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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04374253




Registration number
NCT04374253
Ethics application status
Date submitted
1/05/2020
Date registered
5/05/2020
Date last updated
20/04/2021

Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)
Scientific 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
Secondary ID [1] 0 0
2020-000766-42
Secondary ID [2] 0 0
WN42171
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
Treatment: Drugs - Gantenerumab

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 104 visit of Study WN29922 or WN39658. This will be considered the OLE baseline visit (OLE Day 1).

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.


Treatment: Drugs: 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 sub-cutaneously (SC) every 2 weeks (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 sub-cutaneously (SC) every 2 weeks (Q2W).

Treatment: Drugs: 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 sub-cutaneously (SC) every 2 weeks (Q2W)

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
From Baseline (OLE Day 1) to Week 104
Primary outcome [2] 0 0
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Timepoint [2] 0 0
From Baseline (OLE Day 1) 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
From Baseline (OLE Day 1) 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
From Baseline (OLE Day 1) to Week 104
Primary outcome [5] 0 0
Percentage of Participants with Injection-Site Reactions (ISRs)
Timepoint [5] 0 0
From Baseline (OLE Day 1) to Week 104
Secondary outcome [1] 0 0
Change in Clinical Dementia Rating (CDR) Score
Timepoint [1] 0 0
From Baseline (OLE Day 1) to Week 104
Secondary outcome [2] 0 0
Change in Mini-Mental State Examination (MMSE) Score
Timepoint [2] 0 0
From Baseline (OLE Day 1) to Week 104
Secondary outcome [3] 0 0
Change in Alzheimer Disease Assessment Scale-Cognition, Subscale 11 (ADAS-Cog11) Score
Timepoint [3] 0 0
From Baseline (OLE Day 1) to Week 104
Secondary outcome [4] 0 0
Change in Alzheimer Disease Assessment Scale-Cognition, Subscale 13 (ADASCog13) Score
Timepoint [4] 0 0
From Baseline (OLE Day 1) to Week 104
Secondary outcome [5] 0 0
Change in Verbal Fluency Task Score
Timepoint [5] 0 0
From Baseline (OLE Day 1) to Week 104
Secondary outcome [6] 0 0
Change in Coding
Timepoint [6] 0 0
From Baseline (OLE Day 1) to Week 104
Secondary outcome [7] 0 0
Change in Functional Activities Questionnaire (FAQ) Score
Timepoint [7] 0 0
From Baseline (OLE Day 1) to Week 104
Secondary outcome [8] 0 0
Change in Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) Score
Timepoint [8] 0 0
From Baseline (OLE Day 1) to Week 104
Secondary outcome [9] 0 0
Plasma Concentration of Gantenerumab Administered SC
Timepoint [9] 0 0
From Baseline (OLE Day 1) to Week 104
Secondary outcome [10] 0 0
Percentage of Participants with Anti-drug Antibody (ADA) to Gantenerumab
Timepoint [10] 0 0
From Baseline (OLE Day 1) to Week 104

Eligibility
Key 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

- 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
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

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
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)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney; Neurology - Darlinghurst
Recruitment hospital [2] 0 0
Central Coast Neurosciences Research - Erina
Recruitment hospital [3] 0 0
Southern Neurology - Kogarah
Recruitment hospital [4] 0 0
The Queen Elizabeth Hospital; Neurology - Woodville
Recruitment hospital [5] 0 0
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre - Heidelberg West
Recruitment hospital [6] 0 0
Australian Alzheimer's Research Foundation - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2250 - Erina
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment postcode(s) [5] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
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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, 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.
Trial website
https://clinicaltrials.gov/show/NCT04374253
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: WN42171 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/NCT04374253