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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04374253
Ethics application status
Date submitted
1/05/2020
Date registered
5/05/2020

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 116 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 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.

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 SC, Q2W
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With at Least One Adverse Event (AE) and Serious Adverse Event (SAE)
Timepoint [1] 0 0
From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Primary outcome [2] 0 0
Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Timepoint [2] 0 0
From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Primary outcome [3] 0 0
Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by MRI
Timepoint [3] 0 0
From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Primary outcome [4] 0 0
Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) Confirmed by MRI
Timepoint [4] 0 0
From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Primary outcome [5] 0 0
Number of Participants With Injection-Site Reactions (ISRs)
Timepoint [5] 0 0
From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Primary outcome [6] 0 0
Number of Participants Who Discontinued the Study Due an AE
Timepoint [6] 0 0
From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Primary outcome [7] 0 0
Number of Participants With at Least One Adverse Event of Special Interest (AESI)
Timepoint [7] 0 0
From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Secondary outcome [1] 0 0
Change From Baseline Over Time in Clinical Dementia Rating - Global Score (CDR-GS)
Timepoint [1] 0 0
Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
Secondary outcome [2] 0 0
Change From Baseline Over Time in Clinical Dementia Rating (CDR) - Sum of Boxes (SB)
Timepoint [2] 0 0
Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
Secondary outcome [3] 0 0
Change From Baseline Over Time in Mini-Mental State Examination (MMSE) Score
Timepoint [3] 0 0
Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
Secondary outcome [4] 0 0
Change From Baseline Over Time in Alzheimer Disease Assessment Scale-Cognition, Subscale 11 (ADAS-Cog11) Score
Timepoint [4] 0 0
Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
Secondary outcome [5] 0 0
Change From Baseline Over Time in Alzheimer Disease Assessment Scale-Cognition, Subscale 13 (ADAS-Cog13) Score
Timepoint [5] 0 0
Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
Secondary outcome [6] 0 0
Change From Baseline Over Time in Verbal Fluency Task Score
Timepoint [6] 0 0
Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
Secondary outcome [7] 0 0
Change From Baseline Over Time in Coding (Digit Symbol Substitution Test [DSST]) Subset
Timepoint [7] 0 0
Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
Secondary outcome [8] 0 0
Change in Functional Activities Questionnaire (FAQ) Score
Timepoint [8] 0 0
Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
Secondary outcome [9] 0 0
Change in Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) Score
Timepoint [9] 0 0
Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
Secondary outcome [10] 0 0
Number of Participants With Anti-drug Antibody (ADA) to Gantenerumab
Timepoint [10] 0 0
From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

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
* 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
Minimum age
No limit
Maximum age
No limit
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/03/2023
Sample size
Target
Accrual to date
Final
1382
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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United States of America
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Changhua County
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Kaohsiung
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Taipei
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Turkey
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Samsun
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Bath
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Birmingham
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Southampton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT04374253