A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)

Phase 3

Terminated

• Conditions: Alzheimer Disease
• Interventions: Drug: Gantenerumab

• Registration Number: NCT04339413
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

The main purpose of the study was to evaluate the safety and tolerability of long-term administration of gantenerumab in participants with AD. All participants who have completed the open-label extensions (OLEs) of studies WN25203 or WN28745 were enrolled in Part 1 of this study. Of these, participants who completed Week 104 visit in Part 1. Participants rec...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-04-07
• Study First Posted: 2020-04-09
• Study Start: 2020-05-22
• Primary Completion: 2023-01-04
• Study Completion: 2023-01-04
• Status Verified: 2023-12
• Results First Submitted: 2023-12-21
• Results First Submitted QC: 2023-12-21
• Last Update Submitted: 2023-12-21
• Results First Posted: 2024-01-18
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Part 1: Participants who completed the open-label extensions (OLEs) of studies WN25203 or WN28745 will be eligible to participate in Part 1 of the study
• Part 2: All participants who have completed Week 104 visit in Part 1 will be eligible for Part 2 of the study
• For Part 1 and Part 2:
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 16 weeks after the last dose of study drug
• Agreement to not donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug
• Availability of a person ('caregiver') who in the investigator's judgement, has frequent and sufficient contact with the participant

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Exclusion Criteria

• Prematurely discontinued from the OLEs of studies WN25203 or WN28745 or from study drug for any reason
• Any medical condition that may jeopardize the participant's safety if he or she continues to receive study treatment
• If the participant is unlikely to benefit from gantenerumab therapy, based on disease progression or other factors, or if study participation is otherwise not in the participant's best interest
• Any investigational treatment other than gantenerumab during or since completion of the OLEs of studies WN25203 or WN28745
• Pregnancy
• Evidence of disseminated leptomeningeal hemosiderosis (i.e., more than three focal leptomeningeal hemosiderosis)
• Evidence of intracerebral macrohemorrhage
• Part 2: Participants who have been discontinued from Part 1 of the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Marguerite RoAD	Gantenerumab	Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks.
SCarlet RoAD	Gantenerumab	Participants enrolled from the open label extension (OLE) part of parent study WN25203, received gantenerumab, up to 1200 milligram (mg), subcutaneous (SC) injection, every 4 weeks (Q4W) for up to 129 weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Injection-Site Reactions	Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)	An AE was defined as any untoward medical occurrence in a participant administered with gantenerumab and which does not necessarily have a causal relationship with gantenerumab. A Serious Adverse Event (SAE) is any significant hazard, contraindication, side effect that is fatal or life threatening; requires in-patient hospitalization or prolongation of exist...
Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) AEs	Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Number of Participants With Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) AEs	Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Number of Participants With Anti-drug Antibody (ADA) to Gantenerumab	Up to Week 133
Number of Participants Who Discontinued Treatment Due to AEs	Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)	An AE was defined as any untoward medical occurrence in a participant administered with gantenerumab and which does not necessarily have a causal relationship with gantenerumab. SAE is any significant hazard, contraindication, side effect that is fatal or life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; resul...
Number of Participants With Change in Any Suicidal Ideation or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)	Baseline (Day 1), up to Week 104	C-SSRS=assessment tool used to assess lifetime suicidality of a participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, \& attempts with actual/potential lethality. Categories have binary responses (yes/no) \& in...

Trial Locations

Locations (56)

Instituto Neurologia Bs As; 🇦🇷 Ciudad Autonoma Buenos Aires, Argentina

Juntendo University Urayasu Hospital; Neurology; 🇯🇵 Chiba, Japan

NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek; 🇵🇱 Pozna?, Poland

Centrum Medyczne NeuroProtect; 🇵🇱 Warszawa, Poland

Saint Petersburg State Institution of Healthcare City Geriatric Medico-Social Center; 🇷🇺 Saint Petersburg, Sankt Petersburg, Russian Federation

Ondokuz Mayis University School of Medicine; Neurology; 🇹🇷 Samsun, Turkey

Toronto Memory Program; 🇨🇦 Toronto, Ontario, Canada

Richmond Behavioral Associates; 🇺🇸 Staten Island, New York, United States

Banner Sun Health Research Insitute; 🇺🇸 Sun City, Arizona, United States

Central States Research; 🇺🇸 Tulsa, Oklahoma, United States

Accelerated Enrollment Solutions; 🇺🇸 Orlando, Florida, United States

Bioclinica The Villages; 🇺🇸 The Villages, Florida, United States

Kawartha Centre - Redefining Healthy Aging; 🇨🇦 Peterborough, Ontario, Canada

Neurology Clinic PC; 🇺🇸 Cordova, Tennessee, United States

Alzheimer's Memory Center; 🇺🇸 Matthews, North Carolina, United States

Senior Adults Specialty Research; 🇺🇸 Austin, Texas, United States

Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre; 🇦🇺 Heidelberg West, Victoria, Australia

Centricity Research; 🇨🇦 Halifax, Nova Scotia, Canada

Irccs Multimedica Santa Maria; Unita' Di Neurologia; 🇮🇹 Castellanza, Lombardia, Italy

Especialidades Medicas LYS; 🇨🇱 Santiago, Chile

Hospital Universitario 12 de Octubre; Servicio de Neurologia; 🇪🇸 Madrid, Spain

Imperial Memory Unit, Charing Cross Hospital; Level 10 West, Department of Neurosciences; 🇬🇧 London, United Kingdom

Hollins Park Hospital; 🇬🇧 Warrington, United Kingdom

FSMEI HPE ?Military Medical Academy n.a. S.M.Kirov"of Minist; 🇷🇺 Sankt-peterburg, Sankt Petersburg, Russian Federation

Hospital del Mar; Servicio de Neurologia; 🇪🇸 Barcelona, Spain

Istanbul University Istanbul School of Medicine; Neurology; 🇹🇷 Istanbul, Turkey

Dokuz Eylul University Medicine Faculty; Noroloji Departmani; 🇹🇷 Izmir, Turkey

Hospital Universitario la Fe; Servicio de Neurologia; 🇪🇸 Valencia, Spain

Campus for Ageing & Vitality; Clincal Ageing Research Unit; 🇬🇧 Newcastle, United Kingdom

Hospital Universitario Dr. Peset; Servicio de Neurologia; 🇪🇸 Valencia, Spain

Hospital General Universitario de Elche; Servicio de Neurología; 🇪🇸 Elche, Alicante, Spain

Llandough Hospital; Llandough Hospital Memory Team 3rd Floor Academic Building; 🇬🇧 Cardiff, United Kingdom

Fundación ACE; Servicio de Neurología; 🇪🇸 Barcelona, Spain

California Neuroscience Research Medical Group, Inc; 🇺🇸 Sherman Oaks, California, United States

The Queen Elizabeth Hospital; Neurology; 🇦🇺 Woodville, South Australia, Australia

Rigshospitalet, Hukommelsesklinikken; 🇩🇰 København Ø, Denmark

Alpha Recherche Clinique; 🇨🇦 Quebec, Canada

Azienda Ospedaliera Spedali Civili; Scienze Neurologiche; 🇮🇹 Brescia, Lombardia, Italy

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of

Przychodnia Specjalistyczna PROSEN; 🇵🇱 Warszawa, Poland

Brain Research Center B.V; 🇳🇱 Amsterdam, Netherlands

Ewha Womans University Hospital (Seoul); 🇰🇷 Seoul, Korea, Republic of

Felix Platter-Spital Medizin Geriatrie; 🇨🇭 Basel, Switzerland

Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica ? Dipartimento di Neuroscienze; 🇮🇹 Modena, Emilia-Romagna, Italy

Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research; 🇺🇸 Kalamazoo, Michigan, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

IRCCS ?Centro S. Giovanni di Dio? Fatebenefratelli -UO Alzheimer; 🇮🇹 Brescia, Lombardia, Italy

Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia; 🇮🇹 Milano, Lombardia, Italy

Medical Corporation Hakuyokai Kashiwado Hospital; 🇯🇵 Chiba, Japan

National Hospital Organization Hiroshima-Nishi Medical Center; 🇯🇵 Hiroshima, Japan

Hospital Mexico Americano; 🇲🇽 Guadalajara, Mexico CITY (federal District), Mexico

Hospital Universitario; Dr. Jose E. Gonzalez; 🇲🇽 Monterrey, Nuevo LEON, Mexico

AVIX Investigación Clínica S.C; 🇲🇽 Monterrey, Nuevo LEON, Mexico

Seoul St Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

True North Clinical Research-Halifax; 🇨🇦 Halifax, Nova Scotia, Canada

Hospital Mutua De Terrasa; Servicio de Neurologia; 🇪🇸 Terrassa, Barcelona, Spain