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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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The main purpose of the study was to evaluate the safety and tolerability of long-term administration of gantenerumab in participants with AD. All participants who have completed the open-label extensions (OLEs) of studies WN25203 or WN28745 were enrolled in Part 1 of this study. Of these, participants who completed Week 104 visit in Part 1. Participants received open-label gantenerumab by subcutaneous (SC) injection every four weeks (Q4W) at the same dose as administered in the parent studies (part 1)/ Week 104 visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCarlet RoAD | Experimental | Participants enrolled from the open label extension (OLE) part of parent study WN25203, received gantenerumab, up to 1200 milligram (mg), subcutaneous (SC) injection, every 4 weeks (Q4W) for up to 129 weeks. |
|
| Marguerite RoAD | Experimental | Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gantenerumab | Drug | Gantenerumab was administered as SC injection Q4W. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was defined as any untoward medical occurrence in a participant administered with gantenerumab and which does not necessarily have a causal relationship with gantenerumab. A Serious Adverse Event (SAE) is any significant hazard, contraindication, side effect that is fatal or life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above, and which does not necessarily have a causal relationship with gantenerumab. | Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) |
| Number of Participants With Change in Any Suicidal Ideation or Behavior as Assessed by 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= no suicide risk present. Score of 1 or higher= suicidal ideation/behavior. Number of participants with any suicidal ideation/behavior were reported. | Baseline (Day 1), up to Week 104 |
| Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) AEs | Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) | |
| Number of Participants With Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) AEs |
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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 |
|---|---|---|---|---|---|---|
| Banner Sun Health Research Insitute | Sun City | Arizona | 85351 | United States | ||
| California Neuroscience Research Medical Group, Inc |
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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A total of 116 participants rolled over in this study of which 115 participants received gantenerumab in part 1. 59 participants rolled over from OLE WN25203 & 56 participants rolled over from WN28745. Due to negative pre-planned analysis of studies WN39658 & WN29922, this study was terminated by sponsor, & no participant was rolled over to Part 2.
Participants took part in Part 1 of the study at 56 centers in the United States, Spain, Canada, Italy, Germany, Japan, Korea, Mexico, Poland, Turkey, Australia, Russia, Argentina, Switzerland, Chile, Denmark, and Netherlands from 22 May 2020 to 04 Jan 2023. The study was terminated before Part 2 was initiated.
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| ID | Title | Description |
|---|---|---|
| FG000 | SCarlet RoAD | Participants enrolled from the open label extension (OLE) part of parent study WN25203, received gantenerumab, up to 1200 milligram (mg), subcutaneous (SC) injection, every 4 weeks (Q4W) for up to 129 weeks. |
| FG001 | Marguerite RoAD |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 27, 2022 |
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| Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) |
| Number of Participants With Anti-drug Antibody (ADA) to Gantenerumab | Up to Week 133 |
| Number of Participants With Injection-Site Reactions | Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) |
| Number of Participants Who Discontinued Treatment Due to AEs | An AE was defined as any untoward medical occurrence in a participant administered with gantenerumab and which does not necessarily have a causal relationship with gantenerumab. SAE is any significant hazard, contraindication, side effect that is fatal or life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above, and which does not necessarily have a causal relationship with gantenerumab. | Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) |
| Sherman Oaks |
| California |
| 91403 |
| United States |
| Accelerated Enrollment Solutions | Orlando | Florida | 32806 | United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| Bioclinica The Villages | The Villages | Florida | 32162 | United States |
| Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research | Kalamazoo | Michigan | 49008 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10314 | United States |
| Alzheimer's Memory Center | Matthews | North Carolina | 28105 | United States |
| Central States Research | Tulsa | Oklahoma | 74136 | United States |
| Neurology Clinic PC | Cordova | Tennessee | 38018 | United States |
| Senior Adults Specialty Research | Austin | Texas | 78757 | United States |
| Instituto Neurologia Bs As | Ciudad Autonoma Buenos Aires | C1426ANZ | Argentina |
| The Queen Elizabeth Hospital; Neurology | Woodville | South Australia | 5011 | Australia |
| Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre | Heidelberg West | Victoria | 3081 | Australia |
| Centricity Research | Halifax | Nova Scotia | B3S 1N2 | Canada |
| True North Clinical Research-Halifax | Halifax | Nova Scotia | B3S 1N2 | Canada |
| Kawartha Centre - Redefining Healthy Aging | Peterborough | Ontario | K9H 2P4 | Canada |
| Toronto Memory Program | Toronto | Ontario | M3B 2S7 | Canada |
| Alpha Recherche Clinique | Québec | G3K 2P8 | Canada |
| Especialidades Medicas LYS | Santiago | 7560356 | Chile |
| Rigshospitalet, Hukommelsesklinikken | København Ø | 2100 | Denmark |
| Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica ? Dipartimento di Neuroscienze | Modena | Emilia-Romagna | 41126 | 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 |
| Medical Corporation Hakuyokai Kashiwado Hospital | Chiba | 260-8656 | Japan |
| Juntendo University Urayasu Hospital; Neurology | Chiba | 279-0021 | Japan |
| National Hospital Organization Hiroshima-Nishi Medical Center | Hiroshima | 739-0696 | Japan |
| Hospital Mexico Americano | Guadalajara | Mexico CITY (federal District) | 44610 | Mexico |
| Hospital Universitario; Dr. Jose E. Gonzalez | Monterrey | Nuevo León | 64460 | Mexico |
| AVIX Investigación ClÃnica S.C | Monterrey | Nuevo León | 64710 | Mexico |
| Brain Research Center B.V | Amsterdam | 1081 GN | Netherlands |
| NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek | Późna | 61-853 | Poland |
| Przychodnia Specjalistyczna PROSEN | Warsaw | 01-231 | Poland |
| Centrum Medyczne NeuroProtect | Warsaw | 01-684 | Poland |
| Saint Petersburg State Institution of Healthcare City Geriatric Medico-Social Center | Saint Petersburg | Sankt-Peterburg | 190103 | Russia |
| FSMEI HPE ?Military Medical Academy n.a. S.M.Kirov"of Minist | Saint Petersburg | Sankt-Peterburg | 194044 | Russia |
| Inha University Hospital | Incheon | 22332 | South Korea |
| Seoul St Mary's Hospital | Seoul | 06591 | South Korea |
| Ewha Womans University Hospital (Seoul) | Seoul | 07804 | South Korea |
| Hospital General Universitario de Elche; Servicio de NeurologÃa | Elche | Alicante | 03203 | Spain |
| Hospital Mutua De Terrasa; Servicio de Neurologia | Terrassa | Barcelona | 08222 | Spain |
| Hospital del Mar; Servicio de Neurologia | Barcelona | 08003 | Spain |
| Fundación ACE; Servicio de NeurologÃa | Barcelona | 08028 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Neurologia | Madrid | 28041 | Spain |
| Hospital Universitario Dr. Peset; Servicio de Neurologia | Valencia | 46017 | Spain |
| Hospital Universitario la Fe; Servicio de Neurologia | Valencia | 46026 | Spain |
| Felix Platter-Spital Medizin Geriatrie | Basel | 4002 | Switzerland |
| Istanbul University Istanbul School of Medicine; Neurology | Istanbul | 34093 | Turkey (Türkiye) |
| Dokuz Eylul University Medicine Faculty; Noroloji Departmani | Izmir | 35340 | Turkey (Türkiye) |
| Ondokuz Mayis University School of Medicine; Neurology | Samsun | 55139 | Turkey (Türkiye) |
| Llandough Hospital; Llandough Hospital Memory Team 3rd Floor Academic Building | Cardiff | CF64 2XX | United Kingdom |
| Imperial Memory Unit, Charing Cross Hospital; Level 10 West, Department of Neurosciences | London | W6 8RF | United Kingdom |
| Campus for Ageing & Vitality; Clincal Ageing Research Unit | Newcastle | NE4 5PL | United Kingdom |
| Hollins Park Hospital | Warrington | WA2 8WA | United Kingdom |
Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks. |
| Safety Evaluable Population | Safety evaluable population included all the participants who received at least one dose of gantenerumab |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent to treat (ITT) population included all the participants who were enrolled in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SCarlet RoAD | Participants enrolled from the open label extension (OLE) part of parent study WN25203, received gantenerumab, up to 1200 milligram (mg), subcutaneous (SC) injection, every 4 weeks (Q4W) for up to 129 weeks. |
| BG001 | Marguerite RoAD | Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks. |
| BG002 | Total | Total of all reporting groups |
| 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 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was defined as any untoward medical occurrence in a participant administered with gantenerumab and which does not necessarily have a causal relationship with gantenerumab. A Serious Adverse Event (SAE) is any significant hazard, contraindication, side effect that is fatal or life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above, and which does not necessarily have a causal relationship with gantenerumab. | Safety evaluable population included all the participants who received at least one dose of gantenerumab. | Posted | Count of Participants | Participants | Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Change in Any Suicidal Ideation or Behavior as Assessed by 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= no suicide risk present. Score of 1 or higher= suicidal ideation/behavior. Number of participants with any suicidal ideation/behavior were reported. | Safety evaluable population included all the participants who received at least one dose of gantenerumab. Overall number analyzed is the number of participants with data available for analysis. | Posted | Count of Participants | Participants | Baseline (Day 1), up to Week 104 |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) AEs | Safety evaluable population included all the participants who received at least one dose of gantenerumab. | Posted | Count of Participants | Participants | Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) AEs | Safety evaluable population included all the participants who received at least one dose of gantenerumab. | Posted | Count of Participants | Participants | Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Anti-drug Antibody (ADA) to Gantenerumab | Safety evaluable population included all the participants who received at least one dose of gantenerumab. | Posted | Count of Participants | Participants | Up to Week 133 |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Injection-Site Reactions | Safety evaluable population included all the participants who received at least one dose of gantenerumab. | Posted | Count of Participants | Participants | Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Discontinued Treatment Due to AEs | An AE was defined as any untoward medical occurrence in a participant administered with gantenerumab and which does not necessarily have a causal relationship with gantenerumab. SAE is any significant hazard, contraindication, side effect that is fatal or life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above, and which does not necessarily have a causal relationship with gantenerumab. | Safety evaluable population included all the participants who received at least one dose of gantenerumab. | Posted | Count of Participants | Participants | Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) |
|
Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Safety evaluable population included all the participants who received at least one dose of gantenerumab.
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 | SCarlet RoAD | Participants enrolled from the OLE part of parent study WN25203, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks. | 2 | 59 | 11 | 59 | 43 | 59 |
| EG001 | Marguerite RoAD | Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks. | 0 | 56 | 10 | 56 | 39 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Acute abdomen | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.1 | Systematic Assessment |
| |
| Breast cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.1 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.1 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Neuropsychiatric symptoms | Psychiatric disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
| |
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 25.1 | 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 |
| Dec 21, 2023 |
| Prot_SAP_000.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
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Marguerite RoAD | Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks. |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|