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Trial record 4 of 17 for:    Gantenerumab
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A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04339413
Recruitment Status : Active, not recruiting
First Posted : April 9, 2020
Last Update Posted : March 18, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This is an open-label, multicenter, rollover study 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 will be eligible to participate in Part 1 of this study. Of these, participants who complete Week 104 visit in Part 1 will be eligible for Part 2 of this study. Participants will continue receiving 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 (part 2).

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Gantenerumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Rollover Study to Evaluate the Safety and Tolerability of Long-Term Administration of Gantenerumab in Participants With Alzheimer's Disease
Actual Study Start Date : May 22, 2020
Estimated Primary Completion Date : May 27, 2025
Estimated Study Completion Date : May 27, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Gantenerumab
Participants will continue receiving open-label gantenerumab by subcutaneous (SC) injection every four weeks (Q4W) up to Week 208.
 Drug: Gantenerumab
Gantenerumab will be administered as SC injection Q4W


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 4 weeks after the last dose of study drug (Baseline [Day 1] up to Week 212) ]
  2. Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score [ Time Frame: Baseline (Day 1) up to Week 208 ]
  3. Percentage of Participants with Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline (Day 1) up to Week 208 ]
  4. Percentage of Participants with Amyloid-Related Imaging Abnormalities-Haemosiderin deposition (ARIA-H) Confirmed by MRI [ Time Frame: Baseline (Day 1) up to Week 208 ]
  5. Percentage of Participants With Anti-drug Antibody (ADA) to Gantenerumab [ Time Frame: Baseline (Day 1) up to Week 208 ]
  6. Percentage of Participants with Injection-Site Reactions [ Time Frame: Up to 4 weeks after the last dose of study drug (Baseline [Day 1] up to Week 212) ]
  7. Percentage of Participants Who Discontinued Treatment due to AEs [ Time Frame: Baseline (Day 1) up to Week 208 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04339413


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04339413    
Other Study ID Numbers: WN41874
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: March 18, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders