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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003390-95 | EudraCT Number |
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Part 1 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab in participants with mild Alzheimer disease. Participants will be randomized to receive either gantenerumab subcutaneously every 4 weeks or placebo subcutaneously every 4 weeks. Approved Alzheimer medication is allowed if on stable dose for 3 months prior to screening. Part 2 is an open-label extension (OLE).
A positron emission tomography (PET) imaging substudy will be conducted within the main study. Eligible participants who provide separate informed consent will undergo PET imaging scans using the radioligand florbetapir as a pharmacodynamic measure of changes in brain amyloid load over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 (Double Blind treatment): Placebo | Placebo Comparator | Participants received matching placebo by subcutaneous (SC) injection every 4 weeks (Q4W) up to 100 weeks during Part 1 of the study. |
|
| Part 1 (Double Blind treatment): Gantenerumab | Experimental | Participants received 105 mg Gantenerumab by SC injection Q4W for 24 weeks and if eligible 225 mg SC injection Q4W from weeks 28-100 during Part 1 of the study. |
|
| Part 2 (Open-Label Extension [OLE] treatment): Placebo switched to Gantenerumab Up to 1200 mg | Placebo Comparator | Participants who had received Placebo in Part 1, received Gantenerumab at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years. |
|
| Part 2 (OLE treatment): Gantenerumab up to 1200 mg | Experimental | Participants who had received Gantenerumab in Part 1, received treatment at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Participants received Placebo SC injection Q4W. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 2: Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE 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. SAE is any adverse event that is fatal or which requires or prolongs inpatient hospitalization or results in persistent or significant disability/incapacity or causes congenital anomaly/birth defect or results in a significant medical event in the investigator's judgment. | First dose up to 4 weeks after the last dose of study drug (up to 249 weeks) |
| Part 2: Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) | 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 participants previously (in part 1) on Gantenerumab and Placebo. The prevalence of ADA at baseline was calculated as the percentage 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 percentage 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. | First dose up to last dose (Baseline up to until maximum 5 years) |
| Part 2: Percentage of Participants With Adverse Events Leading to Discontinuation of Treatment | Percentage of participants with adverse events leading to discontinuation from treatment were reported. | First dose up to 4 weeks after the last dose in OLE (Up to approximately 249 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Percentage of Participants With AEs, SAEs | An AE 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. A serious adverse event is any adverse event that is fatal or which requires or prolongs inpatient hospitalization or results in persistent or significant disability/incapacity or causes congenital anomaly/birth defect or results in a significant medical event in the investigator's judgment. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Mean Change From Baseline in Alzheimer's Disease Activity Scale-Cognitive Subscale 13 (ADAS-Cog13) Scores at Week 104 | Baseline, Week 104 | |
| Part 1: Mean Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Scores at Week 104 |
Inclusion Criteria:
PART 2 - All participants who have been randomized and are actively participating in the study are eligible for Part 2
Exclusion Criteria:
PET imaging substudy, in addition to above:
- Prior participation in other research study or clinical care within the last year such that the total radiation exposure would exceed the local or national annual limits
Part 2 Participants who have been discontinued from the study
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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 | ||
| Territory Neurology and Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39177596 | 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 |
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A total of 389 participants were enrolled out of which 387 were randomized and treated (192 received gantenerumab and 195 received placebo) in part 1 of the study. Of these, a total of 230 participants enrolled into Part 2 of the study: 225 participants received at least one dose of study drug. Participants who had discontinued from Part 1 of the study were not allowed to enroll in Part 2.
Part 1 of the study was conducted at 116 centers in 21 countries and part 2 was conducted at 75 centers in 17 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Placebo | Participants received matching placebo by subcutaneous (SC) injection every 4 weeks (Q4W) up to 100 weeks during Part 1 of study. |
| FG001 | Part 1: Gantenerumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1: Double Blind Treatment |
|
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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 | Feb 28, 2020 | Apr 8, 2022 |
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| Gantenerumab | Drug | Participants received Gantenerumab at 105 mg , 225 mg, or at doses up to 1200 mg SC injection Q4W. |
|
| First dose up to last dose (Up to approximately 152 weeks) |
| Part 1: Percentage of Participants With Treatment Emergent ADAs | 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 participants previously (in part 1) on Gantenerumab and Placebo. The prevalence of ADA at baseline was calculated as the percentage 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 percentage 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. | First dose up to last dose (Up to approximately 152 weeks) |
| Part 1: Gantenerumab Plasma Concentration at Multiple Timepoints | Pre-dose: Weeks 4, 8, 12, 24, 48, 72 and Post dose: Day 4 |
| Part 1: Percentage of Participants With Adverse Events Leading to Discontinuation of Treatment | Percentage of participants with adverse events leading to discontinuation from treatment were reported. | First dose up to last dose (Up to approximately 152 weeks) |
| Part 2: Percent Change From Baseline in Hippocampal Volume at Week 104 | Change from baseline in hippocampal right volume (HRV) and hippocampal left volume (HLV) were analyzed at Week 104 using magnetic resonance imaging. | Baseline (Part 1 screening), Week 104 |
| Part 2: Percent Change From Baseline in Whole Brain Volume at Week 104 | Change from baseline brain volume were analyzed at Week 104 using magnetic resonance imaging. | Baseline (Part 1 screening), Week 104 |
| Part 2: Percent Change From Baseline in Cortical Thickness at Week 104 | Change from baseline in cortical thickness were analyzed at Week 104 using magnetic resonance imaging. | Baseline (Part 1 screening), Week 104 |
| Part 2: Ventricular Volume as Measured by MRI at Week 104 | Ventricular volume were analyzed at Week 104 using magnetic resonance imaging. | Part 2: Week 104 |
| Part 2: Gantenerumab Plasma Concentration at Multiple Timepoints | Pre-dose: Weeks 104, 116, 156, 208; Post-dose: Weeks 53, 101 |
| Part 2: Change From Baseline in Brain Amyloid Load at Week 156 in a Subset of Participants | Brain amyloid load over time was assessed using a Florbetapir [F18] injection, a positron emission tomography (PET) radioligand selective to amyloid. Analysis was conducted in a subset of participants who signed consent to participate in the PET substudy. Amyloid PET burden was measured in a composite region of interest (ROI) by using standardized uptake value ratio (SUVR) mapped to the centiloid scale. The composite region was composed of the following six bilateral regions: frontal lobe, parietal lobe, temporal lobe, posterior cingulate cortex, anterior cingulate cortex. The reference region used to normalize the composite region was the cerebellar cortex. SUVR is ratio of tracer uptake in each of cingulate, frontal, parietal and temporal cortexes relative to cerebellum. The centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scans. | Baseline, Week 156 |
| Baseline, Week 104 |
| Part 1: Percentage Change From Baseline in Total Tau (T-tau) in CSF at Week 104 | Baseline, Week 104 |
| Part 1: Percentage Change From Baseline in Abeta 1-42 Levels in CSF at Week 104 | Baseline, Week 104 |
| Part 1: Percentage Change From Baseline in Phosphorylated Tau [P-tau] in CSF at Week 104 | Baseline, Week 104 |
| Part 1: Percent Change From Baseline in Hippocampal Volume at Week 104 | Baseline, Week 104 |
| Part 1: Percent Change From Baseline in Whole Brain Volume at Week 104 | Baseline, Week 104 |
| Part 1: Percent Change From Baseline in Cortical Thickness at Week 104 | Baseline, Week 104 |
| Part 1: Ventricular Volume as Measured by MRI at Week 104 | Baseline, Week 104 |
| Part 1: Change From Baseline in Clinical Dementia Rating Global Score (CDR-GS) at Week 104 | Baseline, Week 104 |
| Part 1: Change From Baseline in CDR Sum of Boxes (SB) at Week 104 | Baseline, Week 104 |
| Part 1: Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 104 | Baseline, Week 104 |
| Part 1: Change From Baseline in NPI Domain Score at Week 104 | Baseline, Week 104 |
| Part 1: Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Week 104 | Baseline, Week 104 |
| Part 1: Change From Baseline in Alzheimer's Dementia (QoL-AD) Global Score at Week 104 | Baseline, Week 104 |
| Part 1: Change From Baseline in Symptom Guide Facilitated (GAS) at Week 104 | Baseline, Week 104 |
| Part 1: Change From Baseline in Dependence Scale (DS) at Week 104 | Baseline, Week 104 |
| Part 1: Change From Baseline in Resource Utilization Dementia-Lite (RUD - Lite) Scale at Week 104 | Baseline, Week 104 |
| Part 1: Change From Baseline in Zarit Caregiver Interview for Alzheimer's Disease (ZCI-AD) at Week 104 | Baseline, Week 104 |
| Part 1: Time to Clinical Decline | Baseline up to Week 104 |
| Part 1: Change From Baseline in Clinical Composite Score (Prespecified Items From The ADAS-Cog, MMSE, and CDR) at Week 104 | Baseline, Week 104 |
| Part 1: Percentage of Participants With ADAS-Cog Response | Baseline up to Week 152 |
| Tucson |
| Arizona |
| 85704 |
| United States |
| ATP Clinical Research, Inc | Costa Mesa | California | 92626 | United States |
| Pacific Research Network - PRN | San Diego | California | 92103 | United States |
| California Neuroscience Research Medical Group, Inc | Sherman Oaks | California | 91403 | United States |
| Meridien Research | Brooksville | Florida | 34601 | United States |
| Brain Matters Research, Inc. | Delray Beach | Florida | 33445 | United States |
| Neuropsychiatric Research; Center of Southwest Florida | Fort Myers | Florida | 33912 | United States |
| Miami Jewish Health Systems; Clinical Research | Miami | Florida | 33137 | United States |
| Accelerated Enrollment Solutions | Orlando | Florida | 32806 | United States |
| University of South Florida | Tampa | Florida | 33613-4706 | United States |
| Alzheimer's Research and Treatment Center | Wellington | Florida | 33414 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| Louisiana Research Associates | New Orleans | Louisiana | 70114 | United States |
| Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research | Kalamazoo | Michigan | 49008 | United States |
| Millennium Psychiatric Associates, LLC | St Louis | Missouri | 63132 | United States |
| Alzheimer's Research Corporation | Paterson | New Jersey | 08759 | United States |
| Ocean Rheumatology | Toms River | New Jersey | 08775 | United States |
| Nathan Kline Institute | Orangeburg | New York | 10962 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| Alzheimer's Memory Center | Matthews | North Carolina | 28105 | United States |
| Richard H Weisler, MD | Raleigh | North Carolina | 27609 | United States |
| Central States Research | Tulsa | Oklahoma | 74136 | United States |
| Abington Neurological Associates | Abington | Pennsylvania | 19001 | United States |
| Northeastern Pennsylvania Memory | Plains | Pennsylvania | 18705 | United States |
| Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island | 02914 | United States |
| Neurology Clinic PC | Cordova | Tennessee | 38018 | United States |
| Senior Adults Specialty Research | Austin | Texas | 78757 | United States |
| University of Utah, Center for Alzheimer's Care Imaging & Research | Salt Lake City | Utah | 84108 | United States |
| Instituto Neurologia Bs As | Ciudad Autonoma Buenos Aires | C1426ANZ | Argentina |
| 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 |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Shat Np Sveti Naum; 3Rd Clinic of Neurology | Sofia | 1113 | Bulgaria |
| MBAL St. Marina; First Neurology Department | Varna | 9010 | Bulgaria |
| University of Calgary; Heritage Medical Research Clinic | Calgary | Alberta | T2N 4Z6 | Canada |
| True North Clinical Research-Halifax | Halifax | Nova Scotia | B3S 1N2 | Canada |
| True North Clinical Research | New Minas | Nova Scotia | B4N 3R7 | Canada |
| Jbn Medical Diagnostic Services Inc. | Burlington | Ontario | L7M 4Y1 | Canada |
| Parkwood Hospital; Geriatric Medicine | London | Ontario | N6C 5J1 | Canada |
| Kawartha Centre - Redefining Healthy Aging | Peterborough | Ontario | K9H 2P4 | Canada |
| Toronto Memory Program | Toronto | Ontario | M3B 2S7 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Recherches Neuro-Hippocame | Gatineau | Quebec | J8T 8J1 | Canada |
| NeuroSearch Developpements inc | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Jewish General Hospital / McGill University | Montreal | Quebec | H3T 1E2 | Canada |
| Centre Hospitalier Affilie Universitaire de Quebec - Hopital de L'Enfant Jesus | Québec | Quebec | G1J 1Z4 | Canada |
| McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric | Verdun | Quebec | H4H 1R3 | Canada |
| Alpha Recherche Clinique | Québec | G3K 2P8 | Canada |
| Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken | Aarhus N | 8200 | Denmark |
| Rigshospitalet, Hukommelsesklinikken | Koebenhavn Oe | 2100 | Denmark |
| University of Eastern Finland | Kuopio | 70210 | Finland |
| CRST Oy | Turku | 20520 | Finland |
| Hopital Pellegrin; Cmrr Aquitaine | Bordeaux | 33076 | France |
| Hopital Pierre Wertheimer; Laboratoire De Neuro Psychologie | Bron | 69677 | France |
| CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique | Limoges | 87042 | France |
| CHU de la Timone - Hopital d Adultes; Service de Neurologie | Marseille | 13005 | France |
| CHU Rennes - hopital Hotel Dieu; Consultation Memoire - Gerontologie | Rennes | 35064 | France |
| Hopital Hautepierre; Centre dInvestigation Clinique | Strasbourg | 67098 | France |
| Hopital la Grave; Gerontopole - Centre de Recherche Clinique | Toulouse | 31059 | France |
| ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic | Berlin | 13125 | Germany |
| PANAKEIA - Arzneimittelforschung Leipzig GmbH | Leipzig | 04275 | Germany |
| Pharmakologisches Studienzentrum | Mittweida | 09648 | Germany |
| Neurologische Praxis Dr. Andrej Pauls | München | 80331 | Germany |
| Klinikum rechts der Isar der TU München; Klinikapotheke | München | 81675 | Germany |
| Universitätsklinikum Ulm; Klinik für Neurologie | Ulm | 89081 | Germany |
| Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz | Westerstede | 26655 | Germany |
| Semmelweis University; Department of Neurology | Budapest | 1083 | Hungary |
| Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica - Dipartimento di Neuroscienze | Modena | Emilia-Romagna | 41126 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata; Neurologia | Rome | Lazio | 00133 | Italy |
| Umberto I Policlinico di Roma-Università di Roma La Sapienza | Rome | Lazio | 00185 | 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 |
| ASST DI MONZA; Neurologia | Monza | Lombardy | 20900 | Italy |
| A.O. Universitaria Pisana; Neurologia | Pisa | Tuscany | 56126 | Italy |
| Medical Corporation Hakuyokai Kashiwado Hospital | Chiba | 260-8656 | Japan |
| National Hospital Organization Chiba-east Hospital; Neurology | Chiba | 260-8712 | Japan |
| Juntendo University Urayasu Hospital; Neurology | Chiba | 279-0021 | Japan |
| Fukuoka University Hospital; Neurology and Health Care | Fukuoka | 814-0180 | Japan |
| Maebashi Red Cross Hospital; Neurology | Gunma | 371-0014 | Japan |
| National Hospital Organization Hiroshima-Nishi Medical Center | Hiroshima | 739-0696 | Japan |
| Hyogo Brain and Heart Center at Himeji; Department of Aging Brain and Cognitive Disorders | Hyōgo | 670-0981 | Japan |
| Shonan Kamakura General Hospital; Neurology | Kanagawa | 247-8533 | Japan |
| Kurashiki Heisei Hospital; Neurology | Okayama | 710-0826 | Japan |
| Oita University Hospital; Neurology | Ōita | 879-5593 | Japan |
| Shizuoka City Shimizu Hospital; Neurology | Shizuoka | 424-0911 | Japan |
| Brain Research Center B.V | Amsterdam | 1081 GN | Netherlands |
| Erasmus Mc - Locatie Centrum; Dept of Neurology | Rotterdam | 3015 GD | Netherlands |
| 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 Healthcare Institution "Republican Clinical Neurological Center | Kazan' | 420021 | Russia |
| State autonomous institution of healthcare Inter-regional clinical and diagnostic center | Kazan' | 420101 | Russia |
| Institution of RAMS (Mental Health Research Center of RAMS) | Moscow | 115522 | Russia |
| SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF | Moscow | 119021 | 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 |
| Dong-A University Medical Center | Busan | 602-715 | South Korea |
| Seoul National University Bundang Hospital; Neurology Department | Gyeonggi-do | 13620 | South Korea |
| Inha University Hospital; Neurology Department | Incheon | 22332 | South Korea |
| Konkuk University Medical Center | Seoul | 05030 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Ewha Womans University Hospital (Seoul) | Seoul | 07804 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | 137-701 | South Korea |
| Asan Medical Center. | Seoul | 138-736 | South Korea |
| Ewha Womans University Mokdong Hospital; Dept of Neurology | Seoul | 158-710 | South Korea |
| Hospital General Universitario de Elche; Servicio de Neurología | Elche | Alicante | 03203 | Spain |
| Fundació ACE | BArcelon | Barcelona | 08034 | Spain |
| Policlínica Guipuzkoa; Servicio de Neurología | Donosti-San Sebastián | Guipuzcoa | 20014 | Spain |
| Hospital de Cruces; Servicio de Neurologia | Barakaldo | Vizcaya | 48903 | Spain |
| Hospital del Mar; Servicio de Neurologia | Barcelona | 08003 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Neurologia | Madrid | 28041 | Spain |
| Hospital Universitario Virgen Macarena; Servicio de Neurologia | Seville | 41009 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| Skånes Universitetssjukhus Malmö, Minneskliniken | Malmö | 211 46 | Sweden |
| KAROLINSKA UNI HOSPITAL, HUDDINGE; Mottagning Kognitiv Forskning, M54 | Stockholm | 141 86 | Sweden |
| Felix Platter-Spital Medizin Geriatrie | Basel | 4002 | Switzerland |
| CHUV Lausanne Memory clinique | Lausanne | 1011 | 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) |
| Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit | Crowborough | TN6 1HB | United Kingdom |
| Glasgow Memory Clinic | Glasgow | G20 0XA | United Kingdom |
| Charing Cross Hospital; Dept of Neurosciences | London | W6 8RF | United Kingdom |
| Manchester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
| Royal Preston Hosptial | Preston | PR2 9HT | United Kingdom |
| Memory Service North | Sheffield | S35 8QS | United Kingdom |
| 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. |
Participants received 105 mg Gantenerumab by SC injection Q4W for 24 weeks and if eligible 225 mg SC injection Q4W from weeks 28-100 during Part 1 of the study.
| FG002 | Part 2 (OLE Treatment): Placebo Switched to Gantenerumab up to 1200 mg | Participants who had received Placebo in Part 1, received Gantenerumab at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years. |
| FG003 | Part 2 (OLE Treatment): Gantenerumab up to 1200 mg | Participants who had received Gantenerumab in Part 1, received treatment at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part 2: Open-label Extension |
|
|
The safety-evaluable population consisted of all participants who had received at least one dose of study drug, regardless of whether the participant withdrew prematurely or not.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Placebo | Participants received matching placebo by SC injection every 4 weeks Q4W up to 100 weeks during Part 1 of study. |
| BG001 | Part 1: Gantenerumab | Participants received 105 mg Gantenerumab by SC injection Q4W for 24 weeks and if eligible 225 mg SC injection Q4W from weeks 28-100 during Part 1 of the study. |
| BG002 | Part 2 (OLE Treatment): Placebo Switched to Gantenerumab up to 1200 mg | Participants who had received Placebo in Part 1, received Gantenerumab at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years. |
| BG003 | Part 2 (OLE Treatment): Gantenerumab up to 1200 mg | Participants who had received Gantenerumab in Part 1, received treatment at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years. |
| BG004 | 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 | Part 1 of the study. | Mean | Standard Deviation | years |
| |||||||||
| Age, Continuous | Part 2 of the study. | Mean | Standard Deviation | years |
| |||||||||
| Sex: Female, Male | Part 1 of the study. | Count of Participants | Participants |
| ||||||||||
| Sex: Female, Male | Part 2 of the study. | Count of Participants | Participants |
| ||||||||||
| Ethnicity (NIH/OMB) | Part 1 of the study. | Count of Participants | Participants |
| ||||||||||
| Ethnicity (NIH/OMB) | Part 2 of the study. | Count of Participants | Participants |
| ||||||||||
| Race (NIH/OMB) | Part 1 of the study. | Count of Participants | Participants |
| ||||||||||
| Race (NIH/OMB) | Part 2 of the study. | 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 | Part 2: Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE 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. SAE is any adverse event that is fatal or which requires or prolongs inpatient hospitalization or results in persistent or significant disability/incapacity or causes congenital anomaly/birth defect or results in a significant medical event in the investigator's judgment. | The safety-evaluable population consisted of all participants who had received at least one dose of study drug, regardless of whether the participant withdrew prematurely or not. | Posted | Number | Percentage of Participants | First dose up to 4 weeks after the last dose of study drug (up to 249 weeks) |
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|
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| Primary | Part 2: Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) | 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 participants previously (in part 1) on Gantenerumab and Placebo. The prevalence of ADA at baseline was calculated as the percentage 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 percentage 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 consisted of all participants who had received at least one dose of study drug, regardless of whether the participants withdrew prematurely or not. The number of participants analyzed indicates the number of participants evaluated for the outcome measure. | Posted | Number | Percentage of Participants | First dose up to last dose (Baseline up to until maximum 5 years) |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Part 2: Percentage of Participants With Adverse Events Leading to Discontinuation of Treatment | Percentage of participants with adverse events leading to discontinuation from treatment were reported. | The safety population consisted of all participants who had received at least one dose of study drug, regardless of whether the participants withdrew prematurely or not. | Posted | Number | Percentage of Participants | First dose up to 4 weeks after the last dose in OLE (Up to approximately 249 weeks) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part 1: Percentage of Participants With AEs, SAEs | An AE 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. A serious adverse event is any adverse event that is fatal or which requires or prolongs inpatient hospitalization or results in persistent or significant disability/incapacity or causes congenital anomaly/birth defect or results in a significant medical event in the investigator's judgment. | The safety population consisted of all participants who received at least one dose of study drug, regardless of whether the participants withdrew prematurely or not. | Posted | Number | Percentage of Participants | First dose up to last dose (Up to approximately 152 weeks) |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Part 1: Percentage of Participants With Treatment Emergent ADAs | 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 participants previously (in part 1) on Gantenerumab and Placebo. The prevalence of ADA at baseline was calculated as the percentage 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 percentage 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 consisted of all participants who received at least one dose of study drug, regardless of whether the participants withdrew prematurely or not. The number of participants analyzed indicates the number of participants evaluated for the outcome measure. | Posted | Number | Percentage of Participants | First dose up to last dose (Up to approximately 152 weeks) |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Part 1: Gantenerumab Plasma Concentration at Multiple Timepoints | The pharmacokinetic (PK) evaluable population consisted of all participants that were treated with gantenerumab and provided at least 1 post-baseline PK sample. Number analyzed is the number of participants with data available for analyses at the given time-point. | Posted | Mean | Standard Deviation | μg/mL | Pre-dose: Weeks 4, 8, 12, 24, 48, 72 and Post dose: Day 4 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part 1: Percentage of Participants With Adverse Events Leading to Discontinuation of Treatment | Percentage of participants with adverse events leading to discontinuation from treatment were reported. | The safety population consisted of all participants who received at least one dose of study drug, regardless of whether the participants withdrew prematurely or not. | Posted | Number | Percentage of Participants | First dose up to last dose (Up to approximately 152 weeks) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Percent Change From Baseline in Hippocampal Volume at Week 104 | Change from baseline in hippocampal right volume (HRV) and hippocampal left volume (HLV) were analyzed at Week 104 using magnetic resonance imaging. | The safety population consisted of all participants who received at least one dose of gantenerumab during the OLE and also had at least one post baseline MRI. The number of participants analyzed indicates the number of participants evaluated for the outcome measure. Number analyzed is the number of participants with data available for analyses at the given time-point. | Posted | Mean | Standard Deviation | Percent Change | Baseline (Part 1 screening), Week 104 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Percent Change From Baseline in Whole Brain Volume at Week 104 | Change from baseline brain volume were analyzed at Week 104 using magnetic resonance imaging. | The safety population consisted of all participants who received at least one dose of gantenerumab during the OLE and also had at least one post baseline MRI. The number of participants analyzed indicates the number of participants evaluated for the outcome measure. | Posted | Mean | Standard Deviation | Percent Change | Baseline (Part 1 screening), Week 104 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Percent Change From Baseline in Cortical Thickness at Week 104 | Change from baseline in cortical thickness were analyzed at Week 104 using magnetic resonance imaging. | The safety population consisted of all participants who received at least one dose of gantenerumab during the OLE and also had at least one post baseline MRI. The number of participants analyzed indicates the number of participants evaluated for the outcome measure. | Posted | Mean | Standard Deviation | Percent Change | Baseline (Part 1 screening), Week 104 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Ventricular Volume as Measured by MRI at Week 104 | Ventricular volume were analyzed at Week 104 using magnetic resonance imaging. | The safety population consisted of all participants who received at least one dose of gantenerumab during the OLE and also had at least one post baseline MRI. The number of participants analyzed indicates the number of participants evaluated for the outcome measure. | Posted | Mean | Standard Deviation | mL | Part 2: Week 104 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Gantenerumab Plasma Concentration at Multiple Timepoints | Of the 225 participants in the OLE safety evaluable population, evaluable PK information was available from 223 participants. The PK evaluable population consisted of all participants that were treated with gantenerumab and provided at least 1 post-baseline PK sample. Number analysed is the number of participants with data available for analyses at the given time-point. | Posted | Mean | Standard Deviation | μg/mL | Pre-dose: Weeks 104, 116, 156, 208; Post-dose: Weeks 53, 101 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Change From Baseline in Brain Amyloid Load at Week 156 in a Subset of Participants | Brain amyloid load over time was assessed using a Florbetapir [F18] injection, a positron emission tomography (PET) radioligand selective to amyloid. Analysis was conducted in a subset of participants who signed consent to participate in the PET substudy. Amyloid PET burden was measured in a composite region of interest (ROI) by using standardized uptake value ratio (SUVR) mapped to the centiloid scale. The composite region was composed of the following six bilateral regions: frontal lobe, parietal lobe, temporal lobe, posterior cingulate cortex, anterior cingulate cortex. The reference region used to normalize the composite region was the cerebellar cortex. SUVR is ratio of tracer uptake in each of cingulate, frontal, parietal and temporal cortexes relative to cerebellum. The centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scans. | The safety population consisted of all participants who had received at least one dose of study drug, regardless of whether the participants withdrew prematurely or not. The number of participants analysed indicates the number of participants evaluated for the outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 156 |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part 1: Mean Change From Baseline in Alzheimer's Disease Activity Scale-Cognitive Subscale 13 (ADAS-Cog13) Scores at Week 104 | Not Posted | Baseline, Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part 1: Mean Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Scores at Week 104 | Not Posted | Baseline, Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part 1: Percentage Change From Baseline in Total Tau (T-tau) in CSF at Week 104 | Not Posted | Baseline, Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part 1: Percentage Change From Baseline in Abeta 1-42 Levels in CSF at Week 104 | Not Posted | Baseline, Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part 1: Percentage Change From Baseline in Phosphorylated Tau [P-tau] in CSF at Week 104 | Not Posted | Baseline, Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part 1: Percent Change From Baseline in Hippocampal Volume at Week 104 | Not Posted | Baseline, Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part 1: Percent Change From Baseline in Whole Brain Volume at Week 104 | Not Posted | Baseline, Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part 1: Percent Change From Baseline in Cortical Thickness at Week 104 | Not Posted | Baseline, Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part 1: Ventricular Volume as Measured by MRI at Week 104 | Not Posted | Baseline, Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part 1: Change From Baseline in Clinical Dementia Rating Global Score (CDR-GS) at Week 104 | Not Posted | Baseline, Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part 1: Change From Baseline in CDR Sum of Boxes (SB) at Week 104 | Not Posted | Baseline, Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part 1: Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 104 | Not Posted | Baseline, Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part 1: Change From Baseline in NPI Domain Score at Week 104 | Not Posted | Baseline, Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part 1: Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Week 104 | Not Posted | Baseline, Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part 1: Change From Baseline in Alzheimer's Dementia (QoL-AD) Global Score at Week 104 | Not Posted | Baseline, Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part 1: Change From Baseline in Symptom Guide Facilitated (GAS) at Week 104 | Not Posted | Baseline, Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part 1: Change From Baseline in Dependence Scale (DS) at Week 104 | Not Posted | Baseline, Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part 1: Change From Baseline in Resource Utilization Dementia-Lite (RUD - Lite) Scale at Week 104 | Not Posted | Baseline, Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part 1: Change From Baseline in Zarit Caregiver Interview for Alzheimer's Disease (ZCI-AD) at Week 104 | Not Posted | Baseline, Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part 1: Time to Clinical Decline | Not Posted | Baseline up to Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part 1: Change From Baseline in Clinical Composite Score (Prespecified Items From The ADAS-Cog, MMSE, and CDR) at Week 104 | Not Posted | Baseline, Week 104 | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part 1: Percentage of Participants With ADAS-Cog Response | Not Posted | Baseline up to Week 152 | Participants |
Baseline up to 52 weeks after the last dose of study drug (up to 7 years)
The safety-evaluable population consisted of all participants who had received at least one dose of study drug, regardless of whether the participant withdrew prematurely or not.
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 | Part 1: Placebo | Participants received matching placebo by SC injection every 4 weeks Q4W up to 100 weeks during Part 1 of study. | 11 | 195 | 53 | 195 | 147 | 195 |
| EG001 | Part 1: Gantenerumab | Participants received 105 mg Gantenerumab by SC injection Q4W for 24 weeks and if eligible 225 mg SC injection Q4W from weeks 28-100 during Part 1 of the study. | 8 | 192 | 61 | 192 | 159 | 192 |
| EG002 | Part 2 (OLE Treatment): Placebo Switched to Gantenerumab up to 1200 mg | Participants who had received Placebo in Part 1, received Gantenerumab at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years. | 5 | 117 | 29 | 117 | 94 | 117 |
| EG003 | Part 2 (OLE Treatment): Gantenerumab up to 1200 mg | Participants who had received Gantenerumab in Part 1, received treatment at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years. | 5 | 108 | 41 | 108 | 91 | 108 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ocular hypertension | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Appendiceal abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Colonic abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Shunt infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Tonsillitis bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Chest injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Optic nerve injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Cerebellar tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Invasive lobular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Ovarian epithelial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of pharynx | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| ARIA-E | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ARIA-H | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Brain stem infarction | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cerebral haematoma | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cerebral venous sinus thrombosis | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dementia Alzheimer's type | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dementia of the Alzheimer's type, with delusions | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vertebral artery dissection | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vertebrobasilar stroke | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Affective disorder | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Psychotic symptom | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Suicide threat | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Aortic aneurysm rupture | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Giant cell arteritis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ARIA-E | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ARIA-H | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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As the participants transitioned early to OLE, most participants did not reach the primary analysis timepoint (Week 104). Hence, the efficacy endpoints for Part 1 became exploratory in nature.
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 | May 31, 2021 | Apr 8, 2022 | 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
| Death |
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| Lost to Follow-up |
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| Non-Compliance |
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| Withdrawal by Subject |
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| Study Terminated By Sponsor |
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| Physician Decision |
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| Other |
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| Part 2 (OLE Treatment): Gantenerumab up to 1200 mg |
Participants who had received Gantenerumab in Part 1, received treatment at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years. |
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| Participants |
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| Participants |
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| Units |
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| Participants |
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| Participants |
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| OG001 | Part 2 (OLE Treatment): Gantenerumab up to 1200 mg | Participants who had received Gantenerumab in Part 1, received treatment at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years. |
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