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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01224106




Registration number
NCT01224106
Ethics application status
Date submitted
14/10/2010
Date registered
19/10/2010
Date last updated
13/12/2021

Titles & IDs
Public title
A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease
Scientific title
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Two Year Study to Evaluate the Effect of Subcutaneous RO4909832 on Cognition and Function in Prodromal Alzheimer's Disease With Option for up to an Additional Two Years of Treatment and an Open-Label Extension With Active Study Treatment
Secondary ID [1] 0 0
2010-019895-66
Secondary ID [2] 0 0
WN25203
Universal Trial Number (UTN)
Trial acronym
Scarlet Road
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's 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 - Placebo

Placebo comparator: Placebo (Parts 1 and 2) - Participants with Alzheimer's disease received Placebo by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.

Experimental: Gantenerumab 105 mg (Parts 1 and 2) - Participants with Alzheimer's disease received Gantenerumab 105 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.

Experimental: Gantenerumab 225 mg (Parts 1 and 2) - Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.

Placebo comparator: Placebo (Parts 1 and 2) switched to Gantenerumab Up to 1200mg (Part 3 Open-Label Extension [OLE]) - Participants with Alzheimer's disease who had received Placebo by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years.

Experimental: Gantenerumab Up to 1200 mg (Part 3 Open-Label Extension [OLE]) - Participants with Alzheimer's disease who had received Gantenerumab by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years.


Treatment: Drugs: Gantenerumab
Participants received Gantenerumab at 105 mg , 225 mg, or at doses up to 1200 mg SC injection Q4W.

Treatment: Drugs: Placebo
Participants received Placebo SC injection Q4W.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Total Score at Week 104 (Double-Blind Treatment Phase)
Timepoint [1] 0 0
Baseline, Week 104
Primary outcome [2] 0 0
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) (OLE Phase)
Timepoint [2] 0 0
Baseline up until a maximum of 5 years
Secondary outcome [1] 0 0
Mean Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog-11) Scores at Week 104 (Double-Blind Treatment Phase)
Timepoint [1] 0 0
Baseline, Week 104
Secondary outcome [2] 0 0
Time to Onset of Dementia at Week 104 (Double-Blind Treatment Phase)
Timepoint [2] 0 0
Baseline, Week 104
Secondary outcome [3] 0 0
Mean Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Composite Score at Week 104 (Double-Blind Treatment Phase)
Timepoint [3] 0 0
Baseline, Week 104
Secondary outcome [4] 0 0
Mean Change From Baseline in Free and Cued Selective Reminding Test (FCSRT) Score at Week 104 (Double-Blind Treatment Phase)
Timepoint [4] 0 0
Baseline, Week 104
Secondary outcome [5] 0 0
Mean Change From Baseline in Functional Activities Questionnaire (FAQ) Score at Week 104 (Double-Blind Treatment Phase)
Timepoint [5] 0 0
Baseline, Week 104
Secondary outcome [6] 0 0
Mean Change From Baseline in CDR-Global Score at Week 104 (Double-Blind Treatment Phase)
Timepoint [6] 0 0
Baseline, Week 104
Secondary outcome [7] 0 0
Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Questionnaire Score at Week 104 (Double-Blind Treatment Phase)
Timepoint [7] 0 0
Baseline, Week 104
Secondary outcome [8] 0 0
Percentage Change From Baseline in Cerebrospinal Fluid Biomarkers (Phosphorylated-tau [P-tau], Amyloid Beta 1-42 [Abeta 1-42], Total Tau [T-tau]) at Week 104 (Double-Blind Treatment Phase)
Timepoint [8] 0 0
Baseline, Week 104
Secondary outcome [9] 0 0
Percentage Change From Baseline in Hippocampal Volume at Week 104 (Double-Blind Treatment Phase)
Timepoint [9] 0 0
Baseline, Week 104
Secondary outcome [10] 0 0
Percentage Change From Baseline in Cortical Composite Sustained Uptake Volume Ratio (SUVr) in Different Brain Regions at Week 156 (Double-Blind Treatment Phase)
Timepoint [10] 0 0
Baseline, Week 156
Secondary outcome [11] 0 0
Gantenerumab Plasma Concentrations at Different Time Points (Double-Blind Treatment Phase)
Timepoint [11] 0 0
Pre-Dose: Weeks 8, 20, 44, 68 and 100; Post-Dose: Weeks 1, 53 and 101
Secondary outcome [12] 0 0
Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 104 (Double-Blind Treatment Phase)
Timepoint [12] 0 0
Baseline, Week 104
Secondary outcome [13] 0 0
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) (Double-Blind Treatment Phase)
Timepoint [13] 0 0
Baseline up until a maximum of 4.5 years
Secondary outcome [14] 0 0
Percentage of Participants With Anti-Drug Antibodies (ADAs) (Double-Blind Treatment Phase)
Timepoint [14] 0 0
Baseline up until a maximum of 4.5 years
Secondary outcome [15] 0 0
Mean Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog-11) Scores at Week 156 (OLE Phase)
Timepoint [15] 0 0
Baseline, Week 156
Secondary outcome [16] 0 0
Mean Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Total Score at Week 156 (OLE Phase)
Timepoint [16] 0 0
Baseline, Week 156
Secondary outcome [17] 0 0
Mean Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog-13) Scores at Week 156 (OLE Phase)
Timepoint [17] 0 0
Baseline, Week 156
Secondary outcome [18] 0 0
Time to Onset of Dementia at Week 156 (OLE Phase)
Timepoint [18] 0 0
Baseline, Week 156
Secondary outcome [19] 0 0
Mean Change From Baseline in Free and Cued Selective Reminding Test (FCSRT) Score at Week 156 (OLE Phase)
Timepoint [19] 0 0
Baseline, Week 156
Secondary outcome [20] 0 0
Mean Change From Baseline in Functional Activities Questionnaire (FAQ) Score at Week 156 (OLE Phase)
Timepoint [20] 0 0
Baseline, Week 156
Secondary outcome [21] 0 0
Mean Change From Baseline in CDR-Global Score at Week 156 (OLE Phase)
Timepoint [21] 0 0
Baseline, Week 156
Secondary outcome [22] 0 0
Percentage Change From Baseline in Hippocampal Volume at Week 152 (OLE Phase)
Timepoint [22] 0 0
Baseline, Week 152
Secondary outcome [23] 0 0
Percentage Change From Baseline in Cortical Composite Sustained Uptake Volume Ratio (SUVr) in Different Brain Regions at Week 156 (OLE Phase)
Timepoint [23] 0 0
Baseline, Week 156
Secondary outcome [24] 0 0
Gantenerumab Plasma Concentrations at Different Time Points (OLE Phase)
Timepoint [24] 0 0
Pre-Dose: Weeks 64, 100, 104, 136, 156 and 208; Post-Dose: Week 101
Secondary outcome [25] 0 0
Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 156 (OLE Phase)
Timepoint [25] 0 0
Baseline, Week 156
Secondary outcome [26] 0 0
Percentage of Participants With Anti-Drug Antibodies (ADAs) (OLE Phase)
Timepoint [26] 0 0
Baseline up until a maximum of 5 years

Eligibility
Key inclusion criteria
* Adult participants, 50-85 years of age
* Participants with prodromal Alzheimer's disease who are not receiving memantine or cholinesterase inhibitors
* Has a study partner who in the investigator's judgement has frequent and sufficient contact with the participant as to be able to provide accurate information as to the participant's cognitive and functional abilities, who agrees to provide information at clinic visits which require partner input for scale completion
* Has had sufficient education or work experience to exclude mental retardation
* Study partner has noticed a recent gradual decrease in participant's memory (over the last 12 months), which the participant may or may not be aware of
* Screening Mini Mental State Exam (MMSE) score of 24 or above

Additional inclusion criteria for sub study:

* Able and willing to travel to PET imaging center and complete the planned scanning sessions
* Past and planned exposure to ionizing radiation not exceeding safe and permissible levels
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Other prior or current neurologic or medical disorder which may currently or during the course of the study impair cognition or psychiatric functioning
* A history of stroke
* A documented history of transient ischemic attack within the last 12 months
* History of schizophrenia, schizoaffective or bipolar disorder
* Currently meets criteria for major depression
* Within the last 2 years, unstable or clinical significant cardiovascular disease (myocardial infarction, angina pectoris)

Additional exclusion criteria for sub study:

* Inclusion in a research and/or medical protocol involving PET ligands or other radioactive agents within 12 months
* Present or planned participation in a research and/or medical protocol involving PET ligands or radioactive agents other than study WN25203
* Have planned or are planning to have exposure to ionizing radiation that in combination with the planned administration with study amyloid PET ligand would result in a cumulative exposure that exceeds local recommended exposure limits

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/09/2020
Sample size
Target
Accrual to date
Final
799
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Hornsby Ku-ring-gai Hospital; Division of Rehabilitation & Aged Care - Hornsby
Recruitment hospital [2] 0 0
Prince of Wales Hospital, Academic Department for Old Age Psychiatry - Randwick
Recruitment hospital [3] 0 0
Royal Adelaide Hospital; Memory Trials Centre - Adelaide
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
2077 - Hornsby
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
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
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
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
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Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Mississippi
Country [9] 0 0
United States of America
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New Jersey
Country [10] 0 0
United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Rhode Island
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United States of America
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Texas
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United States of America
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Vermont
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Córdoba
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Argentina
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La Plata
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Belgium
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Leuven
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Brazil
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PR
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Brazil
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RS
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Brazil
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SP
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Santiago
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Czechia
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Brno
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Czechia
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Rychnov nad Kneznou
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Denmark
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Aarhus N
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Denmark
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Koebenhavn Oe
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Finland
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Turku
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Bobigny
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Bron
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Caen
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Monterrey
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'S Hertogenbosch
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Bialystok
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Bydgoszcz
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Poznan
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Warszawa
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Portugal
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Amadora
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Portugal
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Vizcaya
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Madrid
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Valencia
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Sweden
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Malmö
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Basel
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Chêne-Bourg
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Antalya
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Istanbul
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Turkey
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Samsun
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United Kingdom
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Cambridge
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United Kingdom
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Cardiff
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United Kingdom
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Epping
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United Kingdom
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Glasgow
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London
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Newcastle
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Southampton
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Swindon
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United Kingdom
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Warrington

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

No information has been provided regarding IPD availability


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/NCT01224106