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A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration 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: NCT04374253
Recruitment Status : Active, not recruiting
First Posted : May 5, 2020
Last Update Posted : December 19, 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, 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.

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

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2032 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Rollover Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : February 23, 2023
Estimated Study Completion Date : February 23, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
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).
 Drug: Gantenerumab
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.
Experimental: Group 2
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.
 Drug: Gantenerumab
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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From Baseline (OLE Day 1) to Week 208 ]
  2. Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score [ Time Frame: From Baseline (OLE Day 1) to Week 208 ]
  3. Percentage of Participants with Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI) [ Time Frame: From Baseline (OLE Day 1) to Week 208 ]
  4. Percentage of Participants with Amyloid-Related Imaging Abnormalities-Haemosiderin deposition (ARIA-H) Confirmed by MRI [ Time Frame: From Baseline (OLE Day 1) to Week 208 ]
  5. Percentage of Participants with Injection-Site Reactions (ISRs) [ Time Frame: From Baseline (OLE Day 1) to Week 208 ]

Secondary Outcome Measures :
  1. Change in Clinical Dementia Rating (CDR) Score [ Time Frame: From Baseline (OLE Day 1) to Week 208 ]
  2. Change in Mini-Mental State Examination (MMSE) Score [ Time Frame: From Baseline (OLE Day 1) to Week 208 ]
  3. Change in Alzheimer Disease Assessment Scale-Cognition, Subscale 11 (ADAS-Cog11) Score [ Time Frame: From Baseline (OLE Day 1) to Week 208 ]
  4. Change in Alzheimer Disease Assessment Scale-Cognition, Subscale 13 (ADAS-Cog13) Score [ Time Frame: From Baseline (OLE Day 1) to Week 208 ]
  5. Change in Verbal Fluency Task Score [ Time Frame: From Baseline (OLE Day 1) to Week 208 ]
  6. Change in Coding [ Time Frame: From Baseline (OLE Day 1) to Week 208 ]
  7. Change in Functional Activities Questionnaire (FAQ) Score [ Time Frame: From Baseline (OLE Day 1) to Week 208 ]
  8. Change in Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) Score [ Time Frame: From Baseline (OLE Day 1) to Week 208 ]
  9. Percentage of Participants with Anti-drug Antibody (ADA) to Gantenerumab [ Time Frame: From Baseline (OLE Day 1) to Week 208 ]

Other Outcome Measures:
  1. Plasma Concentration of Gantenerumab Administered SC [ Time Frame: From Baseline (OLE Day 1) to Week 208 ]
    Re-classified as 'Other Pre-specified' due to sparse PK sampling, to support population PK analysis of the data which is an exploratory analysis.


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:

  • Completed Study WN29922 or WN39658, either its double-blind part or OLE part, and did not discontinue study drug early
  • The participant should be capable of completing assessments either alone or with the help of the caregiver
  • Availability of a person (referred to as the "caregiver")
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception methods with a failure rate of <1% per year (bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices) during the treatment period and for at least 16 weeks after the final dose of gantenerumab
  • Agreement not to donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug

Exclusion Criteria:

  • Pregnant or breastfeeding, or intending to become pregnant during the study or within at least 16 weeks after the final dose of study drug
  • Prematurely discontinued from Study WN29922 or WN39658
  • Any medical condition that may jeopardize the participant's safety if he or she continues to receive study treatment
  • Received any investigational treatment other than gantenerumab during or since completion of Study WN29922 or WN39658, either its double-blind or OLE part
  • Evidence of disseminated leptomeningeal hemosiderosis
  • Evidence of intracerebral macrohemorrhage
  • Use of prohibited medication
  • Evidence of ARIA-E on the last MRI scan report in Study WN29922 or WN39658, either its double-blind or OLE part
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): NCT04374253


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: NCT04374253    
Other Study ID Numbers: WN42171
2020-000766-42 ( EudraCT Number )
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: December 19, 2022
Last Verified: December 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.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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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
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs