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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04241068
Registration number
NCT04241068
Ethics application status
Date submitted
22/01/2020
Date registered
27/01/2020
Titles & IDs
Public title
A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205
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Scientific title
Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (Aducanumab) in Subjects With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205
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Secondary ID [1]
0
0
2019-004368-22
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Secondary ID [2]
0
0
221AD304
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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
0
0
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Condition category
Condition code
Neurological
0
0
0
0
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Alzheimer's disease
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Neurological
0
0
0
0
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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
Experimental: Aducanumab - Participants will be administered aducanumab 10 milligrams per kilogram (mg/kg) by intravenous (IV) infusions every four weeks (Q4W) for a duration of 100 weeks during the Core Treatment Period. Eligible participants will continue to receive aducanumab 10 mg/kg IV infusion, Q4W, for 52 weeks during the Long-Term Extension (LTE) Treatment Period.
Treatment: Drugs: Aducanumab
Administered as specified in the treatment arm.
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Intervention code [1]
0
0
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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Core Treatment Period: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [1]
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0
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A SAE is any untoward medical occurrence that at any dose results in death, life-threatening event, requires inpatient hospitalization, significant disability/incapacity or congenital anomaly.
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Timepoint [1]
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Up to Week 100
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Primary outcome [2]
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Core Treatment Period: Number of Participants with AEs Leading to Treatment Discontinuation or Study Withdrawal
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Assessment method [2]
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0
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
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Timepoint [2]
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0
Up to Week 100
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Primary outcome [3]
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Core Treatment Period: Number of Participants with Amyloid-related Imaging Abnormality-Edema (ARIA-E)
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Assessment method [3]
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Magnetic resonance imaging (MRI) readings will be used to assess ARIA-E severity as mild, moderate and severe.
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Timepoint [3]
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Up to Week 100
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Primary outcome [4]
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Core Treatment Period: Number of Participants with Amyloid-related Imaging Abnormality- Hemorrhage or Superficial Siderosis (ARIA-H)
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Assessment method [4]
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MRI readings will be used to assess severity of ARIA-H microhemorrhages and superficial siderosis.
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Timepoint [4]
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Up to Week 100
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Primary outcome [5]
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Core Treatment Period: Number of Participants With Antidrug Antibodies (ADAs) in Serum
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Assessment method [5]
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Presence of serum ADAs will be determined using a validated assay.
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Timepoint [5]
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Up to Week 100
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Eligibility
Key inclusion criteria
Key
Core Treatment Period:
* Participant was participating in an aducanumab clinical study at the time of the announcement of early termination (feeder studies).
* Has one care partner who, in the Investigator's opinion, has adequate contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities.
LTE Treatment Period:
* Participant must have completed the Core study period (Week 102) and adequately tolerated 10 mg/kg of aducanumab during the Core study period in the opinion of the Investigator.
* Has one informant/care partner who, in the Investigator's opinion, has frequent and sufficient contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities.
Key
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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
Core Treatment Period:
* Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the participant's cognitive impairment.
* Stroke or any unexplained loss of consciousness within 1 year prior to Screening.
* Clinically significant unstable psychiatric illness in past 6 months.
* History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to Screening.
* A seizure event that occurred after the last visit of the feeder study and before Screening for this study.
* Evidence of impaired liver function as shown by an abnormal liver function profile at Screening.
* History of or known seropositivity for HIV.
* Clinically significant systemic illness or serious infection within 30 days prior to or during Screening.
* Contraindications to having a brain magnetic resonance imaging (MRI).
LTE Treatment Period:
* Any medical or psychiatric contraindication or clinically significant abnormality that, in the opinion of the Investigator, will substantially increase the risk associated with the participant's enrollment in and completion of the study.
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
NA
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
2/03/2020
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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
22/07/2024
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Sample size
Target
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Accrual to date
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Final
1696
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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The Prince Charles Hospital - Chermside
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St Vincent's Hospital Sydney - Darlinghurst
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Central Coast Neurosciences Research (Erina) - Erina
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KaRa Institute of Neurological Diseases - Macquarie Park
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Box Hill Hospital - Box Hill
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Austin Health - Heidelberg West
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Royal Melbourne Hospital - Parkville
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Australian Alzheimer's Research Foundation - Nedlands
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4032 - Chermside
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2010 - Darlinghurst
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2250 - Erina
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2113 - Macquarie Park
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3128 - Box Hill
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3081 - Heidelberg West
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3050 - Parkville
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6009 - Nedlands
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State/province [120]
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Sopot
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Poland
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Szczecin
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Poland
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Warszawa
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Poland
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Wroclaw
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Portugal
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Braga
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Portugal
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Coimbra
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Portugal
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Loures
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Country [127]
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Portugal
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Torres Vedras
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Spain
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State/province [128]
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Alicante
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Country [129]
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Spain
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Córdoba
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Spain
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Guipuzcoa
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Spain
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Navarra
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Country [132]
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Spain
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Vizcaya
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Spain
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Barcelona
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Spain
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Lleida
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Country [138]
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Sweden
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Malmö
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Sweden
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State/province [139]
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Mölndal
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Sweden
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Stockholm
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Sweden
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Uppsala
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Switzerland
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Biel/Bienne
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Switzerland
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Genève
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Switzerland
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Lausanne
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Switzerland
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Lugano
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Switzerland
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Schlieren
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Taiwan
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Changhua
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Taiwan
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State/province [148]
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Kaohsiung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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State/province [151]
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Taoyuan City
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United Kingdom
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State/province [152]
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Greater London
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United Kingdom
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State/province [153]
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Greater Manchester
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United Kingdom
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Lothian Region
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United Kingdom
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Somerset
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United Kingdom
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Strathclyde
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United Kingdom
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Tayside Region
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Country [158]
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United Kingdom
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Tyne & Wear
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Biogen
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective is to evaluate the safety and tolerability of aducanumab over 100 weeks of treatment after a wash-out period imposed by discontinuation of feeder studies in participants who had previously received aducanumab (i.e. previously treated participants) or who had previously received placebo (i.e. treatment-naïve participants).
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Trial website
https://clinicaltrials.gov/study/NCT04241068
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Medical Director
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Address
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Biogen
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04241068