | Change from baseline in hippocampal right volume (HRV) and hippocampal left volume (HLV) were analysed at Week 104 using magnetic resonance imaging. | Baseline, Week 104 |
| Percentage Change From Baseline in Cortical Composite Sustained Uptake Volume Ratio (SUVr) in Different Brain Regions at Week 156 (Double-Blind Treatment Phase) | The different regions of the brain that were analyzed included cerebellum gray, whole cerebellum, composite white matter, subcortical white matter, pons and composite reference. | Baseline, Week 156 |
| Gantenerumab Plasma Concentrations at Different Time Points (Double-Blind Treatment Phase) | The PK analyses includes tabulation of plasma concentration data and summarisation of plasma concentrations by visits with participants grouped according to treatment received. Descriptive summary statistics for the Arithmetic Mean and Standard Deviation are presented below. | Pre-Dose: Weeks 8, 20, 44, 68 and 100; Post-Dose: Weeks 1, 53 and 101 |
| Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 104 (Double-Blind Treatment Phase) | The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement. | Baseline, Week 104 |
| Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) (Double-Blind Treatment Phase) | An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Baseline up until a maximum of 4.5 years |
| Percentage of Participants With Anti-Drug Antibodies (ADAs) (Double-Blind Treatment Phase) | Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined for Gantenerumab and Placebo groups. The prevalence of ADA at baseline was calculated as the proportion of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the proportion of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis. | Baseline up until a maximum of 4.5 years |
| Mean Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog-11) Scores at Week 156 (OLE Phase) | The ADAS-Cog-11 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The score range for ADAS-Cog-11 is from 0 to 70 with higher scores representing severe dysfunction. | Baseline, Week 156 |
| Mean Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Total Score at Week 156 (OLE Phase) | The CDR (Clinical Dementia Rating) is obtained through semi-structured interviews of participants and informants, and cognitive functioning is rated in six domains of functioning: memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a five-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment. The CDR-SOB (Clinical Dementia Rating-Sum of Boxes) is based on summing each of the domain box scores with total scores ranging from 0-18, where lower total scores represent better outcomes and higher total scores represent worse outcomes. | Baseline, Week 156 |
| Mean Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog-13) Scores at Week 156 (OLE Phase) | The ADAS-Cog-13 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. The score range for ADAS-Cog-13 is from 0 to 85 with higher scores representing severe dysfunction. | Baseline, Week 156 |
| Time to Onset of Dementia at Week 156 (OLE Phase) | Time to Onset of Dementia was defined as the time interval between the first treatment date and the date that participant is assessed as having Alzheimer-type dementia by investigators. | Baseline, Week 156 |
| Mean Change From Baseline in Free and Cued Selective Reminding Test (FCSRT) Score at Week 156 (OLE Phase) | FCSRT assesses verbal episodic memory. Performances in free recalls, cued recalls and in a recognition task were analyzed, as the process of encoding is controlled. Participants were asked to remember a list of 16 words. Three tasks of free and cued recalls, as well as 1 recognition task and one delayed recall give the scores. Total recall was obtained by the addition of cued recalls to free recalls. Maximum score is 48 for immediate: 16 words multiplied by (*) 3 corresponding to immediate free recall + immediate cued recall + immediate recognition test. Maximum score is 64 (better score) when delayed recall: 16 words*4. The minimum score is 0 (worse). | Baseline, Week 156 |
| Mean Change From Baseline in Functional Activities Questionnaire (FAQ) Score at Week 156 (OLE Phase) | Participants completed the FAQ for physical function. Overall scores ranged from 0 (independent) to 30 (dependent) where lower scores represented an improvement in physical function. | Baseline, Week 156 |
| Mean Change From Baseline in CDR-Global Score at Week 156 (OLE Phase) | The CDR-GS represents a semi-structured interview which rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care) on a 5-point scale in which CDR 0 = no dementia and CDR 0.5, 1, 2 or 3 = questionable, mild, moderate or severe dementia respectively. The range in scores for the CDR-GS is from 0 to 3 and a high score on the CDR-GS would indicate a high disease severity. | Baseline, Week 156 |
| Percentage Change From Baseline in Hippocampal Volume at Week 152 (OLE Phase) | Change from baseline in hippocampal right volume (HRV) and hippocampal left volume (HLV) were analysed at Week 152 using magnetic resonance imaging. | Baseline, Week 152 |
| Percentage Change From Baseline in Cortical Composite Sustained Uptake Volume Ratio (SUVr) in Different Brain Regions at Week 156 (OLE Phase) | The regions of the brain that were analyzed included cerebellum gray and composite reference. | Baseline, Week 156 |
| Gantenerumab Plasma Concentrations at Different Time Points (OLE Phase) | The PK analyses includes tabulation of plasma concentration data and summarisation of plasma concentrations by visits with participants grouped according to treatment received. Descriptive summary statistics for the Arithmetic Mean and Standard Deviation are presented below. | Pre-Dose: Weeks 64, 100, 104, 136, 156 and 208; Post-Dose: Week 101 |
| Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 156 (OLE Phase) | The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement. | Baseline, Week 156 |
| Percentage of Participants With Anti-Drug Antibodies (ADAs) (OLE Phase) | Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined. The prevalence of ADA at baseline was calculated as the proportion of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the proportion of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis. | Baseline up until a maximum of 5 years |
| La Jolla |
| California |
| 92037 |
| United States |
| Yale University ADRU | New Haven | Connecticut | 06510 | United States |
| Brain Matters Research, Inc. | Delray Beach | Florida | 33445 | United States |
| Infinity Clinical Research | Hollywood | Florida | 33024 | United States |
| Accelerated Enrollment Solutions | Orlando | Florida | 32806 | United States |
| Roskamp Institute, Inc. | Sarasota | Florida | 34243 | United States |
| Compass Research | The Villages | Florida | 32162 | United States |
| Premiere Research Institute | West Palm Beach | Florida | 33407 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Boston Center for Memory | Newton | Massachusetts | 02459 | United States |
| Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research | Kalamazoo | Michigan | 49008 | United States |
| Neurological Research Center | Hattiesburg | Mississippi | 39401 | United States |
| Princeton Medical Institute | Princeton | New Jersey | 08540 | United States |
| Nathan Kline Institute | Orangeburg | New York | 10962 | United States |
| University of Rochester Medical Center; Monroe Community Hospital | Rochester | New York | 14627 | United States |
| Alzheimer's Memory Center | Matthews | North Carolina | 28105 | United States |
| Oregon Health and Science University, Layton Aging and Alzheimer's Disease Center | Portland | Oregon | 97239 | United States |
| Northeastern Pennsylvania Memory | Plains | Pennsylvania | 18705 | United States |
| Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island | 02914 | United States |
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
| Senior Adults Specialty Research | Austin | Texas | 78757 | United States |
| Texas Neurology PA | Dallas | Texas | 75206 | United States |
| Clinical Neuroscience Research Associates, Inc. | Bennington | Vermont | 05201 | United States |
| Hospital Italiano | Buenos Aires | C1181ACH | Argentina |
| IME - Instituto Médico Especializado; Ensayos Clínicos | Buenos Aires | C1405BCH | Argentina |
| ALPI-Inst. de Rehabilitacion Marcelo Fitte | Buenos Aires | C1425BWO | Argentina |
| CEMIC | Buenos Aires | C1431FWO | Argentina |
| Mulieris | CABA | C1022AAO | Argentina |
| Instituto De Neurología Cognitiva - INECO | Caba | C1126AAB | Argentina |
| FLENI | CABA | C1428AQK | Argentina |
| Instituto Kremer | Córdoba | X5004AOA | Argentina |
| CENPIA; Neurología - Psicología | La Plata | B1902AJU | Argentina |
| Hornsby Ku-ring-gai Hospital; Division of Rehabilitation & Aged Care | Hornsby | New South Wales | 2077 | Australia |
| Prince of Wales Hospital, Academic Department for Old Age Psychiatry | Randwick | New South Wales | 2031 | Australia |
| Royal Adelaide Hospital; Memory Trials Centre | Adelaide | South Australia | 5000 | Australia |
| The Queen Elizabeth Hospital; Neurology | Woodville | South Australia | 5011 | Australia |
| Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre | Heidelberg West | Victoria | 3081 | Australia |
| Australian Alzheimer's Research Foundation | Nedlands | Western Australia | 6009 | Australia |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Hospital das Clinicas - UFPR; Ciencias da Saude | Curitiba | Paraná | 80060-900 | Brazil |
| Hospital das Clinicas - UFRGS | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Hospital Mae de Deus | Porto Alegre | Rio Grande do Sul | 90470-340 | Brazil |
| Universidade Federal de Sao Paulo - UNIFESPX; Neurologia | São Paulo | São Paulo | 04024-002 | Brazil |
| Hospital das Clinicas - FMUSP; Psiquiatria | São Paulo | São Paulo | 05403-010 | Brazil |
| True North Clinical Research | New Minas | Nova Scotia | B4N 3R7 | Canada |
| Kawartha Centre - Redefining Healthy Aging | Peterborough | Ontario | K9H 2P4 | Canada |
| Toronto Memory Program | Toronto | Ontario | M3B 2S7 | Canada |
| Centre for Memory and Aging | Toronto | Ontario | M4G 3E8 | Canada |
| NeuroSearch Developpements inc | Greenfield Park | Quebec | J4V 2J2 | Canada |
| McGill University; Sir Mortimer B Davis Jewish General Hospital; Neurological and Psychiatric | Montreal | Quebec | H3T 1E2 | Canada |
| CHAUQ - Hôpital Enfant-Jésus | Québec | Quebec | G1J 1Z4 | Canada |
| Biomedica Research Group | Santiago | 7500710 | Chile |
| Especialidades Medicas LYS | Santiago | 7560356 | Chile |
| St. Anne´s University Hospital; Clinical Trials Department | Brno | 656 91 | Czechia |
| Vestra Clinics s.r.o. | Rychnov nad Kněžnou | 516 01 | Czechia |
| Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken | Aarhus N | 8200 | Denmark |
| Rigshospitalet, Hukommelsesklinikken | Koebenhavn Oe | 2100 | Denmark |
| CRST Oy | Turku | 20520 | Finland |
| Hopital Avicenne; Neurologie | Bobigny | 93009 | France |
| Hopital Pellegrin; Cmrr Aquitaine | Bordeaux | 33076 | France |
| Hopital Pierre Wertheimer; Laboratoire De Neuro Psychologie | Bron | 69677 | France |
| CHU De Caen; Service De Neurologie Dejerine | Caen | 14033 | France |
| Hopital B Roger Salengro; Cmrr Lille | Lille | 59037 | France |
| Ch Pitie Salpetriere; Cmrr Ile De France Salpetriere | Paris | 75651 | France |
| CHU de Rouen Hopital; Service de Neurologie | Rouen | 76031 | France |
| Hop Guillaume Et Rene Laennec; Cmrr St Herblain | Saint-Herblain | 44800 | France |
| Hopital Hautepierre; Centre dInvestigation Clinique | Strasbourg | 67098 | France |
| Hopital de La Grave | Toulouse | 31059 | France |
| Univ Berlin; Klin fur Psychi & Psycho Charite | Berlin | 12203 | Germany |
| Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin | Bonn | 53127 | Germany |
| Klinikum Joh.Wolfg.Goethe-UNI Zentrum d. Psychiatrie Klinik f. Psychiatrie Psychosomatik | Frankfurt | 60528 | Germany |
| PANAKEIA - Arzneimittelforschung Leipzig GmbH | Leipzig | 04275 | Germany |
| Zentralinstitut für Seelische Gesundheit Abt.Gerontopsychiatrie | Mannheim | 68159 | Germany |
| Pharmakologisches Studienzentrum | Mittweida | 09648 | Germany |
| Neurologische Praxis Dr. Andrej Pauls | München | 80331 | Germany |
| Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie | München | 81675 | Germany |
| Office of Dr Klaus Steinwachs Neurology & Psychiatry | Nuremberg | 90402 | Germany |
| Universitätsklinikum Rostock Zentrum für Nervenheilkunde | Rostock | 18147 | Germany |
| Universitätsklinikum Ulm; Klinik für Neurologie | Ulm | 89081 | Germany |
| Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica - Dipartimento di Neuroscienze | Modena | Emilia-Romagna | 41126 | Italy |
| Universita' Di Parma Istituto Neurologia | Parma | Emilia-Romagna | 43126 | Italy |
| Azienda Ospedaliera Spedali Civili; Scienze Neurologiche | Brescia | Lombardy | 25100 | Italy |
| IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer | Brescia | Lombardy | 25125 | Italy |
| Irccs Multimedica Santa Maria; Unita' Di Neurologia | Castellanza | Lombardy | 21053 | Italy |
| Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia | Milan | Lombardy | 20132 | Italy |
| Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona | Torrette - Ancona | The Marches | 60100 | Italy |
| Uni Di Firenze Dip. Scienze Neurol Psic Sod Neurologia 1 | Florence | Tuscany | 50134 | Italy |
| Hospital Mexico Americano | Guadalajara | Mexico CITY (federal District) | 44610 | Mexico |
| Hospital Universitario; Dr. Jose E. Gonzalez | Monterrey | Nuevo León | 64460 | Mexico |
| Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC | Culiacán | 80020 | Mexico |
| Unidad de Investigacion en Enfermedades Cronico-Degenerativa; Reumatologia | Guadalajara | 44620 | Mexico |
| Estimulacion Magnetica Trnscraneal de Mexico SC. | Mexico City | 11000 | Mexico |
| Centro Medico San Francisco; Geriatrics | Monterrey | 64710 | Mexico |
| Hospital Universitario de Saltillo | Saltillo | 25000 | Mexico |
| Jeroen Bosch Ziekenhuis; Polikliniek Geriatrie | 's-Hertogenbosch | 5223 GZ | Netherlands |
| Brain Research Center B.V | Amsterdam | 1081 GN | Netherlands |
| Podlaskie Centrum Psychogeriatrii | Bialystok | 15-756 | Poland |
| PALLMED Sp. z o.o. prowadząca NZOZ DOM SUE RYDER | Bydgoszcz | 85-796 | Poland |
| NEURO - KARD Ośrodek Badań Klinicznych | Poznan | 61-853 | Poland |
| Przychodnia Specjalistyczna PROSEN | Warsaw | 01-231 | Poland |
| mMED Maciej Czarnecki | Warsaw | 01-684 | Poland |
| Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia | Amadora | 2720-276 | Portugal |
| Hospital de Santa Maria; Servico de Neurologia | Lisbon | 1649-035 | Portugal |
| State autonomous institution of healthcare Inter-regional clinical and diagnostic center | Kazan' | 420101 | Russia |
| Saint Petersburg State Institution of Healthcare City Geriatric Medico-Social Center | Saint Petersburg | 190103 | Russia |
| Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department | Saint Petersburg | 194044 | Russia |
| City Clinical Hospital # 2 n.a. V.I. Razumovsky | Saratov | 410028 | Russia |
| Sverdlovsk Regional Clinical Psychoneurological War Veteran Hospital | Yekaterinburg | 620036 | Russia |
| Seoul National University Bundang Hospital; Neurology Department | Gyeonggi-do | 13620 | South Korea |
| Konkuk University Medical Center | Seoul | 05030 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Seoul St Mary's Hospital | Seoul | 06591 | South Korea |
| Asan Medical Center. | Seoul | 138-736 | South Korea |
| Fundació ACE | BArcelon | Barcelona | 08034 | Spain |
| Hospital Mutua De Terrasa; Servicio de Neurologia | Terrassa | Barcelona | 08222 | Spain |
| Hospital de Cruces; Servicio de Neurologia | Barakaldo | Vizcaya | 48903 | Spain |
| Hospital del Mar; Servicio de Neurologia | Barcelona | 08003 | Spain |
| Hospital Clinic i Provincial; Servicio de Neurologia | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia | Barcelona | 08041 | Spain |
| Hospital Ramon y Cajal; Servicio de Neurologia | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Neurologia | Madrid | 28041 | Spain |
| Hospital Universitario La Paz; Servicio de Neurologia | Madrid | 28046 | Spain |
| Hospital Universitario Dr. Peset; Servicio de Neurologia | Valencia | 46017 | Spain |
| Skånes Universitetssjukhus Malmö, Minneskliniken | Malmö | 211 46 | Sweden |
| Felix Platter-Spital Medizin Geriatrie | Basel | 4002 | Switzerland |
| HUG; Département de santé mentale et de psychiatrie Unité de psychiatrie gériatrique | Chêne-Bourg | 1225 | Switzerland |
| Akdeniz University School of Medicine, Neurology Department | Antalya | 07058 | Turkey (Türkiye) |
| Istanbul University Istanbul School of Medicine; Neurology | Istanbul | 34093 | Turkey (Türkiye) |
| Ondokuz Mayis University School of Medicine; Neurology | Samsun | 55239 | Turkey (Türkiye) |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Llandough Hospital; Llandough Hospital Memory Team 3rd Floor Academic Building | Cardiff | CF64 2XX | United Kingdom |
| St Margaret's Hospital | Epping | CM16 6TN | United Kingdom |
| Glasgow Memory Clinic | Glasgow | G20 0XA | United Kingdom |
| Charing Cross Hospital; Dept of Neurosciences | London | W6 8RF | United Kingdom |
| Campus for Ageing & Vitality; Clincal Ageing Research Unit | Newcastle | NE4 5PL | United Kingdom |
| Moorgreen Hospital; Memory Assessment & Rsch Ctr | Southampton | SO30 3JB | United Kingdom |
| Victoria Centre; Kingshill Research Centre | Swindon | SN3 6BW | United Kingdom |
| Hollins Park Hospital | Warrington | WA2 8WA | United Kingdom |
| Derived |
| Neve A, Das B, Wojtowicz J, Huang Z, Bullain S, Watkin M, Lott D, Bittner T, Delmar P, Klein G, Hofmann C, Kerchner GA, Smith J, Baudler M, Fontoura P, Doody RS. Long-Term Safety of Gantenerumab in Participants with Alzheimer's Disease: A Phase III, Double-Blind, and Open-Label Extension Study (Marguerite RoAD). J Alzheimers Dis. 2024;101(1):353-367. doi: 10.3233/JAD-240221. |
| 31831056 | Derived | Klein G, Delmar P, Voyle N, Rehal S, Hofmann C, Abi-Saab D, Andjelkovic M, Ristic S, Wang G, Bateman R, Kerchner GA, Baudler M, Fontoura P, Doody R. Gantenerumab reduces amyloid-beta plaques in patients with prodromal to moderate Alzheimer's disease: a PET substudy interim analysis. Alzheimers Res Ther. 2019 Dec 12;11(1):101. doi: 10.1186/s13195-019-0559-z. |
| 29221491 | Derived | Ostrowitzki S, Lasser RA, Dorflinger E, Scheltens P, Barkhof F, Nikolcheva T, Ashford E, Retout S, Hofmann C, Delmar P, Klein G, Andjelkovic M, Dubois B, Boada M, Blennow K, Santarelli L, Fontoura P; SCarlet RoAD Investigators. A phase III randomized trial of gantenerumab in prodromal Alzheimer's disease. Alzheimers Res Ther. 2017 Dec 8;9(1):95. doi: 10.1186/s13195-017-0318-y. |
| 22583155 | Derived | Delrieu J, Ousset PJ, Vellas B. Gantenerumab for the treatment of Alzheimer's disease. Expert Opin Biol Ther. 2012 Aug;12(8):1077-86. doi: 10.1517/14712598.2012.688022. Epub 2012 May 15. |
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| Gantenerumab 105 mg (Parts 1 and 2) |
Participants with Alzheimer's disease received Gantenerumab 105 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
| FG002 | Gantenerumab 225 mg (Parts 1 and 2) | Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
| FG003 | Placebo (Parts 1 and 2) Switched to Gantenerumab Up to 1200mg (Part 3 Open-Label Extension [OLE]) | Participants with Alzheimer's disease who had received Placebo by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years. |
| FG004 | Gantenerumab Up to 1200 mg (Part 3 Open-Label Extension [OLE]) | Participants with Alzheimer's disease who had received Gantenerumab by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years. |
| COMPLETED |
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| NOT COMPLETED |
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| Open-Label Extension (OLE) Phase |
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A total of 797 participants were enrolled into the Double-Blind Treatment phase of this study and the entire study. A subset (154) of these participants moved into the OLE phase of this study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (Parts 1 and 2) | Participants with Alzheimer's disease received Placebo by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
| BG001 | Gantenerumab 105 mg (Parts 1 and 2) | Participants with Alzheimer's disease received Gantenerumab 105 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
| BG002 | Gantenerumab 225 mg (Parts 1 and 2) | Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
| BG003 | Placebo (Parts 1 and 2) Switched to Gantenerumab Up to 1200mg (Part 3 Open-Label Extension [OLE]) | Participants with Alzheimer's disease who had received Placebo by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years. |
| BG004 | Gantenerumab Up to 1200 mg (Part 3 Open-Label Extension [OLE]) | Participants with Alzheimer's disease who had received Gantenerumab by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Parts 1 and 2 of the study. | Participants in the Double-Blind Treatment Phase of this study. | Mean | Standard Deviation | years |
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| Age, Continuous | Part 3 of the study. | Participants in the OLE Phase of this study. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Parts 1 and 2 of the study. | Participants in the Double-Blind Treatment Phase of this study. | Count of Participants | Participants |
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| Sex: Female, Male | Part 3 of the study. | Participants in the OLE Phase of this study. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Parts 1 and 2 of the study. | Participants in the Double-Blind Treatment Phase of this study. | Number | Participants |
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| Race/Ethnicity, Customized | Part 3 of the study. | Participants in the OLE Phase of this study. | Number | Participants |
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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 | Mean Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Total Score at Week 104 (Double-Blind Treatment Phase) | The CDR (Clinical Dementia Rating) is obtained through semi-structured interviews of participants and informants, and cognitive functioning is rated in six domains of functioning: memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a five-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment. The CDR-SOB (Clinical Dementia Rating-Sum of Boxes) is based on summing each of the domain box scores with total scores ranging from 0-18, where lower total scores represent better outcomes and higher total scores represent worse outcomes. | The Intent-To-Treat (ITT) population was defined as all participants who had received any dose of study treatment and had at least one post-baseline assessment of CDR-SOB. Data presented below is only for participants included in the actual analysis. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 104 |
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| Primary | Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) (OLE Phase) | An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | The Safety population was defined as all participants who had received at least one dose of Gantenerumab during the OLE phase. All participants in the Safety population also had at least one post-OLE baseline MRI. | Posted | Count of Participants | Participants | Baseline up until a maximum of 5 years |
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| Secondary | Mean Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog-11) Scores at Week 104 (Double-Blind Treatment Phase) | The ADAS-Cog-11 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The score range for ADAS-Cog-11 is from 0 to 70 with higher scores representing severe dysfunction. | The Intent-To-Treat (ITT) population was defined as all participants who had received any dose of study treatment and had at least one post-baseline assessment of CDR-SOB. Data presented below is only for participants included in the actual analysis. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 104 |
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| Secondary | Time to Onset of Dementia at Week 104 (Double-Blind Treatment Phase) | Time to Onset of Dementia was defined as the time interval between the first treatment date and the date that participant is assessed as having Alzheimer-type dementia by investigators. | The Intent-To-Treat (ITT) population was defined as all participants who had received any dose of study treatment and had at least one post-baseline assessment of CDR-SOB. | Posted | Median | 95% Confidence Interval | Days | Baseline, Week 104 |
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| Secondary | Mean Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Composite Score at Week 104 (Double-Blind Treatment Phase) | The Cambridge Neuropsychological Test Automated Battery (CANTAB) ® is a cognitive test battery that incorporates a variety of executive and memory tasks in order to assess neuropsychological function. The end outcome as reported below, is a Z-Composite Score. The score range of the Z-Composite Score is from (-) infinity to (+) infinity with a score of zero representing the population mean, lower (negative) scores representing poorer cognitive outcomes and higher (positive) scores representing better cognitive outcomes. | The Intent-To-Treat (ITT) population was defined as all participants who had received any dose of study treatment and had at least one post-baseline assessment of CDR-SOB. The Placebo Match Gantenerumab 225mg (Parts 1 and 2) arm consisted of participants with the ApoE 2e4 mutation who were excluded from the Gantenerumab 225 mg (Parts 1 and 2) arm. Data presented below is only for participants included in the actual analysis. | Posted | Mean | Standard Deviation | Z-Score | Baseline, Week 104 |
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| Secondary | Mean Change From Baseline in Free and Cued Selective Reminding Test (FCSRT) Score at Week 104 (Double-Blind Treatment Phase) | FCSRT assesses verbal episodic memory. Performances in free recalls, cued recalls and in a recognition task were analyzed, as the process of encoding is controlled. Participants were asked to remember a list of 16 words. Three tasks of free and cued recalls, as well as 1 recognition task and one delayed recall give the scores. Total recall was obtained by the addition of cued recalls to free recalls. Maximum score is 48 for immediate: 16 words multiplied by (*) 3 corresponding to immediate free recall + immediate cued recall + immediate recognition test. Maximum score is 64 (better score) when delayed recall: 16 words*4. The minimum score is 0 (worse). | The Intent-To-Treat (ITT) population was defined as all participants who had received any dose of study treatment and had at least one post-baseline assessment of CDR-SOB. The Placebo Match Gantenerumab 225mg (Parts 1 and 2) arm consisted of participants with the ApoE 2e4 mutation who were excluded from the Gantenerumab 225 mg (Parts 1 and 2) arm. Data presented below is only for participants included in the actual analysis. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 104 |
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| Secondary | Mean Change From Baseline in Functional Activities Questionnaire (FAQ) Score at Week 104 (Double-Blind Treatment Phase) | Participants completed the FAQ for physical function. Overall scores ranged from 0 (independent) to 30 (dependent) where lower scores represented an improvement in physical function. | The Intent-To-Treat (ITT) population was defined as all participants who had received any dose of study treatment and had at least one post-baseline assessment of CDR-SOB. The Placebo Match Gantenerumab 225mg (Parts 1 and 2) arm consisted of participants with the ApoE 2e4 mutation who were excluded from the Gantenerumab 225 mg (Parts 1 and 2) arm. Data presented below is only for participants included in the actual analysis. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 104 |
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| Secondary | Mean Change From Baseline in CDR-Global Score at Week 104 (Double-Blind Treatment Phase) | The CDR-GS represents a semi-structured interview which rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care) on a 5-point scale in which CDR 0 = no dementia and CDR 0.5, 1, 2 or 3 = questionable, mild, moderate or severe dementia respectively. The range in scores for the CDR-GS is from 0 to 3 and a high score on the CDR-GS would indicate a high disease severity. | The Intent-To-Treat (ITT) population was defined as all participants who had received any dose of study treatment and had at least one post-baseline assessment of CDR-SOB. The Placebo Match Gantenerumab 225mg (Parts 1 and 2) arm consisted of participants with the ApoE 2e4 mutation who were excluded from the Gantenerumab 225 mg (Parts 1 and 2) arm. Data presented below is only for participants included in the actual analysis. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 104 |
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| Secondary | Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Questionnaire Score at Week 104 (Double-Blind Treatment Phase) | The NPI is a retrospective (to 1 month) caregiver-informant interview assessing frequency and severity of 12 neuropsychiatric symptom domains. The NPI score is based on the sum of the severity ratings (0=absent, 1=mild, 3=severe). The 12 symptom domains include delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, nighttime behavioral disturbances, and appetite/eating abnormalities. The NPI severity score is based on severity ratings (0=absent, 1=mild to 3=severe). | The Intent-To-Treat (ITT) population was defined as all participants who had received any dose of study treatment and had at least one post-baseline assessment of CDR-SOB. The Placebo Match Gantenerumab 225mg (Parts 1 and 2) arm consisted of participants with the ApoE 2e4 mutation who were excluded from the Gantenerumab 225 mg (Parts 1 and 2) arm. Data presented below is only for participants included in the actual analysis. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 104 |
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| Secondary | Percentage Change From Baseline in Cerebrospinal Fluid Biomarkers (Phosphorylated-tau [P-tau], Amyloid Beta 1-42 [Abeta 1-42], Total Tau [T-tau]) at Week 104 (Double-Blind Treatment Phase) | CSF biomarker phospho-tau (p-tau) is an indicator of neuronal injury and neurodegeneration. An elevation in levels of tau, as well as specific p-tau species, is thought to be a marker for progressive cellular degeneration in AD. | The Intent-To-Treat (ITT) population was defined as all participants who had received any dose of study treatment and had at least one post-baseline assessment of CDR-SOB. The Placebo Match Gantenerumab 225mg (Parts 1 and 2) arm consisted of participants with the ApoE 2e4 mutation who were excluded from the Gantenerumab 225 mg (Parts 1 and 2) arm. Data presented below is only for participants included in the actual analysis. | Posted | Mean | Standard Deviation | Percentage Change | Baseline, Week 104 |
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| Secondary | Percentage Change From Baseline in Hippocampal Volume at Week 104 (Double-Blind Treatment Phase) | Change from baseline in hippocampal right volume (HRV) and hippocampal left volume (HLV) were analysed at Week 104 using magnetic resonance imaging. | The Intent-To-Treat (ITT) population was defined as all participants who had received any dose of study treatment and had at least one post-baseline assessment of CDR-SOB. The Placebo Match Gantenerumab 225mg (Parts 1 and 2) arm consisted of participants with the ApoE 2e4 mutation who were excluded from the Gantenerumab 225 mg (Parts 1 and 2) arm. Data presented below is only for participants included in the actual analysis. | Posted | Mean | Standard Deviation | Percentage Change | Baseline, Week 104 |
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| Secondary | Percentage Change From Baseline in Cortical Composite Sustained Uptake Volume Ratio (SUVr) in Different Brain Regions at Week 156 (Double-Blind Treatment Phase) | The different regions of the brain that were analyzed included cerebellum gray, whole cerebellum, composite white matter, subcortical white matter, pons and composite reference. | The Intent-To-Treat (ITT) population was defined as all participants who had received any dose of study treatment and had at least one post-baseline assessment of CDR-SOB. The Placebo Match Gantenerumab 225mg (Parts 1 and 2) arm consisted of participants with the ApoE 2e4 mutation who were excluded from the Gantenerumab 225 mg (Parts 1 and 2) arm. Data presented below is only for participants included in the actual analysis. | Posted | Mean | Standard Deviation | Percentage Change | Baseline, Week 156 |
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| Secondary | Gantenerumab Plasma Concentrations at Different Time Points (Double-Blind Treatment Phase) | The PK analyses includes tabulation of plasma concentration data and summarisation of plasma concentrations by visits with participants grouped according to treatment received. Descriptive summary statistics for the Arithmetic Mean and Standard Deviation are presented below. | The Intent-To-Treat (ITT) population was defined as all participants who had received any dose of study treatment and had at least one post-baseline assessment of CDR-SOB. Data presented below is only for participants included in the actual analysis and note that participants who received dose reduction were excluded from this PK analysis. | Posted | Mean | Standard Deviation | µg/ml (micrograms per milliliter) | Pre-Dose: Weeks 8, 20, 44, 68 and 100; Post-Dose: Weeks 1, 53 and 101 |
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| Secondary | Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 104 (Double-Blind Treatment Phase) | The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement. | The Intent-To-Treat (ITT) population was defined as all participants who had received any dose of study treatment and had at least one post-baseline assessment of CDR-SOB. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 104 |
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| Secondary | Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) (Double-Blind Treatment Phase) | An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | The Safety population was defined as all participants who had received at least one dose of study drug, regardless of whether the participant withdrew prematurely or not. All safety data was analyzed according to study drug actually received. | Posted | Count of Participants | Participants | Baseline up until a maximum of 4.5 years |
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| Secondary | Percentage of Participants With Anti-Drug Antibodies (ADAs) (Double-Blind Treatment Phase) | Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined for Gantenerumab and Placebo groups. The prevalence of ADA at baseline was calculated as the proportion of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the proportion of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis. | The Safety population was defined as all participants who had received at least one dose of study drug, regardless of whether the participant withdrew prematurely or not. All safety data was analyzed according to study drug actually received. Data presented below is only for participants included in the actual analysis. | Posted | Number | Percentage of Participants | Baseline up until a maximum of 4.5 years |
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| Secondary | Mean Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog-11) Scores at Week 156 (OLE Phase) | The ADAS-Cog-11 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The score range for ADAS-Cog-11 is from 0 to 70 with higher scores representing severe dysfunction. | The Safety population was defined as all participants who had received at least one dose of Gantenerumab during the OLE phase. All participants in the Safety population also had at least one post-OLE baseline MRI. Data presented below is only for participants included in the actual analysis. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 156 |
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| Secondary | Mean Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Total Score at Week 156 (OLE Phase) | The CDR (Clinical Dementia Rating) is obtained through semi-structured interviews of participants and informants, and cognitive functioning is rated in six domains of functioning: memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a five-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment. The CDR-SOB (Clinical Dementia Rating-Sum of Boxes) is based on summing each of the domain box scores with total scores ranging from 0-18, where lower total scores represent better outcomes and higher total scores represent worse outcomes. | The Safety population was defined as all participants who had received at least one dose of Gantenerumab during the OLE phase. All participants in the Safety population also had at least one post-OLE baseline MRI. Data presented below is only for participants included in the actual analysis. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 156 |
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| Secondary | Mean Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog-13) Scores at Week 156 (OLE Phase) | The ADAS-Cog-13 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. The score range for ADAS-Cog-13 is from 0 to 85 with higher scores representing severe dysfunction. | The Safety population was defined as all participants who had received at least one dose of Gantenerumab during the OLE phase. All participants in the Safety population also had at least one post-OLE baseline MRI. Data presented below is only for participants included in the actual analysis. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 156 |
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| Secondary | Time to Onset of Dementia at Week 156 (OLE Phase) | Time to Onset of Dementia was defined as the time interval between the first treatment date and the date that participant is assessed as having Alzheimer-type dementia by investigators. | The Safety population was defined as all participants who had received at least one dose of Gantenerumab during the OLE phase. All participants in the Safety population also had at least one post-OLE baseline MRI. Data presented below is only for participants included in the actual analysis. | Posted | Median | 95% Confidence Interval | Days | Baseline, Week 156 |
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| Secondary | Mean Change From Baseline in Free and Cued Selective Reminding Test (FCSRT) Score at Week 156 (OLE Phase) | FCSRT assesses verbal episodic memory. Performances in free recalls, cued recalls and in a recognition task were analyzed, as the process of encoding is controlled. Participants were asked to remember a list of 16 words. Three tasks of free and cued recalls, as well as 1 recognition task and one delayed recall give the scores. Total recall was obtained by the addition of cued recalls to free recalls. Maximum score is 48 for immediate: 16 words multiplied by (*) 3 corresponding to immediate free recall + immediate cued recall + immediate recognition test. Maximum score is 64 (better score) when delayed recall: 16 words*4. The minimum score is 0 (worse). | The Safety population was defined as all participants who had received at least one dose of Gantenerumab during the OLE phase. All participants in the Safety population also had at least one post-OLE baseline MRI. Data presented below is only for participants included in the actual analysis. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 156 |
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| Secondary | Mean Change From Baseline in Functional Activities Questionnaire (FAQ) Score at Week 156 (OLE Phase) | Participants completed the FAQ for physical function. Overall scores ranged from 0 (independent) to 30 (dependent) where lower scores represented an improvement in physical function. | The Safety population was defined as all participants who had received at least one dose of Gantenerumab during the OLE phase. All participants in the Safety population also had at least one post-OLE baseline MRI. Data presented below is only for participants included in the actual analysis. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 156 |
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| Secondary | Mean Change From Baseline in CDR-Global Score at Week 156 (OLE Phase) | The CDR-GS represents a semi-structured interview which rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care) on a 5-point scale in which CDR 0 = no dementia and CDR 0.5, 1, 2 or 3 = questionable, mild, moderate or severe dementia respectively. The range in scores for the CDR-GS is from 0 to 3 and a high score on the CDR-GS would indicate a high disease severity. | The Safety population was defined as all participants who had received at least one dose of Gantenerumab during the OLE phase. All participants in the Safety population also had at least one post-OLE baseline MRI. Data presented below is only for participants included in the actual analysis. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 156 |
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| Secondary | Percentage Change From Baseline in Hippocampal Volume at Week 152 (OLE Phase) | Change from baseline in hippocampal right volume (HRV) and hippocampal left volume (HLV) were analysed at Week 152 using magnetic resonance imaging. | The Safety population was defined as all participants who had received at least one dose of Gantenerumab during the OLE phase. All participants in the Safety population also had at least one post-OLE baseline MRI. Data presented below is only for participants included in the actual analysis. | Posted | Mean | Standard Deviation | Percentage Change | Baseline, Week 152 |
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| Secondary | Percentage Change From Baseline in Cortical Composite Sustained Uptake Volume Ratio (SUVr) in Different Brain Regions at Week 156 (OLE Phase) | The regions of the brain that were analyzed included cerebellum gray and composite reference. | The Safety population was defined as all participants who had received at least one dose of Gantenerumab during the OLE phase. All participants in the Safety population also had at least one post-OLE baseline MRI. Data presented below is only for participants included in the actual analysis. | Posted | Mean | Standard Deviation | Percentage Change | Baseline, Week 156 |
|
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| Secondary | Gantenerumab Plasma Concentrations at Different Time Points (OLE Phase) | The PK analyses includes tabulation of plasma concentration data and summarisation of plasma concentrations by visits with participants grouped according to treatment received. Descriptive summary statistics for the Arithmetic Mean and Standard Deviation are presented below. | The Safety population was defined as all participants who had received at least one dose of Gantenerumab during the OLE phase. All participants in the Safety population also had at least one post-OLE baseline MRI. Data presented below is only for participants included in the actual analysis and note that participants who received dose reduction were excluded from this PK analysis. | Posted | Mean | Standard Deviation | µg/ml (micrograms per milliliter) | Pre-Dose: Weeks 64, 100, 104, 136, 156 and 208; Post-Dose: Week 101 |
|
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| Secondary | Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 156 (OLE Phase) | The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement. | The Safety population was defined as all participants who had received at least one dose of Gantenerumab during the OLE phase. All participants in the Safety population also had at least one post-OLE baseline MRI. Data presented below is only for participants included in the actual analysis. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 156 |
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| Secondary | Percentage of Participants With Anti-Drug Antibodies (ADAs) (OLE Phase) | Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined. The prevalence of ADA at baseline was calculated as the proportion of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the proportion of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis. | The Safety population was defined as all participants who had received at least one dose of Gantenerumab during the OLE phase. All participants in the Safety population also had at least one post-OLE baseline MRI. Data presented below is only for participants included in the actual analysis. | Posted | Number | Percentage of Participants | Baseline up until a maximum of 5 years |
|
Baseline up until a maximum of 9.5 years
Not provided
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 (Parts 1 and 2) | Participants with Alzheimer's disease received Placebo by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. | 6 | 266 | 55 | 266 | 163 | 266 |
| EG001 | Gantenerumab 105 mg (Parts 1 and 2) | Participants with Alzheimer's disease received Gantenerumab 105 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. | 0 | 271 | 48 | 271 | 188 | 271 |
| EG002 | Gantenerumab 225 mg (Parts 1 and 2) | Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. | 2 | 260 | 46 | 260 | 189 | 260 |
| EG003 | Placebo (Parts 1 and 2) Switched to Gantenerumab Up to 1200mg (Part 3 Open-Label Extension [OLE]) | Participants with Alzheimer's disease who had received Placebo by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years. | 1 | 49 | 18 | 49 | 40 | 49 |
| EG004 | Gantenerumab Up to 1200 mg (Part 3 Open-Label Extension [OLE]) | Participants with Alzheimer's disease who had received Gantenerumab by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years. | 3 | 105 | 28 | 105 | 87 | 105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Biliary cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Laryngeal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Small cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| ARIA-E | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Cerebral haematoma | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Dementia with Lewy bodies | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Retrograde amnesia | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Thalamic infarction | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Delirium | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Delusion | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Neuropsychiatric symptoms | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Suicidal behaviour | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Rotator cuff repair | Surgical and medical procedures | MedDRA 23.1 | Non-systematic Assessment |
| |
| Urethral caruncle removal | Surgical and medical procedures | MedDRA 23.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Peripheral artery aneurysm | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Myocardial rupture | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Sinus arrest | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Diabetes insipidus | Endocrine disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Pancreatic mass | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Type I hypersensitivity | Immune system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Arthritis reactive | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Bladder obstruction | Renal and urinary disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA 23.1 | Non-systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA 23.1 | Non-systematic Assessment |
| |
| Spinal decompression | Surgical and medical procedures | MedDRA 23.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Malignant hypertension | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Amyotrophic lateral sclerosis | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Radial nerve palsy | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Transient global amnesia | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Lyme disease | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Pleural infection bacterial | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Benign ovarian tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Bone sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Breast cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Gastrointestinal tract adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Intestinal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Pharyngeal neoplasm benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Renal oncocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Post procedural haematuria | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Radiation mucositis | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Urinary retention postoperative | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Behavioral and psychological symptoms of dementia | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Urethral dilation procedure | Surgical and medical procedures | MedDRA 23.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Amyloid related imaging abnormality-oedema/effusion | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-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_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 13, 2020 | Sep 8, 2021 | SAP_001.pdf |
| 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
| Adverse Event |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Other |
|
|
|
|
|
|
| Hispanic |
|
|
| American Indian or Alaska native |
|
|
| Asian |
|
|
| Black |
|
|
| White |
|
|
| Not Available |
|
|
|
| Hispanic |
|
|
| American Indian or Alaska native |
|
|
| Asian |
|
|
| White |
|
|
| Unknown |
|
|
| Effect Size |
| -0.085 |
| 2-Sided |
| 95 |
| -0.304 |
| 0.135 |
| Superiority |
|
|
| OG002 | Gantenerumab 225 mg (Parts 1 and 2) | Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
|
|
|
Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
|
|
Participants with Alzheimer's disease received Gantenerumab 105 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
| OG002 | Gantenerumab 225 mg (Parts 1 and 2) | Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
| OG003 | Placebo Match Gantenerumab 225 mg (Parts 1 and 2) | Participants with Alzheimer's disease received matching Placebo to Gantenerumab 225 mg by SC injection q4w for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
|
|
| OG001 |
| Gantenerumab 105 mg (Parts 1 and 2) |
Participants with Alzheimer's disease received Gantenerumab 105 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
| OG002 | Gantenerumab 225 mg (Parts 1 and 2) | Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
| OG003 | Placebo Match Gantenerumab 225 mg (Parts 1 and 2) | Participants with Alzheimer's disease received matching Placebo to Gantenerumab 225 mg by SC injection q4w for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
|
|
| OG002 | Gantenerumab 225 mg (Parts 1 and 2) | Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
| OG003 | Placebo Match Gantenerumab 225 mg (Parts 1 and 2) | Participants with Alzheimer's disease received matching Placebo to Gantenerumab 225 mg by SC injection q4w for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
|
|
|
| OG002 | Gantenerumab 225 mg (Parts 1 and 2) | Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
| OG003 | Placebo Match Gantenerumab 225 mg (Parts 1 and 2) | Participants with Alzheimer's disease received matching Placebo to Gantenerumab 225 mg by SC injection q4w for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
|
|
| Gantenerumab 105 mg (Parts 1 and 2) |
Participants with Alzheimer's disease received Gantenerumab 105 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
| OG002 | Gantenerumab 225 mg (Parts 1 and 2) | Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
| OG003 | Placebo Match Gantenerumab 225 mg (Parts 1 and 2) | Participants with Alzheimer's disease received matching Placebo to Gantenerumab 225 mg by SC injection q4w for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
|
|
| OG002 | Gantenerumab 225 mg (Parts 1 and 2) | Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
| OG003 | Placebo Match Gantenerumab 225 mg (Parts 1 and 2) | Participants with Alzheimer's disease received matching Placebo to Gantenerumab 225 mg by SC injection q4w for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
|
|
|
| OG002 | Gantenerumab 225 mg (Parts 1 and 2) | Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
| OG003 | Placebo Match Gantenerumab 225 mg (Parts 1 and 2) | Participants with Alzheimer's disease received matching Placebo to Gantenerumab 225 mg by SC injection q4w for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
|
|
| OG002 | Gantenerumab 225 mg (Parts 1 and 2) | Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
| OG003 | Placebo Match Gantenerumab 225 mg (Parts 1 and 2) | Participants with Alzheimer's disease received matching Placebo to Gantenerumab 225 mg by SC injection q4w for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
|
|
|
|
| OG002 |
| Gantenerumab 225 mg (Parts 1 and 2) |
Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
|
|
| OG002 | Gantenerumab 225 mg (Parts 1 and 2) | Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
|
|
| Gantenerumab 105 mg (Parts 1 and 2) |
Participants with Alzheimer's disease received Gantenerumab 105 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
| OG002 | Gantenerumab 225 mg (Parts 1 and 2) | Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2. |
|
|
|
|
Participants with Alzheimer's disease who had received Gantenerumab by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
Participants with Alzheimer's disease who had received Gantenerumab by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
Participants with Alzheimer's disease who had received Gantenerumab by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years. |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|