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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03712787




Registration number
NCT03712787
Ethics application status
Date submitted
18/10/2018
Date registered
19/10/2018

Titles & IDs
Public title
An Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD)
Scientific title
An Extension Study of ABBV-8E12 in Early Alzheimer's Disease
Secondary ID [1] 0 0
2018-000268-26
Secondary ID [2] 0 0
M15-570
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Study Drug, and Fatal TEAEs
Timepoint [1] 0 0
From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Primary outcome [2] 0 0
Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values
Timepoint [2] 0 0
Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Primary outcome [3] 0 0
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values
Timepoint [3] 0 0
Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Primary outcome [4] 0 0
Columbia-Suicide Severity Rating Scale (C-SSRS) During Double-Blind Treatment Period
Timepoint [4] 0 0
Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Primary outcome [5] 0 0
Brain Magnetic Resonance Imaging (MRI) Results: Number of Participants With Cerebral Edemas, New Microhemorrhage(s), and Severe White Matter Disease
Timepoint [5] 0 0
Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.

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
Minimum age
57 Years
Maximum age
88 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2021
Sample size
Target
Accrual to date
Final
364
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Centre for Applied Medical Research /ID# 204903 - Darlinghurst
Recruitment hospital [2] 0 0
Griffith University /ID# 204905 - Southport
Recruitment hospital [3] 0 0
Austin Health /ID# 204906 - Heidelberg
Recruitment hospital [4] 0 0
Australian Alzheimer's Res Fou /ID# 204904 - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4222 - Southport
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
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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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Massachusetts
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United States of America
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Mississippi
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United States of America
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New Jersey
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New York
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North Carolina
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Oregon
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Pennsylvania
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Rhode Island
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Tennessee
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Texas
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Utah
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United States of America
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Virginia
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Belgium
State/province [21] 0 0
Bruxelles-Capitale
Country [22] 0 0
Belgium
State/province [22] 0 0
Vlaams-Brabant
Country [23] 0 0
Belgium
State/province [23] 0 0
Liege
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Denmark
State/province [25] 0 0
Hovedstaden
Country [26] 0 0
Finland
State/province [26] 0 0
Varsinais-Suomi
Country [27] 0 0
Finland
State/province [27] 0 0
Kuopio
Country [28] 0 0
Italy
State/province [28] 0 0
Emilia-Romagna
Country [29] 0 0
Italy
State/province [29] 0 0
Lazio
Country [30] 0 0
Italy
State/province [30] 0 0
Umbria
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Italy
State/province [31] 0 0
Brescia
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Italy
State/province [32] 0 0
Milano
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Italy
State/province [33] 0 0
Milan
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New Zealand
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Burwood
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Spain
State/province [35] 0 0
Pais Vasco
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Spain
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Barcelona
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Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
Sweden
State/province [38] 0 0
Stockholms Lan
Country [39] 0 0
Sweden
State/province [39] 0 0
Vastra Gotalands Lan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing, please refer to the link below.
Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03712787