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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04339413




Registration number
NCT04339413
Ethics application status
Date submitted
7/04/2020
Date registered
9/04/2020
Date last updated
18/01/2024

Titles & IDs
Public title
A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)
Scientific 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
Secondary ID [1] 0 0
WN41874
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Gantenerumab

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.

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.


Treatment: Drugs: Gantenerumab
Gantenerumab was administered as SC injection Q4W.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Primary outcome [2] 0 0
Number of Participants With Change in Any Suicidal Ideation or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Baseline (Day 1), up to Week 104
Primary outcome [3] 0 0
Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) AEs
Assessment method [3] 0 0
Timepoint [3] 0 0
Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Primary outcome [4] 0 0
Number of Participants With Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) AEs
Assessment method [4] 0 0
Timepoint [4] 0 0
Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Primary outcome [5] 0 0
Number of Participants With Anti-drug Antibody (ADA) to Gantenerumab
Assessment method [5] 0 0
Timepoint [5] 0 0
Up to Week 133
Primary outcome [6] 0 0
Number of Participants With Injection-Site Reactions
Assessment method [6] 0 0
Timepoint [6] 0 0
Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Primary outcome [7] 0 0
Number of Participants Who Discontinued Treatment Due to AEs
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/01/2023
Sample size
Target
Accrual to date
Final
116
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital; Neurology - Woodville
Recruitment hospital [2] 0 0
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre - Heidelberg West
Recruitment postcode(s) [1] 0 0
5011 - Woodville
Recruitment postcode(s) [2] 0 0
3081 - Heidelberg West
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Oklahoma
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Argentina
State/province [10] 0 0
Ciudad Autonoma Buenos Aires
Country [11] 0 0
Canada
State/province [11] 0 0
Nova Scotia
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
Chile
State/province [14] 0 0
Santiago
Country [15] 0 0
Denmark
State/province [15] 0 0
København Ø
Country [16] 0 0
Italy
State/province [16] 0 0
Emilia-Romagna
Country [17] 0 0
Italy
State/province [17] 0 0
Lombardia
Country [18] 0 0
Japan
State/province [18] 0 0
Chiba
Country [19] 0 0
Japan
State/province [19] 0 0
Hiroshima
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Incheon
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Seoul
Country [22] 0 0
Mexico
State/province [22] 0 0
Mexico CITY (federal District)
Country [23] 0 0
Mexico
State/province [23] 0 0
Nuevo LEON
Country [24] 0 0
Netherlands
State/province [24] 0 0
Amsterdam
Country [25] 0 0
Poland
State/province [25] 0 0
Pozna?
Country [26] 0 0
Poland
State/province [26] 0 0
Warszawa
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Sankt Petersburg
Country [28] 0 0
Spain
State/province [28] 0 0
Alicante
Country [29] 0 0
Spain
State/province [29] 0 0
Barcelona
Country [30] 0 0
Spain
State/province [30] 0 0
Madrid
Country [31] 0 0
Spain
State/province [31] 0 0
Valencia
Country [32] 0 0
Switzerland
State/province [32] 0 0
Basel
Country [33] 0 0
Turkey
State/province [33] 0 0
Istanbul
Country [34] 0 0
Turkey
State/province [34] 0 0
Izmir
Country [35] 0 0
Turkey
State/province [35] 0 0
Samsun
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Cardiff
Country [37] 0 0
United Kingdom
State/province [37] 0 0
London
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Newcastle
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Warrington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT04339413