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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05310071
Registration number
NCT05310071
Ethics application status
Date submitted
25/03/2022
Date registered
4/04/2022
Date last updated
23/04/2025
Titles & IDs
Public title
A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease
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Scientific title
A Phase 3b/4 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Verify the Clinical Benefit of Aducanumab (BIIB037) in Participants With Alzheimer's Disease
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Secondary ID [1]
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2022-001671-14
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Secondary ID [2]
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221AD305
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Universal Trial Number (UTN)
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Trial acronym
ENVISION
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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 - Aducanumab
Treatment: Drugs - Placebo
Experimental: Aducanumab - Participants will receive aducanumab, up to 10 milligrams per kilogram (mg/kg), monthly (once every four weeks), administered as intravenous (IV) infusion.
Placebo comparator: Placebo - Participants will receive placebo, monthly (once every four weeks), administered as IV infusion.
Treatment: Drugs: Aducanumab
Administered as specified in the treatment arm.
Treatment: Drugs: Placebo
Administered as specified in the treatment arm.
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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 in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 78
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Assessment method [1]
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The Clinical Dementia Rate Scale integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following the caregiver interview and systematic participant examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. The "Sum of boxes" scoring methodology sums the score for each of the 6 domains and provides a value ranging from 0 to 18. Higher scores indicate greater impairment. A positive change from baseline indicates greater impairment.
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Timepoint [1]
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Baseline, Week 78
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Secondary outcome [1]
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Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score at Weeks 78 and 106
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Assessment method [1]
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The iADRS composite captures a decline in both cognition and daily function. It is a simple linear combination of the Alzheimer's disease assessment scale, cognitive subscale (ADAS-Cog13), and the Alzheimer's disease cooperative study scale for activities of daily living in mild cognitive impairment (ADCS-ADL-MCI). The ADAS-Cog13 scale ranges from 0 to 85 (higher scores indicate worse performance) and the ADCS-ADL-MCI scale ranges from 0 to 53 (higher scores indicate greater independent, healthy functioning). The total score for iADRS scale ranges from 0 to 138, where higher scores indicate better performance.
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Timepoint [1]
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Baseline, Weeks 78 and 106
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Secondary outcome [2]
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Change From Baseline in Alzheimer's Disease Cooperative Study for Activities of Daily Living in Mild Cognitive Impairment (ADCS-ADL-MCI) Scale Score at Weeks 78 and 106
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Assessment method [2]
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The ADCS-ADL-MCI scale consists of 17 instrumental items (e.g., shopping, preparing meals, using household appliances, etc) and 1 basic item (getting dressed). Ratings reflect caregiver observations about the participant's actual functioning over the previous month and provide an assessment of change in the functional state of the participant over time. The total score ranges from 0 to 53. Higher scores indicate greater independent, healthy functioning. A positive change from baseline indicates healthy functioning while a negative change from baseline indicates a decline in independent functioning.
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Timepoint [2]
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Baseline, Weeks 78 and 106
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Secondary outcome [3]
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Change From Baseline in Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog13) at Weeks 78 and 106
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Assessment method [3]
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ADAS-Cog13 comprises both cognitive tasks and clinical ratings of cognitive performance. The cognitive subscale items capture word recall, ability to follow commands, the ability to correctly copy or draw an image, naming, the ability to interact with everyday objects, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure for delayed word recall and concentration/distractibility. The total score ranges from 0 to 85. Higher scores indicate worse performance. A positive change from baseline indicates decline in cognitive performance.
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Timepoint [3]
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Baseline, Weeks 78 and 106
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Secondary outcome [4]
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Change From Baseline in Mini-Mental State Examination (MMSE) Scale Score at Weeks 78 and 106
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Assessment method [4]
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The MMSE scale is a performance-based test of global cognitive status. It consists of 11 tasks that assess orientation, word recall, attention and calculation, language abilities, and visuospatial functions. The scores from the 11 tests are combined to obtain the total score, which ranges from 0 to 30. Higher scores indicate better performance. A negative change from baseline indicates decline in cognitive performance.
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Timepoint [4]
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Baseline, Weeks 78 and 106
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Secondary outcome [5]
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Change From Baseline in Neuropsychiatric Inventory-10 (NPI-10) Score at Weeks 78 and 106
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Assessment method [5]
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The NPI-10 is a questionnaire administered to the informant, designed to obtain information on the presence of neuropsychiatric symptoms and behaviors in a participant with Alzheimer's disease. Ten areas are assessed: delusions, hallucinations, agitation/aggression, depression, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability and aberrant motor behavior. The NPI total score ranges from 0 to 120. Higher scores indicate greater impairment. A negative change from baseline indicates improvement (symptom reduction).
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Timepoint [5]
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Baseline, Weeks 78 and 106
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Secondary outcome [6]
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Change From Baseline in Amyloid Positron Emission Tomography (PET) Signal at Weeks 78 and 104
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Assessment method [6]
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Amyloid PET scan assesses cerebral amyloid load using radiotracers which is standardized into centiloids. Centiloid values on centiloid scale is based on mean composite standardized uptake value ratio (SUVR).
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Timepoint [6]
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Baseline, Weeks 78 and 104
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Secondary outcome [7]
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Change From Baseline in Tau PET Signal at Weeks 78 and 104
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Assessment method [7]
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The cerebral tau level was measured by tau PET imaging. Tau PET imaging was conducted using radiotracer. SUVR is a ratio of PET uptake measured in brain region of interest and a disease-free reference region. A higher SUVR is an indication of increased PET radiotracer uptake and worsening disease.
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Timepoint [7]
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Baseline, Weeks 78 and 104
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Secondary outcome [8]
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Change From Baseline in CDR-SB Score at Week 106
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Assessment method [8]
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The CDR integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following caregiver interview and systematic participant examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. The CDR-SB sums the score for each of the 6 domains and provides a value ranging from 0 to 18. Higher scores indicate greater impairment. Positive change from baseline indicates greater impairment.
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Timepoint [8]
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Baseline, Week 106
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Secondary outcome [9]
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Change From Baseline in Global Statistical Test (GST) Composite Z-Score at Weeks 78 and 106
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Assessment method [9]
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GST z-score is an average of z-scores of CDR-SB, ADASCog13 and ADCS-ADL-MCI. CDR-SB assesses 3 cognitive (memory,orientation, judgment/problem-solving)and 3 functional(community affairs,home/hobbies,personal care) domains. Sum of Boxes method combines scores across 6 domains, ranging from 0-18(higher scores=greater impairment). ADAS-Cog13 evaluates cognitive tasks like word recall, naming, orientation and memory, with scores from 0-85 (higher scores=worse performance). ADCS-ADL-MCI rates 17 tasks (e.g.,shopping, preparing meal) and 1 basic task(dressing) with scores from 0-53 (higher scores=greater independence/healthy functioning). z-score\>0 indicates greater impairment/worse performance for CDR-SB and ADASCog13 scales and improved functioning for ADCS-ADL-MCI. For ADCS-ADL-MCI, z-score were reversed (new reversed value=original value-1) to make interpretation consistent. The GST z-score of 0 indicates population mean and score\>0 indicate greater impairment/worse performance.
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Timepoint [9]
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Baseline, Weeks 78 and 106
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Eligibility
Key inclusion criteria
Key
* The participant must have confirmed amyloid beta pathology by cerebrospinal fluid (CSF) or amyloid PET
* Must have a history of subjective memory decline with gradual onset and slow progression over the 6 months before Screening, confirmed by study partner
* The participant must have 1 informant/care partner who, in the Investigator's opinion, has frequent and sufficient contact with the participant (at least 10 hours/week in person or by phone) as to be able to provide accurate information about the participant's cognitive and functional abilities over time
* Must meet all of the following clinical criteria for MCI due to Alzheimer's disease or mild Alzheimer's disease according to National Institute on Aging and Alzheimer's Association (NIA-AA) criteria
1. Have an MMSE score between 22 and 30 inclusive
2. Have a CDR memory score >0.5
3. Have a Clinical Dementia Rating Scale Global Score (CDR-GS) of 0.5 or 1.0
4. Have a Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score of 85 or lower indicative of objective cognitive impairment
* Apart from a clinical diagnosis of early Alzheimer's disease, the participant must be in good health as determined by the Investigator based on medical history and screening assessments
* Must consent to apolipoprotein E (ApoE) genotyping. (Note: Participants are not required to be ApoE e4 carriers)
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Minimum age
60
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Maximum age
85
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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 uncontrolled medical or neurological/neurodegenerative condition (other than Alzheimer's disease) that, in the opinion of the Investigator, might be a contributing cause of the participant's cognitive impairment
* Clinically significant and/or unstable psychiatric illness within 6 months prior to Screening
* Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening
* History of severe allergic or anaphylactic reactions or of hypersensitivity to any of the inactive ingredients in the drug product
* Participation in any study with purported disease-modifying effect in Alzheimer's disease within 12 months prior to Screening unless documentation of receipt of placebo is available
* Current use or previous use of medications with a purported disease-modifying effect in Alzheimer's disease, outside of investigational studies
* Use of any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, put the participant at higher risk for AEs, or impair the participant's ability to perform cognitive testing or complete study procedures
* Use of any investigational drug
* Prior exposure to aducanumab either commercially or by participation in a previous study with aducanumab. (Participants are eligible if they did not receive active aducanumab.)
* A negative PET scan result with any amyloid-targeting ligand within 12 months prior to Screening
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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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 administering the treatment/s
The people assessing the outcomes
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
Stopped early
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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
2/06/2022
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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
12/08/2024
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Sample size
Target
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Accrual to date
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Final
1027
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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St Vincent's Hospital Sydney - Darlinghurst
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KaRa Institute of Neurological Diseases - Macquarie Park
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Box Hill Hospital - Box Hill
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Frankston Hospital - Frankston
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Austin Health - Heidelberg
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The Alfred Hospital - Melbourne
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Royal Melbourne Hospital - Parkville
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Recruitment hospital [8]
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Australian Alzheimer's Research Foundation - Nedlands
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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2113 - Macquarie Park
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3128 - Box Hill
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3199 - Frankston
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3084 - Heidelberg
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3004 - Melbourne
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3050 - Parkville
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Recruitment postcode(s) [8]
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6009 - Nedlands
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Recruitment outside Australia
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Bristol
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Funding & Sponsors
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Commercial sector/industry
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Name
Biogen
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Summary
Brief summary
The primary objective of this study is to verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score as compared with placebo in participants with early Alzheimer's disease.
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Trial website
https://clinicaltrials.gov/study/NCT05310071
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Biogen
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Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/71/NCT05310071/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/71/NCT05310071/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT05310071
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