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

December 21, 2023 updated by: Hoffmann-La Roche

An Open-Label, Multicenter, Rollover Study to Evaluate the Safety and Tolerability of Long-Term Administration of Gantenerumab in Participants With Alzheimer's Disease

The main purpose of the study was to evaluate the safety and tolerability of long-term administration of gantenerumab in participants with AD. All participants who have completed the open-label extensions (OLEs) of studies WN25203 or WN28745 were enrolled in Part 1 of this study. Of these, participants who completed Week 104 visit in Part 1. Participants received open-label gantenerumab by subcutaneous (SC) injection every four weeks (Q4W) at the same dose as administered in the parent studies (part 1)/ Week 104 visit.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma Buenos Aires, Argentina, C1426ANZ
        • Instituto Neurologia Bs As
  • Australia
    • South Australia
      • Woodville, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital; Neurology
    • Victoria
      • Heidelberg West, Victoria, Australia, 3081
        • Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
  • Canada
      • Quebec, Canada, G3K 2P8
        • ALPHA Recherche Clinique
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3S 1N2
        • True North Clinical Research-Halifax
      • Halifax, Nova Scotia, Canada, B3S 1N2
        • Centricity Research
    • Ontario
      • Peterborough, Ontario, Canada, K9H 2P4
        • Kawartha Centre - Redefining Healthy Aging
      • Toronto, Ontario, Canada, M3B 2S7
        • Toronto Memory Program
  • Chile
      • Santiago, Chile, 7560356
        • Especialidades Medicas LYS
  • Denmark
      • København Ø, Denmark, 2100
        • Rigshospitalet, Hukommelsesklinikken
  • Italy
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41126
        • Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica ? Dipartimento di Neuroscienze
    • Lombardia
      • Brescia, Lombardia, Italy, 25100
        • Azienda Ospedaliera Spedali Civili; Scienze Neurologiche
      • Brescia, Lombardia, Italy, 25125
        • IRCCS ?Centro S. Giovanni di Dio? Fatebenefratelli -UO Alzheimer
      • Castellanza, Lombardia, Italy, 21053
        • Irccs Multimedica Santa Maria; Unita' Di Neurologia
      • Milano, Lombardia, Italy, 20132
        • Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia
  • Japan
      • Chiba, Japan, 260-8656
        • Medical Corporation Hakuyokai Kashiwado Hospital
      • Chiba, Japan, 279-0021
        • Juntendo University Urayasu Hospital; Neurology
      • Hiroshima, Japan, 739-0696
        • National Hospital Organization Hiroshima-Nishi Medical Center
  • Korea, Republic of
      • Incheon, Korea, Republic of, 22332
        • Inha University Hospital
      • Seoul, Korea, Republic of, 06591
        • Seoul St Mary's Hospital
      • Seoul, Korea, Republic of, 07804
        • Ewha Womans University Hospital (Seoul)
  • Mexico
    • Mexico CITY (federal District)
      • Guadalajara, Mexico CITY (federal District), Mexico, 44610
        • Hospital Mexico Americano
    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 64460
        • Hospital Universitario; Dr. Jose E. Gonzalez
      • Monterrey, Nuevo LEON, Mexico, 64710
        • AVIX Investigación Clínica S.C
  • Netherlands
      • Amsterdam, Netherlands, 1081 GN
        • Brain Research Center B.V
  • Poland
      • Pozna?, Poland, 61-853
        • NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek
      • Warszawa, Poland, 01-684
        • Centrum Medyczne NeuroProtect
      • Warszawa, Poland, 01-231
        • Przychodnia Specjalistyczna PROSEN
  • Russian Federation
    • Sankt Petersburg
      • Saint Petersburg, Sankt Petersburg, Russian Federation, 190103
        • Saint Petersburg State Institution of Healthcare City Geriatric Medico-Social Center
      • Sankt-peterburg, Sankt Petersburg, Russian Federation, 194044
        • FSMEI HPE ?Military Medical Academy n.a. S.M.Kirov"of Minist
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar; Servicio de Neurologia
      • Barcelona, Spain, 08028
        • Fundación ACE; Servicio de Neurología
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre; Servicio de Neurologia
      • Valencia, Spain, 46017
        • Hospital Universitario Dr. Peset; Servicio de Neurologia
      • Valencia, Spain, 46026
        • Hospital Universitario la Fe; Servicio de Neurologia
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche; Servicio de Neurología
    • Barcelona
      • Terrassa, Barcelona, Spain, 08222
        • Hospital Mutua De Terrasa; Servicio de Neurologia
  • Switzerland
      • Basel, Switzerland, 4002
        • Felix Platter-Spital Medizin Geriatrie
  • Turkey
      • Istanbul, Turkey, 34093
        • Istanbul University Istanbul School of Medicine; Neurology
      • Izmir, Turkey, 35340
        • Dokuz Eylul University Medicine Faculty; Noroloji Departmani
      • Samsun, Turkey, 55139
        • Ondokuz Mayis University School of Medicine; Neurology
  • United Kingdom
      • Cardiff, United Kingdom, CF64 2XX
        • Llandough Hospital; Llandough Hospital Memory Team 3rd Floor Academic Building
      • London, United Kingdom, W6 8RF
        • Imperial Memory Unit, Charing Cross Hospital; Level 10 West, Department of Neurosciences
      • Newcastle, United Kingdom, NE4 5PL
        • Campus for Ageing & Vitality; Clincal Ageing Research Unit
      • Warrington, United Kingdom, WA2 8WA
        • Hollins Park Hospital
  • United States
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Banner Sun Health Research Insitute
    • California
      • Sherman Oaks, California, United States, 91403
        • California Neuroscience Research Medical Group, Inc
    • Florida
      • Orlando, Florida, United States, 32806
        • Accelerated Enrollment Solutions
      • Tampa, Florida, United States, 33612
        • University of South Florida
      • The Villages, Florida, United States, 32162
        • Bioclinica The Villages
    • Michigan
      • Kalamazoo, Michigan, United States, 49008
        • Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research
    • New York
      • Staten Island, New York, United States, 10314
        • Richmond Behavioral Associates
    • North Carolina
      • Matthews, North Carolina, United States, 28105
        • Alzheimer's Memory Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Central States Research
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Neurology Clinic PC
    • Texas
      • Austin, Texas, United States, 78757
        • Senior Adults Specialty Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SCarlet RoAD
Participants enrolled from the open label extension (OLE) part of parent study WN25203, received gantenerumab, up to 1200 milligram (mg), subcutaneous (SC) injection, every 4 weeks (Q4W) for up to 129 weeks.
Drug: Gantenerumab
Gantenerumab was administered as SC injection Q4W.
Experimental: Marguerite RoAD
Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks.
Drug: Gantenerumab
Gantenerumab was administered as SC injection Q4W.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: 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 existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above, and which does not necessarily have a causal relationship with gantenerumab.
Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Number of Participants With Change in Any Suicidal Ideation or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: 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) & include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0= no suicide risk present. Score of 1 or higher= suicidal ideation/behavior. Number of participants with any suicidal ideation/behavior were reported.
Baseline (Day 1), up to Week 104
Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) AEs
Time Frame: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Number of Participants With Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) AEs
Time Frame: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Number of Participants With Anti-drug Antibody (ADA) to Gantenerumab
Time Frame: Up to Week 133
Up to Week 133
Number of Participants With Injection-Site Reactions
Time Frame: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Number of Participants Who Discontinued Treatment Due to AEs
Time Frame: 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; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above, and which does not necessarily have a causal relationship with gantenerumab.
Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2020

Primary Completion (Actual)

January 4, 2023

Study Completion (Actual)

January 4, 2023

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (Actual)

April 9, 2020

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WN41874

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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