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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04339413
Ethics application status
Date submitted
7/04/2020
Date registered
9/04/2020
Date last updated
18/11/2020

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: Gantenerumab - 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.


Treatment: Drugs: Gantenerumab
Gantenerumab will be administered as SC injection Q4W

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Baseline (Day 1) up to Week 104
Primary outcome [2] 0 0
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Timepoint [2] 0 0
Baseline (Day 1) up to Week 104
Primary outcome [3] 0 0
Percentage of Participants with Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI)
Timepoint [3] 0 0
Baseline (Day 1) up to Week 104
Primary outcome [4] 0 0
Percentage of Participants with Amyloid-Related Imaging Abnormalities-Haemosiderin deposition (ARIA-H) Confirmed by MRI
Timepoint [4] 0 0
Baseline (Day 1) up to Week 104
Primary outcome [5] 0 0
Percentage of Participants With Anti-drug Antibody (ADA) to Gantenerumab
Timepoint [5] 0 0
Baseline (Day 1) up to Week 104
Primary outcome [6] 0 0
Percentage of Participants with Injection-Site Reactions
Timepoint [6] 0 0
Baseline (Day 1) up to Week 104
Primary outcome [7] 0 0
Percentage of Participants Who Discontinued Treatment due to AEs
Timepoint [7] 0 0
Baseline (Day 1) up to Week 104

Eligibility
Key inclusion criteria
- Participants who completed the open-label extensions (OLEs) of studies WN25203 or
WN28745

- 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
Minimum age
No limit
Maximum age
No limit
Gender
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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Oklahoma
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Argentina
State/province [9] 0 0
Ciudad Autonoma de Bs As
Country [10] 0 0
Belgium
State/province [10] 0 0
Leuven
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
Japan
State/province [20] 0 0
Okayama
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Busan
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Incheon
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Seongnam-si
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Seoul
Country [25] 0 0
Mexico
State/province [25] 0 0
Culiacan
Country [26] 0 0
Mexico
State/province [26] 0 0
Guadalajara
Country [27] 0 0
Mexico
State/province [27] 0 0
Monterrey
Country [28] 0 0
Netherlands
State/province [28] 0 0
Amsterdam
Country [29] 0 0
Poland
State/province [29] 0 0
Poznan
Country [30] 0 0
Poland
State/province [30] 0 0
Warszawa
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Kazan
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Kirov
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Moscow
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Saint Petersburg
Country [35] 0 0
Spain
State/province [35] 0 0
Alicante
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelona
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
Spain
State/province [38] 0 0
Valencia
Country [39] 0 0
Switzerland
State/province [39] 0 0
Basel
Country [40] 0 0
Turkey
State/province [40] 0 0
Istanbul
Country [41] 0 0
Turkey
State/province [41] 0 0
Izmir
Country [42] 0 0
Turkey
State/province [42] 0 0
Samsun
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Cardiff
Country [44] 0 0
United Kingdom
State/province [44] 0 0
London
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Newcastle
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Warrington

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

Ethics approval
Ethics application status

Summary
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 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.
Trial website
https://clinicaltrials.gov/show/NCT04339413
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: WN41874 www.roche.com/about_roche/roche_worldwide.htm
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
Fax 0 0
Email 0 0
Global-Roche-Genentech-Trials@gene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04339413