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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001384-87 | Registry Identifier | EudraCT |
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Decision to terminate development of Gantenerumab for treatment of prodromal/mild/early-stage Alzheimer's disease following results of a pre-planned analysis of the safety and efficacy of Gant in Graduate I&II (WN29922/WN39658).
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This is a Phase II, multicenter, open-label, single arm, PD study in participants with early (prodromal to mild) AD to evaluate the effect of a once weekly (Q1W) dosing regimen of gantenerumab on deposited amyloid as measured by change from baseline to Week 104 (primary) and Week 208 in brain amyloid positron emission tomography (PET). The administration of gantenerumab as a single injection of Q1W will be investigated in this study, to simplify the dosing regimen for participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gantenerumab | Experimental | Participants will receive gantenerumab by subcutaneous (SC) injection at a dose of 120 mg every 4 weeks (Q4W) for 12 weeks, followed by 255 mg Q4W for 12 weeks, and 255 mg every 2 weeks (Q2W) for another 12 weeks, followed by the target dose 255 mg once weekly (Q1W) for up to Week 103. Participants who complete Week 104 visit will be given an option to take part in 2-year extension of the study to receive gantenerumab 255 mg Q1W for up to Week 207. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gantenerumab | Drug | Gantenerumab will be administered by SC injection at a dose of 120 mg Q4W for 12 weeks, followed by 255 mg Q4W for 12 weeks, and 255 mg Q2W for another 12 weeks, followed by the target dose 255 mg Q1W for up to Week 103 and an optional dose of 255 mg Q1W for up to Week 207. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Brain Amyloid Load at Week 104 as Measured by [18F] Florbetaben Positron Emission Tomography (PET) Scan | Screening amyloid PET scan was considered baseline evaluation.Brain amyloid load was quantified in terms of Standardized Uptake Value Ratio (SUVR),defined as ratio of tracer uptake in cortical composite target region of interest(ROI)to tracer uptake in reference ROI.Composite region: frontal,parietal,temporal,posterior cingulate cortex,anterior cingulate cortex. Reference ROI (whole cerebellum) was represented by weighted average of Cerebellum Ventral,Cerebellum Dorsal (left/right), Cerebellar White Matter.SUVR linearly transformed to standardized Centiloid Scale (CL) using formula CL=175.6xSUVR-174.2.CL ranges from <0 to >100, anchor points are 0=high-certainty amyloid negative scan and 100=amount of global amyloid deposition found in typical AD scan. | Baseline, Week 104 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ) | HAQ comprised 4 items completed by study partner capturing confidence (Q1), convenience (Q2), ease of use (Q3), and overall satisfaction (Q4) with administering medication. Response options Q1: Not at all confident, somewhat confident, confident, very confident; Q2: Not at all convenient, somewhat convenient, convenient, very convenient; Q3: Not at all easy, somewhat easy, easy, very easy; Q4:Not at all satisfied, somewhat satisfied, satisfied, very satisfied. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JEM Research LLC | Atlantis | Florida | 33462 | United States | ||
| ClinCloud, LLC |
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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This was a single-arm study and all participants received gantenerumab according to predefined universal up-titration scheme as follows: 120 mg every 4 weeks (Q4W) (Day 1, Week (W) 4, and W8), then 255 mg Q4W (W 12, 16, and 20), then 255 mg Q2W for 12 weeks (W 24, 26, 28, 30, 32, and 34), followed by target dose of 255 mg Q1W (W 36 to 104). Data was collected and reported in single arm for each participant who started treatment as specified and either completed or discontinued study.
Participants took part in this study at 33 investigative centers in the United States, Poland, Spain, Belgium, France, Germany, Italy, and the United Kingdom from 18 November 2020 up to 15 March 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gantenerumab | Participants received gantenerumab, subcutaneous (SC) injections with gradual up-titration starting at a dose of 120 mg, every 4 weeks (Q4W) on Day 1, Week 4, and Week 8, then 255 mg, Q4W on Weeks 12, 16, and 20, and then 255 mg every 2 weeks (Q2W) for 12 weeks (Weeks 24, 26, 28, 30, 32, and 34), followed by 255 mg every week (Q1W) up to Week 104 (Weeks 36 to 104). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | May 16, 2022 | Jan 10, 2024 |
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|
| Weeks 36, 52, 76, 104 |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE: any untoward medical occurrence in participant administered pharmaceutical product, which does not necessarily have a causal relationship with treatment. Also, any unfavorable, unintended sign, symptom, or disease temporally associated with use of medicinal product, whether or not considered related to it. SAE: any AE that was fatal, life threatening, required prolonged inpatient hospitalization, resulted in significant disability or resulted in a congenital anomaly to mother exposed to study treatment. This was a single-arm study and all participants received gantenerumab according to predefined universal up-titration scheme as follows: 120 mg Q4W (Day 1, Week (W) 4, and W8), then 255 mg Q4W (W 12, 16, and 20), then 255 mg Q2W for 12 weeks (W 24, 26, 28, 30, 32, and 34), followed by target dose of 255 mg Q1W (W 36 to 104). Data was collected and reported in single arm for each participant who started treatment as specified and either completed or discontinued study. | From day of first dose up to 16 weeks after the last dose (up to 120 weeks) |
| Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) | C-SSRS=assessment tool used to assess lifetime suicidality of a participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, & attempts with actual/potential lethality. Categories have binary responses (yes/no) & include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods(Not Plan)without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal);Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here. | From day of first dose up to 16 weeks after the last dose (up to 120 weeks) |
| Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI) | ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. The occurrences of imaging abnormalities in vasogenic edema and sulcal effusions (ARIA-E) were evaluated. | From day of first dose up to 16 weeks after the last dose (up to 120 weeks) |
| Number of Participants With Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) Confirmed by Magnetic Resonance Imaging (MRI) | ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. ARIA-H (H for hemosiderosis) are small foci of signal loss observed on MRI sequences sensitive for paramagnetic tissue properties and comprise cerebral microbleeds (small foci of bleeding in the brain parenchyma) and leptomeningeal hemosiderosis (small foci of bleeding on the surface of the brain). These changes also occur sporadically in AD. | From day of first dose up to 16 weeks after the last dose (up to 120 weeks) |
| Number of Participants With Injection-Site Reactions (ISR) | An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. Injection reactions (local and systemic) were defined as AEs that occured during or within 24 hours after study drug administration that were judged to be related to the study drug injection. | From day of first dose up to 16 weeks after the last dose (up to 120 weeks) |
| Number of Participants With Treatment-emergent Anti-Drug Antibodies to Gantenerumab | A participant with an ADA assay result from at least one post-baseline sample was defined as a post-baseline evaluable participant. Treatment Emergent ADA was defined as a participant with a negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result, or a participant with a positive ADA result at baseline who has at least one post-baseline titer results with at least a >2.5-fold increase in titer compared to baseline greater than the baseline titer result. | From day of first dose up to 16 weeks after the last dose (up to 120 weeks) |
| Plasma Concentration of Subcutaneous (SC) Gantenerumab at Specified Timepoints | Day 4 of Week 1, Week 24, 36, 52, and 76 |
| Change in Brain Amyloid Based on Different Dosing Frequency | The change from baseline at Week 52 using the once-weekly dosing frequency was analysed using the centiloid scale. The centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. The range of centiloid values can be below 0 (negative) and greater than 100. | Baseline up to Week 52 |
| Maitland |
| Florida |
| 32751 |
| United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| Alzheimer?s Research and Treatment Center | Wellington | Florida | 33414 | United States |
| Center for Advanced Research & Education | Gainesville | Georgia | 30501 | United States |
| Summit Research Network Inc. | Portland | Oregon | 97210 | United States |
| Abington Neurological Associates Willow Grove | Willow Grove | Pennsylvania | 19090 | United States |
| Jessa Zkh (Campus Virga Jesse) | Hasselt | 3500 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502) | Bron | 69677 | France |
| CH Pitie Salpetriere; IM2A | Paris | 75651 | France |
| Gerontopole; Centre de Recherche clinique | Toulouse | 31059 | France |
| Ambulates Gesundheitszentrum der Charité GmbH; MVZ Neurologie Campus Benjamin Franklin | Berlin | 12200 | Germany |
| ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic | Berlin | 13125 | Germany |
| Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie | München | 81675 | Germany |
| Ospedale Cardinale Panico; Dip.Ricerca Clinica in Neurologia ? UO Malattie Neurodegenerative | Tricase (LE) | Apulia | 73039 | Italy |
| Ospedale San Giovanni Calibita Fatebenefratell;Neurologia | Rome | Lazio | 00186 | Italy |
| Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia | Milan | Lombardy | 20132 | Italy |
| NZOZ Vitamed | Bydgoszcz | 85-079 | Poland |
| Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak. | Lublin | 20-410 | Poland |
| Senior Sp. Z O.O. Poradnia Psychogeriatryczna | Sopot | 81-855 | Poland |
| Centrum Medyczne Euromedis Sp. z o.o. | Szczecin | 70-111 | Poland |
| Centrum Medyczne NeuroProtect | Warsaw | 01-684 | Poland |
| NZOZ WCA | Wroc?aw | 53-659 | Poland |
| Policlínica Guipuzcoa; Servicio de Neurología | Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| Hospital Quiron de Madrid; Servicio de Neurologia | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Hospital Universitario de la Princesa; Servicio de Neurologia | Madrid | 28006 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Neurologia | Madrid | 28041 | Spain |
| Hospital Universitari i Politecnic La Fe; Servicio de Neurología | Valencia | 46026 | Spain |
| Re-Cognition | Birmingham | B16 8QQ | United Kingdom |
| Fritchie Centre | Cheltenham | GL53 9DZ | United Kingdom |
| Ninewells Hospital | Dundee | DD12 9SY | United Kingdom |
| Charing Cross Hospital; Imperial Memory Unit, Level 10 West | London | W6 8RF | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population set, included all enrolled participants (i.e., who gave informed consent, did not fail screening, and had at least one Amyloid PET scan with a valid quantitative measurement performed with either florbetaben or flutemetamol), whether or not the participant received the assigned treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Gantenerumab | Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W on Day 1, Week 4, and Week 8, then 255 mg, Q4W on Weeks 12, 16, and 20, and then 255 mg Q2W for 12 weeks (Weeks 24, 26, 28, 30, 32, and 34), followed by 255 mg Q1W up to Week 104 (Weeks 36 to 104). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Brain Amyloid Load at Week 104 as Measured by [18F] Florbetaben Positron Emission Tomography (PET) Scan | Screening amyloid PET scan was considered baseline evaluation.Brain amyloid load was quantified in terms of Standardized Uptake Value Ratio (SUVR),defined as ratio of tracer uptake in cortical composite target region of interest(ROI)to tracer uptake in reference ROI.Composite region: frontal,parietal,temporal,posterior cingulate cortex,anterior cingulate cortex. Reference ROI (whole cerebellum) was represented by weighted average of Cerebellum Ventral,Cerebellum Dorsal (left/right), Cerebellar White Matter.SUVR linearly transformed to standardized Centiloid Scale (CL) using formula CL=175.6xSUVR-174.2.CL ranges from <0 to >100, anchor points are 0=high-certainty amyloid negative scan and 100=amount of global amyloid deposition found in typical AD scan. | ITT population set, included all enrolled participants (i.e., who gave informed consent, did not fail screening, and had at least one Amyloid PET scan with a valid quantitative measurement performed with either florbetaben or flutemetamol), whether or not the participant received the assigned treatment. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Mean | Standard Deviation | centiloid | Baseline, Week 104 |
|
|
| |||||||||||||||||||||||||||
| Secondary | Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ) | HAQ comprised 4 items completed by study partner capturing confidence (Q1), convenience (Q2), ease of use (Q3), and overall satisfaction (Q4) with administering medication. Response options Q1: Not at all confident, somewhat confident, confident, very confident; Q2: Not at all convenient, somewhat convenient, convenient, very convenient; Q3: Not at all easy, somewhat easy, easy, very easy; Q4:Not at all satisfied, somewhat satisfied, satisfied, very satisfied. | Opportunity for Home Dosing Safety-Evaluable Analysis Set (OH-SE) included all participants of the SE analysis set who did not discontinue the study drug before week 26. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Count of Participants | Participants | Weeks 36, 52, 76, 104 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE: any untoward medical occurrence in participant administered pharmaceutical product, which does not necessarily have a causal relationship with treatment. Also, any unfavorable, unintended sign, symptom, or disease temporally associated with use of medicinal product, whether or not considered related to it. SAE: any AE that was fatal, life threatening, required prolonged inpatient hospitalization, resulted in significant disability or resulted in a congenital anomaly to mother exposed to study treatment. This was a single-arm study and all participants received gantenerumab according to predefined universal up-titration scheme as follows: 120 mg Q4W (Day 1, Week (W) 4, and W8), then 255 mg Q4W (W 12, 16, and 20), then 255 mg Q2W for 12 weeks (W 24, 26, 28, 30, 32, and 34), followed by target dose of 255 mg Q1W (W 36 to 104). Data was collected and reported in single arm for each participant who started treatment as specified and either completed or discontinued study. | Safety Evaluable population included all participants enrolled who received at least one dose of study treatment, whether prematurely withdrawn from the study or not. | Posted | Count of Participants | Participants | From day of first dose up to 16 weeks after the last dose (up to 120 weeks) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) | C-SSRS=assessment tool used to assess lifetime suicidality of a participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, & attempts with actual/potential lethality. Categories have binary responses (yes/no) & include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods(Not Plan)without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal);Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here. | Safety Evaluable population included all participants enrolled who received at least one dose of study treatment, whether prematurely withdrawn from the study or not. Overall number analyzed is the number of participants with data available for analysis. | Posted | Count of Participants | Participants | From day of first dose up to 16 weeks after the last dose (up to 120 weeks) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI) | ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. The occurrences of imaging abnormalities in vasogenic edema and sulcal effusions (ARIA-E) were evaluated. | MRI Safety-Evaluable Analysis Set included all participants of the SE analysis set who had at least one post-baseline MRI assessment. | Posted | Count of Participants | Participants | From day of first dose up to 16 weeks after the last dose (up to 120 weeks) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) Confirmed by Magnetic Resonance Imaging (MRI) | ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. ARIA-H (H for hemosiderosis) are small foci of signal loss observed on MRI sequences sensitive for paramagnetic tissue properties and comprise cerebral microbleeds (small foci of bleeding in the brain parenchyma) and leptomeningeal hemosiderosis (small foci of bleeding on the surface of the brain). These changes also occur sporadically in AD. | MRI Safety-Evaluable Analysis Set included all participants of the SE analysis set who had at least one post-baseline MRI assessment. | Posted | Count of Participants | Participants | From day of first dose up to 16 weeks after the last dose (up to 120 weeks) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Injection-Site Reactions (ISR) | An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. Injection reactions (local and systemic) were defined as AEs that occured during or within 24 hours after study drug administration that were judged to be related to the study drug injection. | Safety Evaluable population included all participants enrolled who received at least one dose of study treatment, whether prematurely withdrawn from the study or not. | Posted | Count of Participants | Participants | From day of first dose up to 16 weeks after the last dose (up to 120 weeks) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Anti-Drug Antibodies to Gantenerumab | A participant with an ADA assay result from at least one post-baseline sample was defined as a post-baseline evaluable participant. Treatment Emergent ADA was defined as a participant with a negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result, or a participant with a positive ADA result at baseline who has at least one post-baseline titer results with at least a >2.5-fold increase in titer compared to baseline greater than the baseline titer result. | Safety Evaluable population included all participants enrolled who received at least one dose of study treatment, whether prematurely withdrawn from the study or not. Overall number analyzed is the number of participants with an ADA assay result from at least one post-baseline sample. | Posted | Count of Participants | Participants | From day of first dose up to 16 weeks after the last dose (up to 120 weeks) |
|
| |||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of Subcutaneous (SC) Gantenerumab at Specified Timepoints | PK evaluable population included only participants that received the previous 6, 4, 6 or 6 planned doses at weeks 24, 36, 52 and 76, respectively. Overall number analyzed was the number of participants with data available for analysis. Number Analyzed was the number of participants with data available for analyses at the specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter | Day 4 of Week 1, Week 24, 36, 52, and 76 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Brain Amyloid Based on Different Dosing Frequency | The change from baseline at Week 52 using the once-weekly dosing frequency was analysed using the centiloid scale. The centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. The range of centiloid values can be below 0 (negative) and greater than 100. | ITT population set, included all enrolled participants (i.e., who gave informed consent, did not fail screening, and had at least one Amyloid PET scan with a valid quantitative measurement performed with either florbetaben or flutemetamol), whether or not the participant received the assigned treatment. Overall number analyzed is the number of participants with data available for analysis. | Posted | Mean | Standard Deviation | centiloid | Baseline up to Week 52 |
|
|
From day of first dose up to 16 weeks after the last dose (up to 120 weeks)
Safety Evaluable population. This was single-arm study and all participants received gantenerumab according to predefined universal up-titration scheme as follows: 120 mg Q4W (Day 1, Week (W) 4, and W8), then 255 mg Q4W (W 12, 16, and 20), then 255 mg Q2W for 12 weeks (W 24, 26, 28, 30, 32, and 34), followed by target dose of 255 mg Q1W (W 36 to 104). Data was collected and reported in single arm for each participant who started treatment as specified and either completed or discontinued study.
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 | Gantenerumab | Participants received gantenerumab, subcutaneous (SC) injections with gradual up-titration starting at a dose of 120 mg, every 4 weeks (Q4W) on Day 1, Week 4, and Week 8, then 255 mg, Q4W on Weeks 12, 16, and 20, and then 255 mg every 2 weeks (Q2W) for 12 weeks (Weeks 24, 26, 28, 30, 32, and 34), followed by 255 mg every week (Q1W) up to Week 104 (Weeks 36 to 104). | 1 | 192 | 26 | 192 | 144 | 192 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Cholesterolosis bulbi | Eye disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Gastrointestinal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.1 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.1 | Systematic Assessment |
| |
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.1 | Systematic Assessment |
| |
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.1 | Systematic Assessment |
| |
| Tumour inflammation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.1 | Systematic Assessment |
| |
| Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Amyloid related imaging abnormality-oedema/effusion | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Cerebellar ischaemia | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Giant cell arteritis | Vascular disorders | MedDRA version 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA version 25.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
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| Product dose omission issue | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Systematic Assessment |
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| Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
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| Amyloid related imaging abnormality-oedema/effusion | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
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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 | Jun 20, 2023 | Jan 10, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C571128 | gantenerumab |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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