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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000766-42 | EudraCT Number |
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Decision to terminate development of Gantenerumab for treatment of prodromal/mild/early-stage Alzheimer's disease following results of a pre-planned analysis of the safety and efficacy of Gant in Graduate I&II (WN29922/WN39658).
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This is an open-label, multicenter, rollover study to evaluate the safety, tolerability, and efficacy of long-term administration of open-label gantenerumab in participants with AD who completed Study WN29922 or WN39658, either the double-blind or open-label extension (OLE) part.
Participants who were in the active arm in the double blind part and those who have completed OLE part in the parent study, will continue receive open-label gantenerumab 510 mg sub-cutaneously (SC) every 2 weeks (Q2W). Participants who are naive to gantenerumab treatment will be required to undergo the 3 step uptitration scheme as in the parent study before receiving target dose of open label gantenerumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Participants, who completed the double-blind part and did not enter the OLE part of Study WN29922 or WN39658, will be enrolled and receive open-label gantenerumab approximately 2 weeks after the Week 116 visit of Study WN29922 or WN39658. This will be considered the OLE baseline visit (OLE Day 1). |
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| Group 2 | Experimental | Participants, who completed the double-blind part and the OLE part of Study WN29922 or WN39658, will be enrolled and receive open-label gantenerumab approximately 2 weeks after the OLE Week 34 visit or the final dose visit in the Study WN29922 or WN39658 OLE. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gantenerumab | Drug | Group 1 participants who were in the active arm in the double blind part in the parent study (WN29922 or WN39658), will continue to receive open-label gantenerumab 510 mg SC, Q2W. Participants who are naive to gantenerumab treatment will be required to undergo the 3 step uptitration scheme before receiving target dose of open label gantenerumab, 510 mg SC, Q2W. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Adverse Event (AE) and Serious Adverse Event (SAE) | An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of casual attribution. A SAE is any AE that is fatal, life threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug or a significant medical event in the investigator's judgment. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks) |
| Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) Score | C-SSRS= assesses lifetime suicidality of participant (at baseline) & any new instances of suicidality (since last visit). Structured interview prompts recollection of suicidal ideation (intensity of ideation, behavior, & attempts with actual/potential lethality). Categories have yes/no responses, 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/Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior= "yes" to any of listed categories. Score of 0= no suicide risk. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here. First dosing visit in OLE (first dosing in current study or OLE period of parent GRADUATE studies)=baseline (OLE Day 1). | From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks) |
| Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by MRI | ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. In ARIA-E, (E for oedema or effusion), oedema can be seen in different areas of the brain on MRI, representing fluid leakage into the brain parenchyma or sulcal spaces. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Over Time in Clinical Dementia Rating - Global Score (CDR-GS) | CDR was derived through semi-structured interview with the participant and an appropriate informant, and it rated impairment across six domains: memory, orientation, judgment, and problem solving, community affairs, home and hobbies, and personal care on a 5-point scale for which 0=normal, 0.5=very mild dementia, 1=mild dementia, 2=moderate dementia, and 3= severe dementia. The score range for the CDR-GS is from 0 to 3 and a high score on the CDR-GS would indicate a high disease severity. A negative change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). |
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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 Alzheimer?s Institute | Phoenix | Arizona | 85006 | United States | ||
| Barrow Neurological Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39556389 | Derived | Salloway S, Wojtowicz J, Voyle N, Lane CA, Klein G, Lyons M, Rossomanno S, Mazzo F, Bullain S, Barkhof F, Bittner T, Schneider A, Grundman M, Aldea R, Boada M, Smith J, Doody R. Amyloid-Related Imaging Abnormalities (ARIA) in Clinical Trials of Gantenerumab in Early Alzheimer Disease. JAMA Neurol. 2025 Jan 1;82(1):19-29. doi: 10.1001/jamaneurol.2024.3937. |
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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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Participants who completed DB and OLE part received gantenerumab approximately 2 weeks after OLE Week 34 visit or final OLE dose visit in the parent study. Participants who completed DB part and did not enter the OLE part received gantenerumab approximately 2 weeks after the Week 116 visit of the parent study.
Participants took part in this study at 258 investigative centers across 28 countries from 26 January 2021 to 06 March 2023. A total of 1382 participants who completed either the double-blind (DB) part or open-label extension (OLE) part in parent GRADUATE studies WN29922 (NCT03444870) or WN39658 (NCT03443973) were enrolled in this study to receive open-label gantenerumab.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo: Participated in Graduate OLE | Participants treated with placebo in the DB part and who completed the DB and OLE up titration in study WN29922 (GRADUATE I) or WN39658 (GRADUATE II), continued receiving open-label gantenerumab, 510 milligrams (mg), SC, every two weeks (Q2W). |
| FG001 |
| 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 11, 2022 | Mar 4, 2024 |
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| Gantenerumab | Drug | Group 2 participants who have completed OLE part in the parent study (WN29922 or WN39658), will continue to receive open-label gantenerumab 510 mg SC, Q2W |
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| From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks) |
| Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) Confirmed by MRI | ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. ARIA-H (H for hemosiderosis) are small foci of signal loss observed on MRI sequences sensitive for paramagnetic tissue properties and comprise cerebral microbleeds (small foci of bleeding in the brain parenchyma) and leptomeningeal hemosiderosis (small foci of bleeding on the surface of the brain). These changes also occur sporadically in AD. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks) |
| Number of Participants With Injection-Site Reactions (ISRs) | An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product, regardless of casual attribution. Local injection reactions (or injection site reactions) are defined as AEs related to the injection site that occur during or within 24 hours after study drug administration that are judged to be related to the study drug injection. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks) |
| Number of Participants Who Discontinued the Study Due an AE | An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of casual attribution. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks) |
| Number of Participants With at Least One Adverse Event of Special Interest (AESI) | An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of casual attribution. AEs that were considered to be of special interest for this study included cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law and suspected transmission of an infectious agent by the study drug. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks) |
| Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104 |
| Change From Baseline Over Time in Clinical Dementia Rating (CDR) - Sum of Boxes (SB) | CDR was derived through semi-structured interview with the participant and an appropriate informant, and it rated impairment across six domains: memory, orientation, judgment, and problem solving, community affairs, home and hobbies, and personal care on a 5-point scale for which 0=no impairment, 0.5=questionable impairment, and 1, 2, and 3=mild, moderate, and severe impairment, respectively. The CDR-SB is based on summing each of the domain box scores with total score ranging from 0-18 with higher scores reflecting greater cognitive and functional impairment. A negative change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104 |
| Change From Baseline Over Time in Mini-Mental State Examination (MMSE) Score | MMSE is a rater-administered performance-based outcome (PerfO) that includes a set of standardized questions used to evaluate possible cognitive impairment and help stage the severity level of this impairment. The questions target six areas: orientation, registration, attention, short-term recall, language, and constructional praxis/visuospatial abilities. Total score ranges from 0-30, with lower scores indicating greater impairment. A positive change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104 |
| Change From Baseline Over Time in Alzheimer Disease Assessment Scale-Cognition, Subscale 11 (ADAS-Cog11) Score | ADAS-Cog11 was designed to measure cognitive symptom change in participants with Alzheimer's Disease (AD) and consisted of 11 tasks. The standard 11 items (and corresponding score range) were: word recall (0-10), commands (0-5), constructional praxis (0-5), naming objects and fingers (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), spoken language ability (0-5), comprehension of spoken language (0-5), word-finding difficulty (0-5), and remembering test instructions (0-5). The test included 7 performance items and 4 clinician-rated items. The ADAS-Cog11 total score was the sum of all 11 individual items, with a total score ranging from 0 (no impairment) to 70 (severe impairment). Higher scores indicated more severe cognitive impairment. A negative change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104 |
| Change From Baseline Over Time in Alzheimer Disease Assessment Scale-Cognition, Subscale 13 (ADAS-Cog13) Score | The ADAS-Cog13 total score includes all of the items in the ADAS-Cog11 in addition to delayed word recall and the number cancellation. For the ADAS-cog 13 the range is 0-85 (score range for Delayed Word Recall [DWR] score is 0-10 and for Number Cancellation [NC] is 0-5, thus the score is ADAS-cog 11[0-70] plus the scores for DWR and NC). A higher score indicates worse performance. A negative change from baseline indicates improvement in cognitive function. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104 |
| Change From Baseline Over Time in Verbal Fluency Task Score | VFT is a rater administered PerfO that measures speed and flexibility of verbal thought with a total score that ranges from 0-99 (lower scores indicating lower performance). A positive change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104 |
| Change From Baseline Over Time in Coding (Digit Symbol Substitution Test [DSST]) Subset | Coding, also called DSST is a rater administered PerfO that measures speed of processing and associative memory with a total score that ranges from 0-135 (lower scores indicating lower performance). The DSST was adapted from the Wechsler Adult Intelligence Scale. The 120-second version of the test was used in this study. Positive change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104 |
| Change in Functional Activities Questionnaire (FAQ) Score | FAQ is a rater-administered observer-reported outcome (ObsRO) (informant-based measure) that measures a participant's functional ability to perform complex higher-order activities. The observer provides performance ratings of the target person on ten complex higher-order activities. Total score that ranges from 0-30, with higher scores reflecting greater functional impairment. A negative change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104 |
| Change in Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) Score | ADCS-ADL is a 23-item rater-administered, ObsRO that captures a participant's ability to perform basic activities of daily living (e.g., eating and toileting) and more complex ADL or instrumental activities of daily living (iADL, e.g., using the telephone, managing finances, preparing a meal). Total score ranges from 0-78, with higher scores reflecting better functioning. A positive change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104 |
| Number of Participants With Anti-drug Antibody (ADA) to Gantenerumab | The number of participants with positive results for ADA against gantenerumab at any of the post-baseline assessment time-points were reported. Evaluable participant during OLE was participant with an ADA assay result from at least one sample during OLE. Treatment Emergent ADA = A participant with a negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks) |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Banner Sun Health Research Insitute | Sun City | Arizona | 85351 | United States |
| Health Initiatives Research, PLLC | Fayetteville | Arkansas | 72703 | United States |
| Fullerton Neurology and Headache Center | Fullerton | California | 92835 | United States |
| Neurology Center of North Orange County | Fullerton | California | 92835 | United States |
| Irvine Center for Clinical Research | Irvine | California | 92614 | United States |
| Desert Valley Research | Redlands | California | 92374 | United States |
| Sutter Medical Group, Neurology | Sacramento | California | 95816 | United States |
| Syrentis Clinical Research | Santa Ana | California | 92705 | United States |
| California Neuroscience Research Medical Group, Inc | Sherman Oaks | California | 91403 | United States |
| Southern California Research LLC | Simi Valley | California | 93065 | United States |
| Yale University School Of Medicine | New Haven | Connecticut | 06519 | United States |
| Research Center for Clinical Studies, Inc. | Norwalk | Connecticut | 06851 | United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| JEM Research LLC | Atlantis | Florida | 33462 | United States |
| Accel Research Sites - CRU Tampa | Bradenton | Florida | 34201 | United States |
| Bradenton Research Center | Bradenton | Florida | 34205 | United States |
| Brain Matters Research, Inc. | Delray Beach | Florida | 33445 | United States |
| ClinCloud, LLC | Maitland | Florida | 32751 | United States |
| Optimus U Corp | Miami | Florida | 33125 | United States |
| Allied Biomedical Research Institute, Inc | Miami | Florida | 33155 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| Intercoastal Medical Group | Sarasota | Florida | 34239 | United States |
| Infinity Clinical Research, LLC | Sunrise | Florida | 33351 | United States |
| Axiom Clinical Research of Florida | Tampa | Florida | 33609 | United States |
| Alzheimer?s Research and Treatment Center | Wellington | Florida | 33414 | United States |
| Emory University | Atlanta | Georgia | 30329 | United States |
| Center for Advanced Research & Education | Gainesville | Georgia | 30501 | United States |
| Southern Illinois University, School of Medicine | Springfield | Illinois | 62702 | United States |
| American Health Network Institute, LLC | Avon | Indiana | 46123 | United States |
| Fort Wayne Neurological Center | Fort Wayne | Indiana | 46805 | United States |
| Via Christi Research | Wichita | Kansas | 67214 | United States |
| Brigham and Womens Hospital; Center for Alzheimer Research & Treatment | Boston | Massachusetts | 02115 | United States |
| Boston Center for Memory | Newton | Massachusetts | 02459 | United States |
| Precise Research Centers | Flowood | Mississippi | 39232 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Missouri Memory Center | Bolivar | Missouri | 65613 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center; Dept of Neurological Sciences | Omaha | Nebraska | 68198-8440 | United States |
| Cleveland Clinic Lou Ruvo; Center for Brain Research | Las Vegas | Nevada | 89106 | United States |
| The Cognitive and Research Center of New Jersey | Springfield | New Jersey | 07081 | United States |
| Advanced Memory Research Institute of NJ | Toms River | New Jersey | 08755 | United States |
| Neurological Associates of Long Island, PC | Lake Success | New York | 11042 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| AD-CARE, University of Rochester Medical Center | Rochester | New York | 14620 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10314 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Behavioral Health Research | Charlotte | North Carolina | 28211 | United States |
| Alzheimer's Memory Center | Matthews | North Carolina | 28105 | United States |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607-6520 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic; Cleveland Lou Ruvo Center for Brain Health ? Neurological Institute | Cleveland | Ohio | 44195 | United States |
| Ohio State University; College of Medicine | Columbus | Ohio | 43210 | United States |
| Summit Research Network Inc. | Portland | Oregon | 97210 | United States |
| Abington Neurological Associates | Abington | Pennsylvania | 19001 | United States |
| The Clinical Trial Center, LLC | Jenkintown | Pennsylvania | 19046 | United States |
| Senior Adults Specialty Research | Austin | Texas | 78757 | United States |
| Kerwin Medical Center | Dallas | Texas | 75231 | United States |
| Neurology Consultants of Dallas; Research Department | Dallas | Texas | 75243 | United States |
| Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine | Houston | Texas | 77030 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77054 | United States |
| Wasatch Clinical Research, LLC | Salt Lake City | Utah | 84107 | United States |
| University of Virginia | Charlottesville | Virginia | 22906 | United States |
| Sentara Neurology Specialists | Norfolk | Virginia | 23507 | United States |
| National Clinical Research Inc.-Richmond | Richmond | Virginia | 23294 | United States |
| UW Wisconsin-Madison | Madison | Wisconsin | 53705 | United States |
| Hospital Italiano | CABA | C1199ABB | Argentina |
| Universidad Maimonides | Caba | C1405BCK | Argentina |
| Instituto Geriatrico Nuestra Señora de las Nieves | Capital Federal | C1427CCP | Argentina |
| Instituto Kremer | Córdoba | X5004AOA | Argentina |
| CEN Centro Especializado en Neurociencias | Córdoba | X5004FJF | Argentina |
| Instituto de Neurociencias San Agustín S.A. | La Plata | B1902AVF | Argentina |
| Fundación Scherbovsky; General Department | Mendoza | M5500AYB | Argentina |
| St Vincent's Hospital Sydney; Neurology | Darlinghurst | New South Wales | 2010 | Australia |
| Central Coast Neurosciences Research | Erina | New South Wales | 2250 | Australia |
| Southern Neurology | Kogarah | New South Wales | 2217 | 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 |
| AZ Sint Blasius (Dendermonde) | Dendermonde | 9200 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| Jessa Zkh (Campus Virga Jesse) | Hasselt | 3500 | Belgium |
| Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia | Curitiba | Paraná | 80810-040 | Brazil |
| Instituto de Neurologia de Curitiba | Curitiba | Paraná | 81210-310 | Brazil |
| Clinica Clinilive ltda | Maringá | Paraná | 87013-250 | Brazil |
| Hospital das Clinicas - UFRGS | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Hospital das Clinicas - FMUSP_X; Neurologia | São Paulo | São Paulo | 05403-000 | Brazil |
| The Medical Arts Health Research Group - West Vancouver | Vancouver | British Columbia | V7T 2Z3 | Canada |
| Parkwood Hospital; Geriatric Medicine | London | Ontario | N6C 5J1 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Baycrest Health Sciences | Toronto | Ontario | M6A 2E1 | Canada |
| Devonshire Clinical Research | Woodstock | Ontario | N4S 5P5 | Canada |
| Center for Diagnosis and Research on Alzheimer's disease | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Alpha Recherche Clinique | Québec | G3K 2P8 | Canada |
| Psicomed Estudios Médicos | Antofagasta | 1270244 | Chile |
| Biomedica Research Group | Santiago | 7500710 | Chile |
| Especialidades Medicas LYS | Santiago | 7560356 | Chile |
| Beijing Tian Tan Hospital,Capital Medical University | Beijing | 100071 | China |
| Aarhus Universitetshospital; Neurologisk Afd. F, Demensklinikken | Aarhus N | 8200 | Denmark |
| Rigshospitalet, Hukommelsesklinikken | København Ø | 2100 | Denmark |
| Svendborg Sygehus; Neurologisk afdeling N, Demensklinik Fyn | Svendborg | 5700 | Denmark |
| Terveystalo Ruoholahti | Helsinki | 00180 | Finland |
| Itä-Suomen yliopisto, Kuopion kampus | Kuopio | 70210 | Finland |
| CHU Amiens Hopital Sud; Neurologie | Amiens Cedex1 | 80054 | France |
| Hôpital Avicenne; Centre de Recherche Clinique | Bobigny | 93009 | France |
| Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502) | Bron | 69677 | France |
| CHU de la Timone - Hopital d Adultes; Service de Neurologie | Marseille | 13005 | France |
| Hôpital Lariboisière | Paris | 75010 | France |
| CHU Poitiers - Hopital La Miletrie | Poitiers | 86000 | France |
| CHU Strasbourg Hôpital Hautepierre | Strasbourg | 67098 | France |
| Gerontopole; Centre de Recherche clinique | Toulouse | 31059 | France |
| Hopital des Charpennes | Villeurbanne | 69100 | 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 |
| Universitätsklinikum Köln; Klinik und Poliklinik für Psychiatrie und Psychotherapie | Cologne | 50937 | Germany |
| PANAKEIA - Arzneimittelforschung Leipzig GmbH | Leipzig | 04275 | Germany |
| Universitätsmedizin derJohannes Gutenberg-Universität Mainz;Klinik für Psychiatrie und Psychotherapi | Mainz | 55131 | Germany |
| Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie | München | 81675 | Germany |
| Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie | Münster | 48149 | Germany |
| Universitätsklinikum Rostock Zentrum für Nervenheilkunde | Rostock | 18147 | Germany |
| Universitätsklinikum Ulm; Klinik für Neurologie | Ulm | 89081 | Germany |
| Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz | Westerstede | 26655 | Germany |
| Forschungszentrum Ruhr | Witten | 58455 | 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 |
| Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica | Rome | Lazio | 00179 | Italy |
| Umberto I Policlinico di Roma-Università di Roma La Sapienza | Rome | Lazio | 00185 | Italy |
| Ospedale San Giovanni Calibita Fatebenefratell;Neurologia | Rome | Lazio | 00186 | Italy |
| IRCCS ?Centro S. Giovanni di Dio? Fatebenefratelli -UO Alzheimer | Brescia | Lombardy | 25125 | Italy |
| IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria | Milan | Lombardy | 20132 | Italy |
| ASST DI MONZA; Neurologia | Monza | Lombardy | 20900 | Italy |
| IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA | Pozzilli | Molise | 86077 | Italy |
| AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria | Turin | Piedmont | 10126 | Italy |
| Dipartimento delle Patologie Emergenti; Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone | Palermo | Sicily | 90127 | Italy |
| Yachiyo Hospital | Aichi | 446-8510 | Japan |
| Nagoya Ekisaikai Hospital | Aichi | 454-8502 | Japan |
| National Center for Geriatrics and Gerontology | Aichi | 474-8511 | Japan |
| Medical Corporation Hakuyokai Kashiwado Hospital | Chiba | 260-8656 | Japan |
| Tokyo Bay Advanced Medical and Makuhari Clinic | Chiba | 261-0024 | Japan |
| Inage Neurology and Memory Clinic | Chiba | 263-0043 | Japan |
| Juntendo University Urayasu Hospital | Chiba | 279-0021 | Japan |
| Fukuoka University Hospital | Fukuoka | 814-0180 | Japan |
| Southern Tohoku Medical Clinic | Fukushima | 963-8052 | Japan |
| National Hospital Organization Hiroshima-Nishi Medical Center | Hiroshima | 739-0696 | Japan |
| Kobe University Hospital | Hyōgo | 650-0017 | Japan |
| Hyogo Prefectural HarimaHimeji General Medical Center | Hyōgo | 670-8560 | Japan |
| Tsukazaki Hospital | Hyōgo | 671-1227 | Japan |
| Matsui Dietary and Dementia Clinic | Hyōgo | 673-0891 | Japan |
| Kagawa Prefectural Central Hospital | Kagawa | 760-8557 | Japan |
| Shonan Kamakura General Hospital | Kanagawa | 247-8533 | Japan |
| Rakuwakai Otowa Hospital | Kyoto | 607-8062 | Japan |
| Uji Takeda Hospital | Kyoto | 611-0021 | Japan |
| Okayama Kyokuto Hospital | Okayama | 703-8265 | Japan |
| Rijikai Medical Corporation Katayama Medical Clinic | Okayama | 710-0813 | Japan |
| MI Clinic | Osaka | 560-0004 | Japan |
| Kishiwada Tokushukai Hospital | Osaka | 596-0042 | Japan |
| National Hospital Organization Hizen Psychiatric Medical Center | Saga | 842-0192 | Japan |
| NHO Shizuoka Institute of Epilepsy and Neurological Disorders | Shizuoka | 420-8688 | Japan |
| Shizuoka City Shimizu Hospital | Shizuoka | 424-0911 | Japan |
| Jichiidai Station Brain Clinic | Tochigi | 329-0403 | Japan |
| Medical corporation Ichiekai Itsuki Hospital | Tokushima | 770-0852 | Japan |
| Tokushima Hospital | Tokushima | 776-8585 | Japan |
| Tokyo Medical and Dental University Hospital | Tokyo | 113-8519 | Japan |
| Tokyo Medical University Hospital | Tokyo | 160-0023 | Japan |
| Nozomi Memory Clinic | Tokyo | 181-0013 | Japan |
| National Center of Neurology and Psychiatry | Tokyo | 187-8551 | Japan |
| P-One Clinic | Tokyo | 192-0071 | Japan |
| Yamagata Tokusyukai Hospital | Yamagata | 990-0834 | Japan |
| Vilnius University Hospital Santariskiu Clinics; Neurology | Vilnius | 08661 | Lithuania |
| Mexico Centre for Clinical Research | Mexico City | Mexico CITY (federal District) | 03100 | Mexico |
| Hospital Universitario Dr Jose Eleuterio Gonzalez UANL; Depto.de NeurologíaPta.BajaConsulta | Monterrey | Nuevo León | 64460 | Mexico |
| AVIX Investigación Clínica S.C | Monterrey | Nuevo León | 64710 | Mexico |
| Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC | Culiacán | Sinaloa | 80020 | Mexico |
| Brain Research Center B.V | Amsterdam | 1081 GN | Netherlands |
| Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion | Bellavista | Callao 2 | Peru |
| Clinica Internacional; Unidad De Investigacion | Lima | 15001 | Peru |
| Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia | Lima | 15003 | Peru |
| O?rodek Badawczo-Naukowo-Dydaktyczny Chorób Ot?piennych w ?cinawie | ?cinawa | 59-330 | Poland |
| Podlaskie Centrum Psychogeriatrii | Bia?ystok | 15-756 | Poland |
| NZOZ Vitamed | Bydgoszcz | 85-079 | Poland |
| NEURO-CARE Sp. z o.o. Sp. Komandytowa | Katowice | 40-749 | Poland |
| KO-MED Centra Kliniczne Lublin II | Lublin | 20-362 | Poland |
| Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych | Plewiska | 62-064 | Poland |
| Senior Sp. Z O.O. Poradnia Psychogeriatryczna | Sopot | 81-855 | Poland |
| mMED Maciej Czarnecki | Warsaw | 01-684 | Poland |
| Pratia S.A. | Warsaw | 02-171 | Poland |
| NZOZ WCA | Wroc?aw | 53-659 | Poland |
| Hospital de Braga; Servico de Neurologia | Braga | 4710-243 | Portugal |
| HUC; Servico de Neurologia | Coimbra | 3000-075 | Portugal |
| Hospital da Senhora da Oliveira-Guimarães; Serviço de Neurologia | Guimarães | Portugal |
| Hospital Geral de Santo Antonio; Servico de Neurologia | Porto | 4099-001 | Portugal |
| Santa Cruz Behavioral PSC | Bayamón | 00961 | Puerto Rico |
| University of Puerto Rico - Medical Science Campus; Internal Medicine | San Juan | 00936 | Puerto Rico |
| FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency | Krasnoyarsk | Krasnoyarsk Krai | 660037 | Russia |
| University ?linic of headaches | Moscow | Moscow Oblast | 121467 | Russia |
| City Clin Hosp n.a. S.P.Botkin | Moscow | Moscow Oblast | 125101 | Russia |
| City Polyclinic No. 2 of the Department of Healthcare of the City of Moscow | Moskva | Moscow Oblast | 117556 | Russia |
| FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF | Saint Petersburg | Sankt-Peterburg | 194044 | Russia |
| Vertebronevrologiya LLC | Kazan' | Tatarstan Republic | 420047 | Russia |
| State autonomous institution of healthcare Inter-regional clinical and diagnostic center | Kazan' | Tatarstan Republic | 420101 | Russia |
| MHI City Clinical Hospital #2 named after V.I. Razumovsky; Psychiatric | Saratov | 410028 | Russia |
| Nebbiolo Center for Clinical Trials | Tomsk | 634009 | Russia |
| Dong-A University Hospital | Busan | 49201 | South Korea |
| Myongji Hospital | Gyeonggi-do | 10475 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Inha University Hospital | Incheon | 22332 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 463-707 | South Korea |
| Hanyang University Seoul Hospital | Seoul | 04763 | South Korea |
| Konkuk University Medical Center | Seoul | 05030 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Seoul St Mary's Hospital | Seoul | 06591 | South Korea |
| Ewha Womans University Hospital (Seoul) | Seoul | 07804 | South Korea |
| Hospital General Universitario de Elche; Servicio de Neurología | Elche | Alicante | 03203 | Spain |
| Hospital Universitari de Bellvitge; Servicio de Neurologia | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital General De Catalunya; Servicio de Neurologia | Sant Cugat del Vallès | Barcelona | 8195 | Spain |
| Hospital Mutua De Terrasa; Servicio de Neurologia | Terrassa | Barcelona | 08222 | Spain |
| Hospital Virgen del Puerto. Servicio de Neurología | Plasencia | Caceres | 10600 | Spain |
| Hospital Universitario Marques de Valdecilla; Servicio de Neurología | Santander | Cantabria | 39011 | Spain |
| Policlínica Guipuzcoa; Servicio de Neurología | Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| Hospital San Pedro; Servicio de Neurología | Logroño | La Rioja | 26006 | Spain |
| Hospital Universitario de Santa Maria; Servicio de Neurología | Lleida | Lerida | 25198 | Spain |
| HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de Psiquiatría | Móstoles | Madrid | 28938 | Spain |
| Hospital Quiron de Madrid; Servicio de Neurologia | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Clinica Universitaria de Navarra; Servicio de Neurología | Pamplona | Navarre | 31008 | Spain |
| Clinica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| CAE OROITU; Servicio de Neurología | Getxo | Vizcaya | 48993 | Spain |
| Hospital General Universitario de Albacete; Servicio de Neurología | Albacete | Spain |
| Hospital del Mar; Servicio de Neurologia | Barcelona | 08003 | Spain |
| Fundación ACE; Servicio de Neurología | Barcelona | 08028 | Spain |
| Hospital Vall d'Hebron; Servicio de Neurología | Barcelona | 08035 | Spain |
| Hospital Clinic i Provincial; Servicio de Neurologia | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia | Barcelona | 08041 | Spain |
| Hospital Universitario Reina Sofia; Servicio de Neurologia | Córdoba | 14004 | Spain |
| Universitario de La Princesa; Servicio de Neurología | Madrid | 28006 | Spain |
| Hospital Ramon y Cajal; Servicio de Neurologia | Madrid | 28034 | Spain |
| Hospital Ruber Internacional; Servicio de Neurología | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Neurologia | Madrid | 28041 | Spain |
| Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría | Salamanca | 37005 | Spain |
| Hospital Virgen del Rocío; Servicio de Neurología | Seville | 41013 | Spain |
| Hospital Victoria Eugenia; Servico Neurología | Seville | Spain |
| Hospital Universitario Dr. Peset; Servicio de Neurologia | Valencia | 46017 | Spain |
| Hospital Universitario la Fe; Servicio de Neurologia | Valencia | 46026 | Spain |
| Complejo Asistencial de Zamora; Servicio Psiquiatria | Zamora | 49021 | Spain |
| Servicio de Neurología Hospital Viamed Montecanal. | Zaragoza | 50012 | Spain |
| Skånes Universitetssjukhus Malmö, Minneskliniken | Malmö | 211 46 | Sweden |
| Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry | Mölndal | 431 41 | Sweden |
| KAROLINSKA UNI HOSPITAL, HUDDINGE; Mottagning Kognitiv Forskning, M54 | Stockholm | 141 86 | Sweden |
| Changhua Christian Hospital; Neurology | Changhua County | 500 | Taiwan |
| Kaohsiung Medical University Hospital; Neurology | Kaohsiung City | 807 | Taiwan |
| Chang Gung Memorial Foundation - Kaohsiung - Neurology | Niaosong Dist. | 83301 | Taiwan |
| China Medical University Hospital; Neurology | North Dist. | 40447 | Taiwan |
| National Taiwan University Hospital; Neurology | Taipei | 100 | Taiwan |
| Chang Gung Memorial Foundation - Linkou - Neurology | Taoyuan | 333 | Taiwan |
| Ondokuz Mayis Univ. Med. Fac.; Neurology | Samsun | 55139 | Turkey (Türkiye) |
| The Rice Centre; Royal United Hospital | Bath | BA1 3NG | United Kingdom |
| Re:Cognition Health Birmingham | Birmingham | B16 8QQ | United Kingdom |
| The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre | Cheltenham | GL53 9DZ | United Kingdom |
| Surrey and Borders NHS Foundation Trust; Research and Development Department | Chertsey | KT16 9AU | United Kingdom |
| Ninewells Hospital | Dundee | DD12 9SY | United Kingdom |
| Queen Elizabeth University Hospital - PPDS | Glasgow | G51 4TF | United Kingdom |
| St George?s Hospital | London | SW17 ORE | United Kingdom |
| Re:Cognition Health London | London | W1G 9RU | United Kingdom |
| Charing Cross Hospital | London | W6 8RF | United Kingdom |
| Campus for Ageing and Vitality | Newcastle | NE4 5PL | United Kingdom |
| Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | S10 2JF | United Kingdom |
| University Southampton NHS Foundation Trust; Wessex Neurologica Centre | Southampton | SO166YD | United Kingdom |
| Placebo: No Participation in Graduate OLE |
Participants treated with placebo in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, every four weeks (Q4W) for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W for 3 doses before receiving open-label gantenerumab, 510 mg SC injections, Q2W. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo. |
| FG002 | Gantenerumab: Participated in Graduate OLE | Participants treated with gantenerumab in the DB part and who completed the DB and OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab, 510 mg, SC, Q2W. |
| FG003 | Gantenerumab: No Participation in Graduate OLE | Participants treated with gantenerumab in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab 510 mg SC, Q2W. |
| Safety-evaluable (SE) Analysis Set | SE analysis set included all participants enrolled who received at least one dose of study drug in this study or in the OLE part of the parent studies (GRADUATE I or GRADUATE II). Six participants randomized to placebo arm during the double-blind treatment in the parent studies received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set. |
|
| Intent-to-Treat Analysis (ITT) Set | ITT analysis set included all enrolled participants who received at least one dose of study drug. Participants will be analyzed by the treatment they were randomized to in the parent studies (GRADUATE I or GRADUATE II). |
|
| Magnetic Resonance Imaging (MRI) SE (M-SE) Analysis Set | M-SE analysis set included all participants in the SE analysis set who had at least one post-baseline safety MRI scan. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
ITT analysis set included all enrolled participants, who received at least one dose of study drug. Participants were analyzed by the treatment they were randomized to in the parent studies (GRADUATE I or GRADUATE II).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo: Participated in Graduate OLE | Participants treated with placebo in the DB part and who completed the DB and OLE up titration in study WN29922 (GRADUATE I) or WN39658 (GRADUATE II), continued receiving open-label gantenerumab, 510 mg, SC, Q2W. |
| BG001 | Placebo: No Participation in Graduate OLE | Participants treated with placebo in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W for 3 doses before receiving open-label gantenerumab, 510 mg SC injections, Q2W. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo. |
| BG002 | Gantenerumab: Participated in Graduate OLE | Participants treated with gantenerumab in the DB part and who completed the DB and OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab, 510 mg, SC, Q2W. |
| BG003 | Gantenerumab: No Participation in Graduate OLE | Participants treated with gantenerumab in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab 510 mg SC, Q2W. |
| 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 | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 at Least One Adverse Event (AE) and Serious Adverse Event (SAE) | An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of casual attribution. A SAE is any AE that is fatal, life threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug or a significant medical event in the investigator's judgment. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | SE analysis set included all participants enrolled who received at least one dose of study drug in this study or in the OLE part of the parent studies (GRADUATE I or GRADUATE II). Six participants randomized to placebo arm during the double-blind treatment in the parent studies received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set. | Posted | Count of Participants | Participants | From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks) |
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| Primary | Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) Score | C-SSRS= assesses lifetime suicidality of participant (at baseline) & any new instances of suicidality (since last visit). Structured interview prompts recollection of suicidal ideation (intensity of ideation, behavior, & attempts with actual/potential lethality). Categories have yes/no responses, 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/Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior= "yes" to any of listed categories. Score of 0= no suicide risk. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here. First dosing visit in OLE (first dosing in current study or OLE period of parent GRADUATE studies)=baseline (OLE Day 1). | SE analysis set included all participants enrolled who received at least one dose of study drug in this study or in the OLE part of the parent studies. Six participants randomized to placebo arm during the double-blind treatment in the parent studies received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set. Overall number analyzed is the number of participants with data available for analyses. | Posted | Count of Participants | Participants | From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks) |
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| Primary | Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by MRI | ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. In ARIA-E, (E for oedema or effusion), oedema can be seen in different areas of the brain on MRI, representing fluid leakage into the brain parenchyma or sulcal spaces. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | M-SE analysis set included all participants in the SE analysis set who had at least one post-baseline safety MRI scan. | Posted | Count of Participants | Participants | From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks) |
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| Primary | Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) Confirmed by MRI | ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. ARIA-H (H for hemosiderosis) are small foci of signal loss observed on MRI sequences sensitive for paramagnetic tissue properties and comprise cerebral microbleeds (small foci of bleeding in the brain parenchyma) and leptomeningeal hemosiderosis (small foci of bleeding on the surface of the brain). These changes also occur sporadically in AD. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | M-SE analysis set included participants in the SE analysis set who had at least one post-baseline safety MRI scan. | Posted | Count of Participants | Participants | From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks) |
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| Primary | Number of Participants With Injection-Site Reactions (ISRs) | An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product, regardless of casual attribution. Local injection reactions (or injection site reactions) are defined as AEs related to the injection site that occur during or within 24 hours after study drug administration that are judged to be related to the study drug injection. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | SE analysis set included all participants enrolled who received at least one dose of study drug in this study or in the OLE part of the parent studies (GRADUATE I or GRADUATE II). Six participants randomized to placebo arm during the double-blind treatment in the parent studies received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set. | Posted | Count of Participants | Participants | From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks) |
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| Primary | Number of Participants Who Discontinued the Study Due an AE | An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of casual attribution. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | SE analysis set included all participants enrolled who received at least one dose of study drug in this study or in the OLE part of the parent studies (GRADUATE I or GRADUATE II). Six participants randomized to placebo arm during the double-blind treatment in the parent studies received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set. | Posted | Count of Participants | Participants | From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks) |
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| Primary | Number of Participants With at Least One Adverse Event of Special Interest (AESI) | An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of casual attribution. AEs that were considered to be of special interest for this study included cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law and suspected transmission of an infectious agent by the study drug. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | SE analysis set included all participants enrolled who received at least one dose of study drug in this study or in the OLE part of the parent studies (GRADUATE I or GRADUATE II). Six participants randomized to placebo arm during the double-blind treatment in the parent studies received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set. | Posted | Count of Participants | Participants | From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks) |
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| Secondary | Change From Baseline Over Time in Clinical Dementia Rating - Global Score (CDR-GS) | CDR was derived through semi-structured interview with the participant and an appropriate informant, and it rated impairment across six domains: memory, orientation, judgment, and problem solving, community affairs, home and hobbies, and personal care on a 5-point scale for which 0=normal, 0.5=very mild dementia, 1=mild dementia, 2=moderate dementia, and 3= severe dementia. The score range for the CDR-GS is from 0 to 3 and a high score on the CDR-GS would indicate a high disease severity. A negative change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | ITT analysis set included all enrolled participants, who received at least one dose of study drug. Participants will be analyzed by the treatment they were randomized to in the parent studies (GRADUATE I or GRADUATE II). Overall number analyzed is the number of participants with data available for analyses. The number of participants analyzed indicates the number of participants with data available for analyses at the specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104 |
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| Secondary | Change From Baseline Over Time in Clinical Dementia Rating (CDR) - Sum of Boxes (SB) | CDR was derived through semi-structured interview with the participant and an appropriate informant, and it rated impairment across six domains: memory, orientation, judgment, and problem solving, community affairs, home and hobbies, and personal care on a 5-point scale for which 0=no impairment, 0.5=questionable impairment, and 1, 2, and 3=mild, moderate, and severe impairment, respectively. The CDR-SB is based on summing each of the domain box scores with total score ranging from 0-18 with higher scores reflecting greater cognitive and functional impairment. A negative change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | ITT analysis set included all enrolled participants, who received at least one dose of study drug. Participants will be analyzed by the treatment they were randomized to in the parent studies (GRADUATE I or GRADUATE II). Overall number analyzed is the number of participants with data available for analyses. The number of participants analyzed indicates the number of participants with data available for analyses at the specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104 |
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| Secondary | Change From Baseline Over Time in Mini-Mental State Examination (MMSE) Score | MMSE is a rater-administered performance-based outcome (PerfO) that includes a set of standardized questions used to evaluate possible cognitive impairment and help stage the severity level of this impairment. The questions target six areas: orientation, registration, attention, short-term recall, language, and constructional praxis/visuospatial abilities. Total score ranges from 0-30, with lower scores indicating greater impairment. A positive change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | ITT analysis set included all enrolled participants, who received at least one dose of study drug. Participants will be analyzed by the treatment they were randomized to in the parent studies (GRADUATE I or GRADUATE II). Overall number analyzed is the number of participants with data available for analyses. The number of participants analyzed indicates the number of participants with data available for analyses at the specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104 |
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| Secondary | Change From Baseline Over Time in Alzheimer Disease Assessment Scale-Cognition, Subscale 11 (ADAS-Cog11) Score | ADAS-Cog11 was designed to measure cognitive symptom change in participants with Alzheimer's Disease (AD) and consisted of 11 tasks. The standard 11 items (and corresponding score range) were: word recall (0-10), commands (0-5), constructional praxis (0-5), naming objects and fingers (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), spoken language ability (0-5), comprehension of spoken language (0-5), word-finding difficulty (0-5), and remembering test instructions (0-5). The test included 7 performance items and 4 clinician-rated items. The ADAS-Cog11 total score was the sum of all 11 individual items, with a total score ranging from 0 (no impairment) to 70 (severe impairment). Higher scores indicated more severe cognitive impairment. A negative change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | ITT analysis set included all enrolled participants, who received at least one dose of study drug. Participants will be analyzed by the treatment they were randomized to in the parent studies (GRADUATE I or GRADUATE II). Overall number analyzed is the number of participants with data available for analyses. The number of participants analyzed indicates the number of participants with data available for analyses at the specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104 |
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| Secondary | Change From Baseline Over Time in Alzheimer Disease Assessment Scale-Cognition, Subscale 13 (ADAS-Cog13) Score | The ADAS-Cog13 total score includes all of the items in the ADAS-Cog11 in addition to delayed word recall and the number cancellation. For the ADAS-cog 13 the range is 0-85 (score range for Delayed Word Recall [DWR] score is 0-10 and for Number Cancellation [NC] is 0-5, thus the score is ADAS-cog 11[0-70] plus the scores for DWR and NC). A higher score indicates worse performance. A negative change from baseline indicates improvement in cognitive function. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | ITT analysis set included all enrolled participants, who received at least one dose of study drug. Participants will be analyzed by the treatment they were randomized to in the parent studies (GRADUATE I or GRADUATE II). Overall number analyzed is the number of participants with data available for analyses. The number of participants analyzed indicates the number of participants with data available for analyses at the specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline Over Time in Verbal Fluency Task Score | VFT is a rater administered PerfO that measures speed and flexibility of verbal thought with a total score that ranges from 0-99 (lower scores indicating lower performance). A positive change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | ITT analysis set included all enrolled participants, who received at least one dose of study drug. Participants will be analyzed by the treatment they were randomized to in the parent studies (GRADUATE I or GRADUATE II). Overall number analyzed is the number of participants with data available for analyses. The number of participants analyzed indicates the number of participants with data available for analyses at the specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline Over Time in Coding (Digit Symbol Substitution Test [DSST]) Subset | Coding, also called DSST is a rater administered PerfO that measures speed of processing and associative memory with a total score that ranges from 0-135 (lower scores indicating lower performance). The DSST was adapted from the Wechsler Adult Intelligence Scale. The 120-second version of the test was used in this study. Positive change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | ITT analysis set included all enrolled participants, who received at least one dose of study drug. Participants will be analyzed by the treatment they were randomized to in the parent studies (GRADUATE I or GRADUATE II). Overall number analyzed is the number of participants with data available for analyses. The number of participants analyzed indicates the number of participants with data available for analyses at the specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Functional Activities Questionnaire (FAQ) Score | FAQ is a rater-administered observer-reported outcome (ObsRO) (informant-based measure) that measures a participant's functional ability to perform complex higher-order activities. The observer provides performance ratings of the target person on ten complex higher-order activities. Total score that ranges from 0-30, with higher scores reflecting greater functional impairment. A negative change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | ITT analysis set included all enrolled participants, who received at least one dose of study drug. Participants will be analyzed by the treatment they were randomized to in the parent studies (GRADUATE I or GRADUATE II). Overall number analyzed is the number of participants with data available for analyses. The number of participants analyzed indicates the number of participants with data available for analyses at the specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) Score | ADCS-ADL is a 23-item rater-administered, ObsRO that captures a participant's ability to perform basic activities of daily living (e.g., eating and toileting) and more complex ADL or instrumental activities of daily living (iADL, e.g., using the telephone, managing finances, preparing a meal). Total score ranges from 0-78, with higher scores reflecting better functioning. A positive change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | ITT analysis set included all enrolled participants, who received at least one dose of study drug. Participants will be analyzed by the treatment they were randomized to in the parent studies (GRADUATE I or GRADUATE II). Overall number analyzed is the number of participants with data available for analyses. The number of participants analyzed indicates the number of participants with data available for analyses at the specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104 |
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| Secondary | Number of Participants With Anti-drug Antibody (ADA) to Gantenerumab | The number of participants with positive results for ADA against gantenerumab at any of the post-baseline assessment time-points were reported. Evaluable participant during OLE was participant with an ADA assay result from at least one sample during OLE. Treatment Emergent ADA = A participant with a negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). | SE analysis set: all participants enrolled who received at least one dose of study drug in this study or in OLE part of parent studies (GRADUATE I or GRADUATE II). Six participants randomized to placebo arm during the double-blind treatment in the parent studies received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set. Overall number analyzed is the number of participants with an ADA assay result from any post-baseline sample. | Posted | Count of Participants | Participants | From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks) |
|
From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
All-cause mortality and Adverse events: SE analysis set. Six participants randomized to placebo arm during the double-blind treatment in the parent studies received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set. First dosing visit in OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo: Participated in Graduate OLE | Participants treated with placebo in the DB part and who completed the DB and OLE up titration in study WN29922 (GRADUATE I) or WN39658 (GRADUATE II), continued receiving open-label gantenerumab, 510 mg, SC, Q2W. | 0 | 14 | 2 | 14 | 13 | 14 |
| EG001 | Placebo: No Participation in Graduate OLE | Participants treated with placebo in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W for 3 doses before receiving open-label gantenerumab, 510 mg SC injections, Q2W. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo. | 5 | 691 | 72 | 691 | 395 | 691 |
| EG002 | Gantenerumab: Participated in Graduate OLE | Participants treated with gantenerumab in the DB part and who completed the DB and OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab, 510 mg, SC, Q2W. | 2 | 29 | 4 | 29 | 21 | 29 |
| EG003 | Gantenerumab: No Participation in Graduate OLE | Participants treated with gantenerumab in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab 510 mg SC, Q2W. | 4 | 647 | 54 | 647 | 358 | 647 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cor pulmonale acute | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Anal ulcer | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Fracture displacement | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Gastric leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Hepatobiliary neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Invasive breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Melanoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Amyloid related imaging abnormality-oedema/effusion | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dysstasia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Epileptic encephalopathy | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Motor dysfunction | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Subdural hygroma | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Thalamus haemorrhage | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Upper motor neurone lesion | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vasogenic cerebral oedema | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Delusion | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Peripheral artery aneurysm | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Bacteriuria | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Dacryocystitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Dermatophytosis of nail | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Vitamin B12 decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Amyloid related imaging abnormality-oedema/effusion | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Delusion | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Bladder irritation | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Stress urinary incontinence | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dermatosis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 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 | Nov 30, 2023 | Mar 4, 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
| 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 |
|
| SAEs |
|
Participants treated with placebo in the DB part and who completed the DB and OLE up titration in study WN29922 (GRADUATE I) or WN39658 (GRADUATE II), continued receiving open-label gantenerumab, 510 mg, SC, Q2W. |
| OG001 | Placebo: No Participation in Graduate OLE | Participants treated with placebo in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W for 3 doses before receiving open-label gantenerumab, 510 mg SC injections, Q2W. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo. |
| OG002 | Gantenerumab: Participated in Graduate OLE | Participants treated with gantenerumab in the DB part and who completed the DB and OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab, 510 mg, SC, Q2W. |
| OG003 | Gantenerumab: No Participation in Graduate OLE | Participants treated with gantenerumab in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab 510 mg SC, Q2W. |
|
|
| OG002 | Gantenerumab: Participated in Graduate OLE | Participants treated with gantenerumab in the DB part and who completed the DB and OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab, 510 mg, SC, Q2W. |
| OG003 | Gantenerumab: No Participation in Graduate OLE | Participants treated with gantenerumab in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab 510 mg SC, Q2W. |
|
|
| OG002 | Gantenerumab: Participated in Graduate OLE | Participants treated with gantenerumab in the DB part and who completed the DB and OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab, 510 mg, SC, Q2W. |
| OG003 | Gantenerumab: No Participation in Graduate OLE | Participants treated with gantenerumab in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab 510 mg SC, Q2W. |
|
|
Participants treated with placebo in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W for 3 doses before receiving open-label gantenerumab, 510 mg SC injections, Q2W. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo.
| OG002 | Gantenerumab: Participated in Graduate OLE | Participants treated with gantenerumab in the DB part and who completed the DB and OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab, 510 mg, SC, Q2W. |
| OG003 | Gantenerumab: No Participation in Graduate OLE | Participants treated with gantenerumab in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab 510 mg SC, Q2W. |
|
|
| OG002 | Gantenerumab: Participated in Graduate OLE | Participants treated with gantenerumab in the DB part and who completed the DB and OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab, 510 mg, SC, Q2W. |
| OG003 | Gantenerumab: No Participation in Graduate OLE | Participants treated with gantenerumab in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab 510 mg SC, Q2W. |
|
|
Participants treated with placebo in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W for 3 doses before receiving open-label gantenerumab, 510 mg SC injections, Q2W. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo. |
| OG002 | Gantenerumab: Participated in Graduate OLE | Participants treated with gantenerumab in the DB part and who completed the DB and OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab, 510 mg, SC, Q2W. |
| OG003 | Gantenerumab: No Participation in Graduate OLE | Participants treated with gantenerumab in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab 510 mg SC, Q2W. |
|
|
| OG001 |
| Placebo: No Participation in Graduate OLE |
Participants treated with placebo in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W for 3 doses before receiving open-label gantenerumab, 510 mg SC injections, Q2W. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo. |
| OG002 | Gantenerumab: Participated in Graduate OLE | Participants treated with gantenerumab in the DB part and who completed the DB and OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab, 510 mg, SC, Q2W. |
| OG003 | Gantenerumab: No Participation in Graduate OLE | Participants treated with gantenerumab in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab 510 mg SC, Q2W. |
|
|
| OG001 | Placebo: No Participation in Graduate OLE | Participants treated with placebo in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W for 3 doses before receiving open-label gantenerumab, 510 mg SC injections, Q2W. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo. |
| OG002 | Gantenerumab: Participated in Graduate OLE | Participants treated with gantenerumab in the DB part and who completed the DB and OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab, 510 mg, SC, Q2W. |
| OG003 | Gantenerumab: No Participation in Graduate OLE | Participants treated with gantenerumab in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab 510 mg SC, Q2W. |
|
|
| Placebo: No Participation in Graduate OLE |
Participants treated with placebo in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W for 3 doses before receiving open-label gantenerumab, 510 mg SC injections, Q2W. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo. |
| OG002 | Gantenerumab: Participated in Graduate OLE | Participants treated with gantenerumab in the DB part and who completed the DB and OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab, 510 mg, SC, Q2W. |
| OG003 | Gantenerumab: No Participation in Graduate OLE | Participants treated with gantenerumab in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab 510 mg SC, Q2W. |
|
|
Participants treated with placebo in the DB part and who completed the DB and OLE up titration in study WN29922 (GRADUATE I) or WN39658 (GRADUATE II), continued receiving open-label gantenerumab, 510 mg, SC, Q2W.
| OG001 | Placebo: No Participation in Graduate OLE | Participants treated with placebo in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W for 3 doses before receiving open-label gantenerumab, 510 mg SC injections, Q2W. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo. |
| OG002 | Gantenerumab: Participated in Graduate OLE | Participants treated with gantenerumab in the DB part and who completed the DB and OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab, 510 mg, SC, Q2W. |
| OG003 | Gantenerumab: No Participation in Graduate OLE | Participants treated with gantenerumab in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab 510 mg SC, Q2W. |
|
|
| Placebo: No Participation in Graduate OLE |
Participants treated with placebo in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W for 3 doses before receiving open-label gantenerumab, 510 mg SC injections, Q2W. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo. |
| OG002 | Gantenerumab: Participated in Graduate OLE | Participants treated with gantenerumab in the DB part and who completed the DB and OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab, 510 mg, SC, Q2W. |
| OG003 | Gantenerumab: No Participation in Graduate OLE | Participants treated with gantenerumab in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab 510 mg SC, Q2W. |
|
|
| OG002 | Gantenerumab: Participated in Graduate OLE | Participants treated with gantenerumab in the DB part and who completed the DB and OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab, 510 mg, SC, Q2W. |
| OG003 | Gantenerumab: No Participation in Graduate OLE | Participants treated with gantenerumab in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab 510 mg SC, Q2W. |
|
|
Participants treated with placebo in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W for 3 doses before receiving open-label gantenerumab, 510 mg SC injections, Q2W. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo.
| OG002 | Gantenerumab: Participated in Graduate OLE | Participants treated with gantenerumab in the DB part and who completed the DB and OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab, 510 mg, SC, Q2W. |
| OG003 | Gantenerumab: No Participation in Graduate OLE | Participants treated with gantenerumab in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab 510 mg SC, Q2W. |
|
|
Participants treated with placebo in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W for 3 doses before receiving open-label gantenerumab, 510 mg SC injections, Q2W. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo. |
| OG002 | Gantenerumab: Participated in Graduate OLE | Participants treated with gantenerumab in the DB part and who completed the DB and OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab, 510 mg, SC, Q2W. |
| OG003 | Gantenerumab: No Participation in Graduate OLE | Participants treated with gantenerumab in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab 510 mg SC, Q2W. |
|
|
Participants treated with placebo in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W for 3 doses before receiving open-label gantenerumab, 510 mg SC injections, Q2W. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo. |
| OG002 | Gantenerumab: Participated in Graduate OLE | Participants treated with gantenerumab in the DB part and who completed the DB and OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab, 510 mg, SC, Q2W. |
| OG003 | Gantenerumab: No Participation in Graduate OLE | Participants treated with gantenerumab in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab 510 mg SC, Q2W. |
|
|
Participants treated with placebo in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W for 3 doses before receiving open-label gantenerumab, 510 mg SC injections, Q2W. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo. |
| OG002 | Gantenerumab: Participated in Graduate OLE | Participants treated with gantenerumab in the DB part and who completed the DB and OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab, 510 mg, SC, Q2W. |
| OG003 | Gantenerumab: No Participation in Graduate OLE | Participants treated with gantenerumab in the DB part and who did not enter the OLE part of study WN29922 (GRADUATE I) or WN39658 (GRADUATE II) continued receiving open-label gantenerumab 510 mg SC, Q2W. |
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