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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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2010-019895-66
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Secondary ID [2]
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WN25203
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Universal Trial Number (UTN)
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Trial acronym
Scarlet Road
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mean Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Total Score at Week 104 (Double-Blind Treatment Phase)
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Assessment method [1]
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The CDR (Clinical Dementia Rating) is obtained through semi-structured interviews of participants and informants, and cognitive functioning is rated in six domains of functioning: memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a five-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment. The CDR-SOB (Clinical Dementia Rating-Sum of Boxes) is based on summing each of the domain box scores with total scores ranging from 0-18, where lower total scores represent better outcomes and higher total scores represent worse outcomes.
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Timepoint [1]
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Baseline, Week 104
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Primary outcome [2]
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Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) (OLE Phase)
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Assessment method [2]
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An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
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Timepoint [2]
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Baseline up until a maximum of 5 years
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Secondary outcome [1]
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Mean Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog-11) Scores at Week 104 (Double-Blind Treatment Phase)
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Assessment method [1]
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The ADAS-Cog-11 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The score range for ADAS-Cog-11 is from 0 to 70 with higher scores representing severe dysfunction.
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Timepoint [1]
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Baseline, Week 104
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Secondary outcome [2]
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Time to Onset of Dementia at Week 104 (Double-Blind Treatment Phase)
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Assessment method [2]
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Time to Onset of Dementia was defined as the time interval between the first treatment date and the date that participant is assessed as having Alzheimer-type dementia by investigators.
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Timepoint [2]
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Baseline, Week 104
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Secondary outcome [3]
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Mean Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Composite Score at Week 104 (Double-Blind Treatment Phase)
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Assessment method [3]
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The Cambridge Neuropsychological Test Automated Battery (CANTAB) ® is a cognitive test battery that incorporates a variety of executive and memory tasks in order to assess neuropsychological function. The end outcome as reported below, is a Z-Composite Score. The score range of the Z-Composite Score is from (-) infinity to (+) infinity with a score of zero representing the population mean, lower (negative) scores representing poorer cognitive outcomes and higher (positive) scores representing better cognitive outcomes.
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Timepoint [3]
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Baseline, Week 104
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Secondary outcome [4]
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Mean Change From Baseline in Free and Cued Selective Reminding Test (FCSRT) Score at Week 104 (Double-Blind Treatment Phase)
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Assessment method [4]
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FCSRT assesses verbal episodic memory. Performances in free recalls, cued recalls and in a recognition task were analyzed, as the process of encoding is controlled. Participants were asked to remember a list of 16 words. Three tasks of free and cued recalls, as well as 1 recognition task and one delayed recall give the scores. Total recall was obtained by the addition of cued recalls to free recalls. Maximum score is 48 for immediate: 16 words multiplied by (*) 3 corresponding to immediate free recall + immediate cued recall + immediate recognition test. Maximum score is 64 (better score) when delayed recall: 16 words*4. The minimum score is 0 (worse).
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Timepoint [4]
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Baseline, Week 104
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Secondary outcome [5]
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Mean Change From Baseline in Functional Activities Questionnaire (FAQ) Score at Week 104 (Double-Blind Treatment Phase)
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Assessment method [5]
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Participants completed the FAQ for physical function. Overall scores ranged from 0 (independent) to 30 (dependent) where lower scores represented an improvement in physical function.
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Timepoint [5]
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Baseline, Week 104
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Secondary outcome [6]
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Mean Change From Baseline in CDR-Global Score at Week 104 (Double-Blind Treatment Phase)
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Assessment method [6]
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The CDR-GS represents a semi-structured interview which rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care) on a 5-point scale in which CDR 0 = no dementia and CDR 0.5, 1, 2 or 3 = questionable, mild, moderate or severe dementia respectively. The range in scores for the CDR-GS is from 0 to 3 and a high score on the CDR-GS would indicate a high disease severity.
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Timepoint [6]
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Baseline, Week 104
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Secondary outcome [7]
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Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Questionnaire Score at Week 104 (Double-Blind Treatment Phase)
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Assessment method [7]
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The NPI is a retrospective (to 1 month) caregiver-informant interview assessing frequency and severity of 12 neuropsychiatric symptom domains. The NPI score is based on the sum of the severity ratings (0=absent, 1=mild, 3=severe). The 12 symptom domains include delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, nighttime behavioral disturbances, and appetite/eating abnormalities. The NPI severity score is based on severity ratings (0=absent, 1=mild to 3=severe).
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Timepoint [7]
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Baseline, Week 104
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Secondary outcome [8]
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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)
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Assessment method [8]
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CSF biomarker phospho-tau (p-tau) is an indicator of neuronal injury and neurodegeneration. An elevation in levels of tau, as well as specific p-tau species, is thought to be a marker for progressive cellular degeneration in AD.
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Timepoint [8]
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Baseline, Week 104
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Secondary outcome [9]
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Percentage Change From Baseline in Hippocampal Volume at Week 104 (Double-Blind Treatment Phase)
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Assessment method [9]
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Change from baseline in hippocampal right volume (HRV) and hippocampal left volume (HLV) were analysed at Week 104 using magnetic resonance imaging.
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Timepoint [9]
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Baseline, Week 104
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Secondary outcome [10]
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Percentage Change From Baseline in Cortical Composite Sustained Uptake Volume Ratio (SUVr) in Different Brain Regions at Week 156 (Double-Blind Treatment Phase)
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Assessment method [10]
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The different regions of the brain that were analyzed included cerebellum gray, whole cerebellum, composite white matter, subcortical white matter, pons and composite reference.
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Timepoint [10]
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Baseline, Week 156
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Secondary outcome [11]
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Gantenerumab Plasma Concentrations at Different Time Points (Double-Blind Treatment Phase)
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Assessment method [11]
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The PK analyses includes tabulation of plasma concentration data and summarisation of plasma concentrations by visits with participants grouped according to treatment received. Descriptive summary statistics for the Arithmetic Mean and Standard Deviation are presented below.
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Timepoint [11]
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Pre-Dose: Weeks 8, 20, 44, 68 and 100; Post-Dose: Weeks 1, 53 and 101
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Secondary outcome [12]
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Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 104 (Double-Blind Treatment Phase)
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Assessment method [12]
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The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement.
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Timepoint [12]
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Baseline, Week 104
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Secondary outcome [13]
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Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) (Double-Blind Treatment Phase)
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Assessment method [13]
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An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
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Timepoint [13]
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Baseline up until a maximum of 4.5 years
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Secondary outcome [14]
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Percentage of Participants With Anti-Drug Antibodies (ADAs) (Double-Blind Treatment Phase)
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Assessment method [14]
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Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined for Gantenerumab and Placebo groups. The prevalence of ADA at baseline was calculated as the proportion of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the proportion of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis.
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Timepoint [14]
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0
Baseline up until a maximum of 4.5 years
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Secondary outcome [15]
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Mean Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog-11) Scores at Week 156 (OLE Phase)
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Assessment method [15]
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The ADAS-Cog-11 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The score range for ADAS-Cog-11 is from 0 to 70 with higher scores representing severe dysfunction.
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Timepoint [15]
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Baseline, Week 156
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Secondary outcome [16]
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Mean Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Total Score at Week 156 (OLE Phase)
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Assessment method [16]
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The CDR (Clinical Dementia Rating) is obtained through semi-structured interviews of participants and informants, and cognitive functioning is rated in six domains of functioning: memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a five-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment. The CDR-SOB (Clinical Dementia Rating-Sum of Boxes) is based on summing each of the domain box scores with total scores ranging from 0-18, where lower total scores represent better outcomes and higher total scores represent worse outcomes.
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Timepoint [16]
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0
Baseline, Week 156
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Secondary outcome [17]
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Mean Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog-13) Scores at Week 156 (OLE Phase)
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Assessment method [17]
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The ADAS-Cog-13 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. The score range for ADAS-Cog-13 is from 0 to 85 with higher scores representing severe dysfunction.
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Timepoint [17]
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Baseline, Week 156
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Secondary outcome [18]
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Time to Onset of Dementia at Week 156 (OLE Phase)
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Assessment method [18]
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Time to Onset of Dementia was defined as the time interval between the first treatment date and the date that participant is assessed as having Alzheimer-type dementia by investigators.
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Timepoint [18]
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Baseline, Week 156
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Secondary outcome [19]
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Mean Change From Baseline in Free and Cued Selective Reminding Test (FCSRT) Score at Week 156 (OLE Phase)
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Assessment method [19]
0
0
FCSRT assesses verbal episodic memory. Performances in free recalls, cued recalls and in a recognition task were analyzed, as the process of encoding is controlled. Participants were asked to remember a list of 16 words. Three tasks of free and cued recalls, as well as 1 recognition task and one delayed recall give the scores. Total recall was obtained by the addition of cued recalls to free recalls. Maximum score is 48 for immediate: 16 words multiplied by (*) 3 corresponding to immediate free recall + immediate cued recall + immediate recognition test. Maximum score is 64 (better score) when delayed recall: 16 words*4. The minimum score is 0 (worse).
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Timepoint [19]
0
0
Baseline, Week 156
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Secondary outcome [20]
0
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Mean Change From Baseline in Functional Activities Questionnaire (FAQ) Score at Week 156 (OLE Phase)
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Assessment method [20]
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Participants completed the FAQ for physical function. Overall scores ranged from 0 (independent) to 30 (dependent) where lower scores represented an improvement in physical function.
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Timepoint [20]
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Baseline, Week 156
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Secondary outcome [21]
0
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Mean Change From Baseline in CDR-Global Score at Week 156 (OLE Phase)
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Assessment method [21]
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The CDR-GS represents a semi-structured interview which rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care) on a 5-point scale in which CDR 0 = no dementia and CDR 0.5, 1, 2 or 3 = questionable, mild, moderate or severe dementia respectively. The range in scores for the CDR-GS is from 0 to 3 and a high score on the CDR-GS would indicate a high disease severity.
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Timepoint [21]
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Baseline, Week 156
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Secondary outcome [22]
0
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Percentage Change From Baseline in Hippocampal Volume at Week 152 (OLE Phase)
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Assessment method [22]
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Change from baseline in hippocampal right volume (HRV) and hippocampal left volume (HLV) were analysed at Week 152 using magnetic resonance imaging.
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Timepoint [22]
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Baseline, Week 152
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Secondary outcome [23]
0
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Percentage Change From Baseline in Cortical Composite Sustained Uptake Volume Ratio (SUVr) in Different Brain Regions at Week 156 (OLE Phase)
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Assessment method [23]
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The regions of the brain that were analyzed included cerebellum gray and composite reference.
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Timepoint [23]
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Baseline, Week 156
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Secondary outcome [24]
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Gantenerumab Plasma Concentrations at Different Time Points (OLE Phase)
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Assessment method [24]
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The PK analyses includes tabulation of plasma concentration data and summarisation of plasma concentrations by visits with participants grouped according to treatment received. Descriptive summary statistics for the Arithmetic Mean and Standard Deviation are presented below.
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Timepoint [24]
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Pre-Dose: Weeks 64, 100, 104, 136, 156 and 208; Post-Dose: Week 101
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Secondary outcome [25]
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Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 156 (OLE Phase)
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Assessment method [25]
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0
The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement.
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Timepoint [25]
0
0
Baseline, Week 156
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Secondary outcome [26]
0
0
Percentage of Participants With Anti-Drug Antibodies (ADAs) (OLE Phase)
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Assessment method [26]
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Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined. The prevalence of ADA at baseline was calculated as the proportion of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the proportion of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis.
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Timepoint [26]
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Baseline up until a maximum of 5 years
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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
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Minimum age
50
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/11/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
10/09/2020
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Sample size
Target
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Accrual to date
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Final
799
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Hornsby Ku-ring-gai Hospital; Division of Rehabilitation & Aged Care - Hornsby
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Recruitment hospital [2]
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Prince of Wales Hospital, Academic Department for Old Age Psychiatry - Randwick
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Recruitment hospital [3]
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Royal Adelaide Hospital; Memory Trials Centre - Adelaide
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Recruitment hospital [4]
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The Queen Elizabeth Hospital; Neurology - Woodville
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Recruitment hospital [5]
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Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre - Heidelberg West
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Recruitment hospital [6]
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Australian Alzheimer's Research Foundation - Nedlands
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Recruitment postcode(s) [1]
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0
2077 - Hornsby
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Recruitment postcode(s) [2]
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0
2031 - Randwick
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Recruitment postcode(s) [3]
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0
5000 - Adelaide
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Recruitment postcode(s) [4]
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0
5011 - Woodville
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Recruitment postcode(s) [5]
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0
3081 - Heidelberg West
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Recruitment postcode(s) [6]
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0
6009 - Nedlands
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Connecticut
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Florida
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Indiana
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Massachusetts
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Michigan
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Mississippi
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Country [9]
0
0
United States of America
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State/province [9]
0
0
New Jersey
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Country [10]
0
0
United States of America
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State/province [10]
0
0
New York
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Country [11]
0
0
United States of America
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State/province [11]
0
0
North Carolina
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Oregon
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Pennsylvania
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Rhode Island
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Texas
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Country [16]
0
0
United States of America
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State/province [16]
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0
Vermont
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Country [17]
0
0
Argentina
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State/province [17]
0
0
Buenos Aires
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Country [18]
0
0
Argentina
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State/province [18]
0
0
Caba
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Country [19]
0
0
Argentina
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State/province [19]
0
0
Córdoba
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Country [20]
0
0
Argentina
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State/province [20]
0
0
La Plata
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Country [21]
0
0
Belgium
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State/province [21]
0
0
Leuven
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Country [22]
0
0
Brazil
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State/province [22]
0
0
PR
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Country [23]
0
0
Brazil
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State/province [23]
0
0
RS
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Country [24]
0
0
Brazil
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State/province [24]
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Bron
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Italy
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Seoul
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Mexico
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'S Hertogenbosch
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Netherlands
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Amsterdam
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Bialystok
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Russian Federation
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Russian Federation
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Kazan
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saratov
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Russian Federation
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St. Petersburg
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Antalya
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Istanbul
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Samsun
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Epping
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Glasgow
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Swindon
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United Kingdom
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Warrington
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Summary
Brief summary
This multi-center, randomized, double-blind, placebo-controlled parallel-group study will
evaluate the effect of gantenerumab (RO4909832) on cognition and functioning and the safety
and pharmacokinetics in participants with prodromal Alzheimer's Disease. Participants will be
randomized to receive subcutaneous (SC) injections of either gantenerumab or placebo.
Participants who consent to be part of the sub study will undergo positron emission
tomography (PET) scanning to assess brain amyloid. The anticipated time on study treatment is
104 weeks in Part 1, with an option for an additional up to 2 years of treatment in Part 2,
followed by an open-label extension (Part 3) until July 2020.
The dosing for Parts 1 and 2 was stopped after a planned futility interim analysis showed a
low probability of meeting the primary outcome measure with the doses studied. The study has
converted to open-label to investigate higher gantenerumab doses.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01224106
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Contacts
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Clinical Trials
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Hoffmann-La Roche
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01224106
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