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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
116

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 22, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 4, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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