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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/NCT05310071
Registration number
NCT05310071
Ethics application status
Date submitted
25/03/2022
Date registered
4/04/2022
Date last updated
12/02/2024
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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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 kilograms (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 CDR-SB Score at Week 78
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Assessment method [1]
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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 "Sum of boxes" scoring methodology (CDR-SB) sums the score for each of the 6 domains and provides a value ranging from 0 to 18 with higher scores indicating greater impairment. 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 decline in both cognition and daily function. The iADRS is a simple linear combination of 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 iADRS scale ranges from 0-138, higher scores indicating 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 ADCS-ADL-MCI Score at Weeks 78 and 106
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Assessment method [2]
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The ADCS-ADL-MCI is a functional evaluation scale for MCI participants, based on information provided by an informant who rates 18 areas of daily living, with total score ranging from 0-53. Higher scores indicate greater independent, healthy functioning. Positive change from baseline indicates healthy 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 ADAS-Cog13 Score at Weeks 78 and 106
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Assessment method [3]
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The ADCS-ADAS-Cog13 is a brief objective cognitive assessment of the severity of cognitive symptoms of Alzheimer's disease. The ADAS-Cog13 score ranges from 0 to 85, with higher scores indicating worse 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) Score at Weeks 78 and 106
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Assessment method [4]
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The MMSE is a brief cognitive screening tool that provides clinicians the ability to rapidly assess cognitive ability in less than 10 minutes. The MMSE score ranges from 0-30, with higher scores indicating better 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 indicates greater impairment.
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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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The cerebral amyloid plaque level was measured by amyloid PET imaging.
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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.
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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 "Sum of boxes" scoring methodology (CDR-SB) sums the score for each of the 6 domains and provides a value ranging from 0 to 18 with higher scores indicating 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
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Assessment method [9]
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The GST is a composite z-score defined as the average of standardized z-scores of the CDR-SB, ADASCog13, and ADCS-ADL-MCI. A positive change from baseline indicates improvement.
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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)
Key
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Minimum age
60
Years
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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
Active, not recruiting
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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
31/10/2026
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Actual
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Sample size
Target
1512
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Accrual to date
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Final
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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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Recruitment hospital [2]
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KaRa Institute of Neurological Diseases - Macquarie Park
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Recruitment hospital [3]
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Box Hill Hospital - Box Hill
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Recruitment hospital [4]
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Austin Health - Heidelberg
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Recruitment hospital [5]
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The Alfred Hospital - Melbourne
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Recruitment hospital [6]
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Royal Melbourne Hospital - Parkville
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Recruitment hospital [7]
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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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Recruitment postcode(s) [2]
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2113 - Macquarie Park
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Recruitment postcode(s) [3]
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3128 - Box Hill
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment postcode(s) [6]
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3050 - Parkville
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment outside Australia
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Connecticut
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State/province [99]
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Oeste
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Country [100]
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Portugal
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Braga
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Country [101]
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Spain
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State/province [101]
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Córdoba
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Country [102]
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Spain
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State/province [102]
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Guipuzcoa
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Country [103]
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Spain
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State/province [103]
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Navarra
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Country [104]
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Spain
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State/province [104]
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Barcelona
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Country [105]
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Spain
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State/province [105]
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Lleida
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Country [106]
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Spain
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State/province [106]
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Madrid
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Country [107]
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Spain
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State/province [107]
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Sevilla
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Country [108]
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Spain
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State/province [108]
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Valencia
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Country [109]
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Sweden
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State/province [109]
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Scania
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Country [110]
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Sweden
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State/province [110]
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Västra Götaland
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Country [111]
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Sweden
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State/province [111]
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Stockholm
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Country [112]
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United Kingdom
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State/province [112]
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Greater London
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United Kingdom
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State/province [113]
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Hampshire
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Country [114]
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United Kingdom
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State/province [114]
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Lothian Region
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Country [115]
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United Kingdom
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State/province [115]
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Strathclyde
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Country [116]
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United Kingdom
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State/province [116]
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Bristol
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Biogen
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Ethics approval
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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/ct2/show/NCT05310071
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Public notes
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Contacts
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Medical Director
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Biogen
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05310071
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