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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/NCT02051608
Registration number
NCT02051608
Ethics application status
Date submitted
30/01/2014
Date registered
31/01/2014
Date last updated
10/02/2023
Titles & IDs
Public title
A Study of Gantenerumab in Participants With Mild Alzheimer Disease
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Scientific title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Gantenerumab in Patients With Mild Alzheimer's Disease; Part II: Open-Label Extension For Participating Patients
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Secondary ID [1]
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2013-003390-95
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Secondary ID [2]
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WN28745
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Universal Trial Number (UTN)
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Trial acronym
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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 - Placebo
Treatment: Drugs - Gantenerumab
Placebo Comparator: Part 1 (Double Blind treatment): Placebo - Participants received matching placebo by subcutaneous (SC) injection every 4 weeks (Q4W) up to 100 weeks during Part 1 of the study.
Experimental: Part 1 (Double Blind treatment): Gantenerumab - Participants received 105 mg Gantenerumab by SC injection Q4W for 24 weeks and if eligible 225 mg SC injection Q4W from weeks 28-100 during Part 1 of the study.
Placebo Comparator: Part 2 (Open-Label Extension [OLE] treatment): Placebo switched to Gantenerumab Up to 1200 mg - Participants who had received Placebo in Part 1, received Gantenerumab at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years.
Experimental: Part 2 (OLE treatment): Gantenerumab up to 1200 mg - Participants who had received Gantenerumab in Part 1, received treatment at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years.
Treatment: Drugs: Placebo
Participants received Placebo SC injection Q4W.
Treatment: Drugs: Gantenerumab
Participants received Gantenerumab at 105 mg , 225 mg, or at doses up to 1200 mg 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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Part 2: Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
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Assessment method [1]
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An AE 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. SAE is any adverse event that is fatal or which requires or prolongs inpatient hospitalization or results in persistent or significant disability/incapacity or causes congenital anomaly/birth defect or results in a significant medical event in the investigator's judgment.
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Timepoint [1]
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First dose up to 4 weeks after the last dose of study drug (up to 249 weeks)
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Primary outcome [2]
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Part 2: Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs)
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Assessment method [2]
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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 participants previously (in part 1) on Gantenerumab and Placebo. The prevalence of ADA at baseline was calculated as the percentage 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 percentage 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 [2]
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First dose up to last dose (Baseline up to until maximum 5 years)
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Primary outcome [3]
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Part 2: Percentage of Participants With Adverse Events Leading to Discontinuation of Treatment
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Assessment method [3]
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Percentage of participants with adverse events leading to discontinuation from treatment were reported.
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Timepoint [3]
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First dose up to 4 weeks after the last dose in OLE (Up to approximately 249 weeks)
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Secondary outcome [1]
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Part 1: Percentage of Participants With AEs, SAEs
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Assessment method [1]
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An AE 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. A serious adverse event is any adverse event that is fatal or which requires or prolongs inpatient hospitalization or results in persistent or significant disability/incapacity or causes congenital anomaly/birth defect or results in a significant medical event in the investigator's judgment.
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Timepoint [1]
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First dose up to last dose (Up to approximately 152 weeks)
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Secondary outcome [2]
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Part 1: Percentage of Participants With Treatment Emergent ADAs
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Assessment method [2]
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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 participants previously (in part 1) on Gantenerumab and Placebo. The prevalence of ADA at baseline was calculated as the percentage 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 percentage 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 [2]
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First dose up to last dose (Up to approximately 152 weeks)
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Secondary outcome [3]
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Part 1: Gantenerumab Plasma Concentration at Multiple Timepoints
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Assessment method [3]
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Timepoint [3]
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Pre-dose: Weeks 4, 8, 12, 24, 48, 72 and Post dose: Day 4
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Secondary outcome [4]
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Part 1: Percentage of Participants With Adverse Events Leading to Discontinuation of Treatment
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Assessment method [4]
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Percentage of participants with adverse events leading to discontinuation from treatment were reported.
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Timepoint [4]
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First dose up to last dose (Up to approximately 152 weeks)
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Secondary outcome [5]
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Part 2: Percent Change From Baseline in Hippocampal Volume at Week 104
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Assessment method [5]
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Change from baseline in hippocampal right volume (HRV) and hippocampal left volume (HLV) were analyzed at Week 104 using magnetic resonance imaging.
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Timepoint [5]
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Baseline (Part 1 screening), Week 104
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Secondary outcome [6]
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Part 2: Percent Change From Baseline in Whole Brain Volume at Week 104
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Assessment method [6]
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Change from baseline brain volume were analyzed at Week 104 using magnetic resonance imaging.
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Timepoint [6]
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Baseline (Part 1 screening), Week 104
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Secondary outcome [7]
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Part 2: Percent Change From Baseline in Cortical Thickness at Week 104
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Assessment method [7]
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Change from baseline in cortical thickness were analyzed at Week 104 using magnetic resonance imaging.
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Timepoint [7]
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Baseline (Part 1 screening), Week 104
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Secondary outcome [8]
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Part 2: Ventricular Volume as Measured by MRI at Week 104
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Assessment method [8]
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Ventricular volume were analyzed at Week 104 using magnetic resonance imaging.
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Timepoint [8]
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Part 2: Week 104
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Secondary outcome [9]
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Part 2: Gantenerumab Plasma Concentration at Multiple Timepoints
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Assessment method [9]
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Timepoint [9]
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Pre-dose: Weeks 104, 116, 156, 208; Post-dose: Weeks 53, 101
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Secondary outcome [10]
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Part 2: Change From Baseline in Brain Amyloid Load at Week 156 in a Subset of Participants
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Assessment method [10]
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Brain amyloid load over time was assessed using a Florbetapir [F18] injection, a positron emission tomography (PET) radioligand selective to amyloid. Analysis was conducted in a subset of participants who signed consent to participate in the PET substudy. Amyloid PET burden was measured in a composite region of interest (ROI) by using standardized uptake value ratio (SUVR) mapped to the centiloid scale. The composite region was composed of the following six bilateral regions: frontal lobe, parietal lobe, temporal lobe, posterior cingulate cortex, anterior cingulate cortex. The reference region used to normalize the composite region was the cerebellar cortex. SUVR is ratio of tracer uptake in each of cingulate, frontal, parietal and temporal cortexes relative to cerebellum. The centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scans.
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Timepoint [10]
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Baseline, Week 156
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Eligibility
Key inclusion criteria
- Clinical diagnosis of probable mild Alzheimer disease (AD) based on National Institute
of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related
Disorders Association (NINCDS/ADRDA) criteria or major NCD based whether or not
receiving AD approved medication
- Cerebral spinal fluid (CSF) result consistent with the presence of amyloid pathology
- Availability of a person ('caregiver') who in the investigator's judgment has frequent
and sufficient contact with the participant, and is able to provide accurate
information regarding the participant's cognitive and functional abilities
- Fluency in the language of the tests used at the study site
- Willingness and ability to complete all aspects of the study
- Adequate visual and auditory acuity, in the investigator's judgment, sufficient to
perform the neuropsychological testing (eye glasses and hearing aids are permitted)
- If currently receiving approved medications for AD, the dosing regimen must have been
stable for 3 months prior to screening
- Agreement not to participate in other research studies for the duration of this trial
and its associated substudies
PART 2 - All participants who have been randomized and are actively participating in the
study are eligible for Part 2
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Minimum age
50
Years
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Maximum age
90
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
- Dementia or neurocognitive disorder (NCD) due to a condition other than AD, including,
but not limited to, frontotemporal dementia, Parkinson disease, dementia with Lewy
bodies, Huntington disease, or vascular dementia
- History or presence of clinically evident vascular disease potentially affecting the
brain that in the opinion of the investigator has the potential to affect cognitive
function
- History or presence of stroke within the past 2 years or documented history of
transient ischemic attack within the last 12 months
- History or presence of systemic autoimmune disorders potentially causing progressive
neurologic disease with associated cognitive deficits
- History of schizophrenia, schizoaffective disorder, or bipolar disorder
- Alcohol and/or substance use disorder (according to the DSM-5) within the past 2 years
(nicotine use is allowed)
- History or presence of atrial fibrillation
- Within the last 2 years, unstable or clinically significant cardiovascular disease
(e.g., myocardial infarction, angina pectoris, cardiac failure New York Heart
Association Class II or higher)
- Uncontrolled hypertension
- Chronic kidney disease
- Impaired hepatic function
PET imaging substudy, in addition to above:
- Prior participation in other research study or clinical care within the last year such
that the total radiation exposure would exceed the local or national annual limits
Part 2 Participants who have been discontinued from the study
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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
27/03/2014
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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
16/04/2021
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Sample size
Target
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Accrual to date
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Final
389
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Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
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Recruitment hospital [1]
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Royal Adelaide Hospital; Memory Trials Centre - Adelaide
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Recruitment hospital [2]
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The Queen Elizabeth Hospital; Neurology - Woodville
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Recruitment hospital [3]
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Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre - Heidelberg West
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Recruitment hospital [4]
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Australian Alzheimer's Research Foundation - Nedlands
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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5011 - Woodville
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Recruitment postcode(s) [3]
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3081 - Heidelberg West
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment outside Australia
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California
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Florida
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Indiana
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Louisiana
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Michigan
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Ciudad Autonoma Buenos Aires
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Alicante
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Samsun
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Preston
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Sheffield
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Funding & Sponsors
Primary sponsor type
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Hoffmann-La Roche
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Summary
Brief summary
Part 1 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study
will evaluate the efficacy and safety of gantenerumab in participants with mild Alzheimer
disease. Participants will be randomized to receive either gantenerumab subcutaneously every
4 weeks or placebo subcutaneously every 4 weeks. Approved Alzheimer medication is allowed if
on stable dose for 3 months prior to screening. Part 2 is an open-label extension (OLE).
A positron emission tomography (PET) imaging substudy will be conducted within the main
study. Eligible participants who provide separate informed consent will undergo PET imaging
scans using the radioligand florbetapir as a pharmacodynamic measure of changes in brain
amyloid load over time.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02051608
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Hoffmann-La Roche
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02051608
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