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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/NCT05256134
Registration number
NCT05256134
Ethics application status
Date submitted
25/01/2022
Date registered
25/02/2022
Date last updated
18/04/2023
Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease (AD)
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Scientific title
A Phase III, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease
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Secondary ID [1]
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2021-001184-25
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Secondary ID [2]
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WN42444
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Universal Trial Number (UTN)
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Trial acronym
SKYLINE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimers 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
Experimental: Gantenerumab - Gantenerumab will be administered as subcutaneous (SC) injection with gradual uptitration.
Placebo Comparator: Placebo - Placebo will be administered as SC injection with gradual uptitration.
Treatment: Drugs: Gantenerumab
Gantenerumab will be administered as per the dosing schedule described in the Arm description.
Treatment: Drugs: Placebo
Placebo will be administered as per the dosing schedule described in the Arm description.
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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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Change from Baseline to Year 4 in Preclinical Alzheimer's Cognitive Composite-5 (PACC-5) Score
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Assessment method [1]
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Timepoint [1]
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Baseline up to Week 211
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Secondary outcome [1]
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Time from Randomization to Clinical Progression to Mild Cognitive Impairment (MCI) or Dementia due to AD
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Assessment method [1]
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Timepoint [1]
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Baseline up to Week 211
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Secondary outcome [2]
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Time to Onset of Confirmed Clinical Progression
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Assessment method [2]
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Timepoint [2]
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Baseline up to Week 211
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Secondary outcome [3]
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Change from Baseline to Year 4 in the Amsterdam Instrumental Activities of Daily Living Questionnaire Short Version (A-IADL-Q-SV)
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Assessment method [3]
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Timepoint [3]
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Baseline up to Week 211
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Secondary outcome [4]
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Change from Baseline to Year 4 in the Cognitive Function Instrument Acute (CFIa)
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Assessment method [4]
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Timepoint [4]
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Baseline up to Week 211
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Secondary outcome [5]
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Change from Baseline to Year 4 in the Clinical Dementia Rating Sum of Boxes (CDR-SB)
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Assessment method [5]
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Timepoint [5]
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Baseline up to Week 211
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Secondary outcome [6]
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Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
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Assessment method [6]
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Timepoint [6]
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Baseline up to Week 211
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Secondary outcome [7]
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Number of Participants with Anti-Drug Antibodies (ADAs)
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Assessment method [7]
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Timepoint [7]
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Baseline up to Week 211
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Secondary outcome [8]
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Change in Brain Amyloid Load Over Time in a Subset of Partcipants
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Assessment method [8]
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Timepoint [8]
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Baseline up to Week 211
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Secondary outcome [9]
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Change in Brain Tau Load Over Time in a Subset of Partcipants
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Assessment method [9]
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Timepoint [9]
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Baseline up to Week 211
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Secondary outcome [10]
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Change in Cerebrospinal Fluid (CSF) Abeta 1-42 Over Time in a Subset of Participants
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Assessment method [10]
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Timepoint [10]
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Baseline up to Week 211
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Secondary outcome [11]
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Change in CSF Abeta 1-40 Over Time in a Subset of Partcipants
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Assessment method [11]
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Timepoint [11]
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Baseline up to Week 211
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Secondary outcome [12]
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Change in CSF Neurofilament Light (NfL) Over Time in a Subset of Participants
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Assessment method [12]
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Timepoint [12]
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Baseline up to Week 211
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Secondary outcome [13]
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Change in CSF Phosphorylated Tau (pTau) Over Time in a Subset of Participants
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Assessment method [13]
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Timepoint [13]
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Baseline up to Week 211
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Secondary outcome [14]
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Change in CSF Total Tau (tTau) Over Time in a Subset of Participants
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Assessment method [14]
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Timepoint [14]
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Baseline up to Week 211
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Secondary outcome [15]
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Change in Blood Abeta 1-42 Over Time
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Assessment method [15]
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Timepoint [15]
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Baseline up to Week 211
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Secondary outcome [16]
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Change in Blood Abeta 1-40 Over Time
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Assessment method [16]
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Timepoint [16]
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Baseline up to Week 211
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Secondary outcome [17]
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Change in Blood NfL Over Time
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Assessment method [17]
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Timepoint [17]
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Baseline up to Week 211
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Secondary outcome [18]
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Change in Blood pTau Over Time
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Assessment method [18]
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Timepoint [18]
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Baseline up to Week 211
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Secondary outcome [19]
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Change in Whole Brain Volume as Determined by Magnetic Resonance Imaging (MRI)
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Assessment method [19]
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Timepoint [19]
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Baseline up to Week 211
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Secondary outcome [20]
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Change in Ventricle Volume as Determined by MRI
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Assessment method [20]
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Timepoint [20]
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Baseline up to Week 211
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Secondary outcome [21]
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Change in Hippocampal Volume as Determined by MRI
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Assessment method [21]
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Timepoint [21]
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Baseline up to Week 211
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Eligibility
Key inclusion criteria
Key
- Willing and able to comply with the study protocol and complete all aspects of the
study [including cognitive and functional assessments, physical and neurological
examinations, MRI, CSF collection, genotyping, and positron emission tomography (PET)
imaging].
- Cognitively unimpaired with a screening clinical dementia rating global score (CDR-GS)
of 0, and Repeatable Battery for the Assessment of Neuropsychological Status Delayed
Memory Index (RBANS DMI) >=80.
- Evidence of cerebral amyloid accumulation.
- Participants who have an available person (referred to as a "study partner").
- Fluent in the language of the tests used at the study site.
- Adequate visual and auditory acuity, sufficient to perform neuropsychological testing
(eye glasses and hearing aids are permitted).
- Agreed not to participate in other interventional research studies for the duration of
this trial.
- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraceptive methods that result in a failure rate
of <1% per year during the treatment period and for at least 17 weeks after the final
dose of study treatment.
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Minimum age
60
Years
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Maximum age
80
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
- Any evidence of an underlying neurological or neurodegenerative condition that may
lead to cognitive impairment other than AD.
- Clinical diagnosis of mild cognitive impairment (MCI), prodromal AD, or any form of
dementia.
- History or presence of intracranial or intracerebral vascular malformations, aneurysm,
subarachnoid hemorrhage, or intracerebral macrohemorrhage.
- History or presence of posterior reversible encephalopathy syndrome.
- History of ischemic stroke with clinical symptoms or an acute event that is consistent
with a transient ischemic attack within 12 months of screening.
- History of severe, clinically significant (i.e., resulting in persistent neurologic
deficit or structural brain damage) central nervous system (CNS) trauma (e.g.,
cerebral contusion).
- History or presence of intracranial mass lesion (e.g., glioma, meningioma) that could
potentially impair cognition or lead to progressive neurological deficits.
- Infections that may affect brain function or a history of infections that resulted in
neurologic sequelae [e.g., human immunodeficiency virus (HIV), syphilis,
neuroborreliosis, and viral or bacterial meningitis and encephalitis].
- History of major depression, schizophrenia, schizoaffective disorder, or bipolar
disorder.
- At risk for suicide.
- History of alcohol and/or substance abuse or dependence.
- History or presence of clinically significant systemic vascular disease, atrial
fibrillation or heart failure.
- Within the last year, experienced unstable or clinically significant cardiovascular
disease (e.g., myocardial infarction).
- Uncontrolled hypertension.
- Chronic kidney disease, indicated by creatinine clearance <30 mL/min.
- Confirmed and unexplained impaired hepatic function.
- History of, or are known to currently have an HIV infection, or hepatitis B or
hepatitis C virus infection that has not been adequately treated.
- History or presence of systemic autoimmune disorders that may lead to progressive
neurological impairment with associated cognitive deficits.
- Systemic immunosuppression or immunomodulation due to the continuing effects of
immunosuppressant or immunomodulating medications.
- Current COVID-19 infection.
- Evidence of folic acid or vitamin B-12 deficiency.
- Any passive immunotherapy (Ig) or other long-acting biologic agent to prevent or
postpone cognitive decline within 1 year of screening.
- Any other investigational treatment within 5 half-lives or 6 months (whichever is
longer) prior to screening.
- Typical/Atypical anti-psychotic medications or neuroleptic medications.
- Anticoagulation medications within 3 months of screening with no plans to initiate any
prior to randomization.
- Any previous treatment with cholinesterase inhibitors and N-methyl-D-aspartate
receptor antagonists are exclusionary at screening.
- Pregnant or breastfeeding, or intending to become pregnant during the study or within
17 weeks after the final dose of gantenerumab.
- Impaired coagulation.
- Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric, human, or humanized antibodies or fusion proteins, including gantenerumab
and gantenerumab excipients.
- Participants who reside in a skilled nursing facility such as a convalescent home or
long-term care facility.
- Participants who require residence in such facilities during the study may continue in
the study and be followed for efficacy and safety, provided that they have a study
partner who meets the study partner requirements.
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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
Terminated
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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
19/04/2022
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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
10/03/2023
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Sample size
Target
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Accrual to date
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Final
24
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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KaRa Institute of Neurological Diseases - Macquarie Park
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Recruitment hospital [2]
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Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre - Heidelberg West
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Recruitment hospital [3]
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Australian Alzheimer's Research Foundation - Nedlands
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Recruitment postcode(s) [1]
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2113 - Macquarie Park
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Recruitment postcode(s) [2]
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3081 - Heidelberg West
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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California
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United States of America
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Florida
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Country [4]
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United States of America
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State/province [4]
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Georgia
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Country [5]
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United States of America
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State/province [5]
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Illinois
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Country [6]
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United States of America
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State/province [6]
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Kansas
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Country [7]
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United States of America
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State/province [7]
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Louisiana
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Country [8]
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United States of America
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State/province [8]
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Michigan
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Country [9]
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United States of America
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State/province [9]
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Nebraska
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United States of America
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State/province [10]
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New Jersey
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United States of America
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State/province [11]
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New York
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Country [12]
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United States of America
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State/province [12]
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North Carolina
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United States of America
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Ohio
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Country [14]
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United States of America
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Oregon
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Country [15]
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United States of America
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Pennsylvania
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Country [16]
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United States of America
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State/province [16]
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Texas
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United States of America
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State/province [17]
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Virginia
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Country [18]
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Argentina
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State/province [18]
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Ciudad Autonoma Buenos Aires
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Country [19]
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Argentina
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State/province [19]
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Córdoba
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Country [20]
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Argentina
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State/province [20]
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Mendoza
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Canada
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State/province [21]
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British Columbia
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Country [22]
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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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Country [24]
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Canada
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Quebec
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Italy
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Lazio
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Italy
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Lombardia
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Italy
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Molise
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Italy
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State/province [28]
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Umbria
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Korea, Republic of
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Busan
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Poland
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State/province [32]
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Bia?ystok
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Poland
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Bydgoszcz
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Poland
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Pozna?
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Sopot
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Poland
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Szczecin
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Poland
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Wroc?aw
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Spain
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Madrid
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Spain
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Barcelona
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Spain
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Sevilla
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Sweden
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Mölndal
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Sweden
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Stockholm
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United Kingdom
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Birmingham
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United Kingdom
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Exeter
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United Kingdom
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Sheffield
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United Kingdom
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Southampton
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United Kingdom
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Swindon
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A study to evaluate the efficacy and safety of gantenerumab in amyloid-positive, cognitively
unimpaired participants at risk for or at the earliest stages of AD. The planned number of
participants for this study is approximately 1200 participants randomized in a 1:1 ratio to
receive either gantenerumab or placebo (600 participants randomized to gantenerumab and 600
participants randomized to placebo).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05256134
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-La Roche
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Fax
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Email
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Contact person for public queries
Name
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05256134
Download to PDF