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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/NCT03712787
Registration number
NCT03712787
Ethics application status
Date submitted
18/10/2018
Date registered
19/10/2018
Date last updated
22/09/2022
Titles & IDs
Public title
An Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD)
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Scientific title
An Extension Study of ABBV-8E12 in Early Alzheimer's Disease
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Secondary ID [1]
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2018-000268-26
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Secondary ID [2]
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M15-570
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tilavonemab
Experimental: 300 mg/1000 mg Tilavonemab - Participants who received 300 mg tilavonemab in Study M15-566 receive 1000 mg tilavonemab in Study M15-570 via intravenous (IV) infusion every 4 weeks for up to 5.5 years.
Experimental: 1000 mg/1000 mg Tilavonemab - Participants who received 1000 mg tilavonemab in Study M15-566 continue on the same dose in Study M15-570 via IV infusion every 4 weeks for up to 5.5 years.
Experimental: 2000 mg/2000 mg Tilavonemab - Participants who received 2000 mg tilavonemab in Study M15-566 continue on the same dose in Study M15-570 via IV infusion every 4 weeks for up to 5.5 years.
Experimental: PBO/2000 mg Tilavonemab - Participants who received placebo (PBO) in Study M15-566 receive 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks for up to 5.5 years.
Treatment: Drugs: Tilavonemab
solution for IV infusion
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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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Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Study Drug, and Fatal TEAEs
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Assessment method [1]
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Treatment emergent adverse events (TEAEs) are defined as any adverse event (AE) from the time of study drug administration until 20 weeks after discontinuation of study drug. An AE is defined as any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious AE (SAE) is defined as any event that: results in death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent serious outcome. Severity of AEs was categorized as mild, moderate, or severe. Relationship of the AE to the study treatment was categorized as having a reasonable possibility or no reasonable possibility.
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Timepoint [1]
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From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
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Primary outcome [2]
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Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values
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Assessment method [2]
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Clinical laboratory PCS criteria were adapted from National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
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Timepoint [2]
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Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
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Primary outcome [3]
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Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values
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Assessment method [3]
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Clinical laboratory PCS criteria were adapted from NCI CTCAE version 4.03
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Timepoint [3]
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Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
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Primary outcome [4]
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Columbia-Suicide Severity Rating Scale (C-SSRS) During Double-Blind Treatment Period
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Assessment method [4]
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The C-SSRS is a systematically administered instrument developed to track suicidal adverse events across a treatment study. The instrument is designed to assess suicidal behavior and ideation, track and assess all suicidal events, as well as the lethality of attempts. Suicidal ideation categories include the following: wish to be dead; nonspecific active suicidal thoughts; active suicidal ideation without intent to act; active suicidal ideation with some intent to act but no plan; active suicidal ideation with plan and intent. Suicidal behavior categories include the following: actual attempt; interrupted attempt; aborted attempt; preparatory acts or behavior; suicidal behavior; completed suicide.
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Timepoint [4]
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Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
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Primary outcome [5]
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Brain Magnetic Resonance Imaging (MRI) Results: Number of Participants With Cerebral Edemas, New Microhemorrhage(s), and Severe White Matter Disease
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Assessment method [5]
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Timepoint [5]
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Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
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Eligibility
Key inclusion criteria
- All subjects with early AD who complete Study M15-566 (NCT02880956), meet all
inclusion criteria, and do not meet any exclusion criteria are eligible for enrollment
- Subject was compliant during participation in Study M15-566 (NCT02880956)
- Subject has an identified, reliable study partner who has frequent contact with the
subject and who will provide information as to the subject's cognitive and functional
abilities
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Minimum age
57
Years
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Maximum age
88
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
- The subject has any significant change in his/her medical condition since
participation in Study M15-566 (NCT02880956) that could interfere with the subject's
participation in Study M15-570, could place the subject at increased risk, or could
confound interpretation of study results
- More than 8 weeks have elapsed since the subject received his/her last dose of study
drug in Study M15-566 (NCT02880956)
- The subject is concurrently enrolled in another interventional clinical study
involving a therapeutic agent with the exception of Study M15-566 (NCT02880956)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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 2
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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
22/03/2019
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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
30/09/2021
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Sample size
Target
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Accrual to date
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Final
364
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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St Vincent's Centre for Applied Medical Research /ID# 204903 - Darlinghurst
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Recruitment hospital [2]
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Griffith University /ID# 204905 - Southport
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Recruitment hospital [3]
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Austin Health /ID# 204906 - Heidelberg
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Recruitment hospital [4]
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Australian Alzheimer's Res Fou /ID# 204904 - 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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4222 - Southport
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Recruitment postcode(s) [3]
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3084 - Heidelberg
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Arizona
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Burwood
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Stockholms Lan
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Sweden
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Vastra Gotalands Lan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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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
The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in
participants with early AD.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03712787
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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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ABBVIE INC.
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Address
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AbbVie
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03712787
Download to PDF