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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02880956




Registration number
NCT02880956
Ethics application status
Date submitted
24/08/2016
Date registered
26/08/2016

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Participants With Early Alzheimer's Disease
Scientific title
A Phase 2 Multiple Dose, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects With Early Alzheimer's Disease
Secondary ID [1] 0 0
2016-001634-10
Secondary ID [2] 0 0
M15-566
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(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - ABBV-8E12
Treatment: Drugs - placebo for ABBV-8E12

Placebo comparator: Placebo - Placebo for ABBV-8E12 every 4 weeks for 96 weeks

Experimental: ABBV-8E12 300 mg - ABBV-8E12 300 mg every 4 weeks for 96 weeks

Experimental: ABBV-8E12 1000 mg - ABBV-8E12 1000 mg every 4 weeks for 96 weeks

Experimental: ABBV-8E12 2000 mg - ABBV-8E12 2000 mg every 4 weeks for 96 weeks


Treatment: Drugs: ABBV-8E12
ABBV-8E12 solution for IV infusion

Treatment: Drugs: placebo for ABBV-8E12
placebo solution for intravenous (IV) infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline Over Time in CDR-SB Score
Timepoint [1] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Primary outcome [2] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
From first dose of study drug up to last dose of study drug plus 20 weeks (up to Week 112)
Secondary outcome [1] 0 0
Maximum Observed Serum Concentration (Cmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
Timepoint [1] 0 0
Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99.
Secondary outcome [2] 0 0
Time to Cmax (Tmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
Timepoint [2] 0 0
Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99.
Secondary outcome [3] 0 0
Serum Concentration at the End of a Dose Interval (Ctrough) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
Timepoint [3] 0 0
Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99.
Secondary outcome [4] 0 0
Half-Life (T1/2) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
Timepoint [4] 0 0
Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99.
Secondary outcome [5] 0 0
Area Under the Concentration-Time Curve From Dosing (Time 0) to Day 28 (AUC0-28) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
Timepoint [5] 0 0
Day 1 (Dose 1): pre-infusion, up to Day 29 (trough level before Dose 2). Day 85 (Dose 4): pre-infusion, up to Day 113 (trough level before Dose 5). See Outcome Measure description above for complete time point details.
Secondary outcome [6] 0 0
Cmax/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
Timepoint [6] 0 0
Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99.
Secondary outcome [7] 0 0
AUC0-28/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
Timepoint [7] 0 0
Day 1 (Dose 1): pre-infusion, up to Day 29 (trough level before Dose 2). Day 85 (Dose 4): pre-infusion, up to Day 113 (trough level before Dose 5). See Outcome Measure description above for complete time point details.
Secondary outcome [8] 0 0
Change From Baseline Over Time in Alzheimer's Disease Assessment Scale (14-Item) Cognition Portion (ADAS-Cog-14) Total Score
Timepoint [8] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [9] 0 0
Change From Baseline Over Time in ADAS-Cog-14 Comprehension of Spoken Language Score
Timepoint [9] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [10] 0 0
Change From Baseline Over Time in ADAS-Cog-14 Constructional Praxis Score
Timepoint [10] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [11] 0 0
Change From Baseline Over Time in ADAS-Cog-14 Commands Score
Timepoint [11] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [12] 0 0
Change From Baseline Over Time in ADAS-Cog-14 Delayed Word Recall Score
Timepoint [12] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [13] 0 0
Change From Baseline Over Time in ADAS-Cog-14 Ideational Praxis Score
Timepoint [13] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [14] 0 0
Change From Baseline Over Time in ADAS-Cog-14 Maze Task Score
Timepoint [14] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [15] 0 0
Change From Baseline Over Time in ADAS-Cog-14 Number Cancellation Score
Timepoint [15] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [16] 0 0
Change From Baseline Over Time in ADAS-Cog-14 Naming Score
Timepoint [16] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [17] 0 0
Change From Baseline Over Time in ADAS-Cog-14 Orientation Score
Timepoint [17] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [18] 0 0
Change From Baseline Over Time in ADAS-Cog-14 Word Recall - Number of Words Not Recalled Score
Timepoint [18] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [19] 0 0
Change From Baseline Over Time in ADAS-Cog-14 Remember Word Recognition Instructions Score
Timepoint [19] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [20] 0 0
Change From Baseline Over Time in ADAS-Cog-14 Spoken Language Ability Score
Timepoint [20] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [21] 0 0
Change From Baseline Over Time in ADAS-Cog-14 Word Find Difficulty Spontaneous Speech Score
Timepoint [21] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [22] 0 0
Change From Baseline Over Time in ADAS-Cog-14 Word Recognition Score
Timepoint [22] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [23] 0 0
Change From Baseline Over Time in Functional Activities Questionnaire (FAQ) Score
Timepoint [23] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [24] 0 0
Change From Baseline Over Time in Alzheimer's Disease Cooperative Study Clinical Global Impression of Change for Mild Cognitive Impairment (ADCS-CGIC-MCI) General Condition Score
Timepoint [24] 0 0
Baseline, Week 48, Week 96
Secondary outcome [25] 0 0
Change From Baseline Over Time in ADCS-CGIC-MCI Cognition Score
Timepoint [25] 0 0
Baseline, Week 48, Week 96
Secondary outcome [26] 0 0
Change From Baseline Over Time in ADCS-CGIC-MCI Behavior Score
Timepoint [26] 0 0
Baseline, Week 48, Week 96
Secondary outcome [27] 0 0
Change From Baseline Over Time in ADCS-CGIC-MCI Functional Abilities Score
Timepoint [27] 0 0
Baseline, Week 48, Week 96
Secondary outcome [28] 0 0
Change From Baseline Over Time in University of California's Performance Based Skills Assessment, Brief Version (UPSA-Brief) - Total Score
Timepoint [28] 0 0
Baseline, Week 48, Week 96
Secondary outcome [29] 0 0
Change From Baseline Over Time in 24-Item Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for Patients With Mild Cognitive Impairment (ADCS-MCI-ADL-24) Total Score
Timepoint [29] 0 0
Baseline, Week 48, Week 96
Secondary outcome [30] 0 0
Change From Baseline Over Time in Repeatable Battery for Assessment of Neuropsychological Status (RBANS) - Total Scale Score
Timepoint [30] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [31] 0 0
Change From Baseline Over Time in RBANS - Coding Total Score
Timepoint [31] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [32] 0 0
Change From Baseline Over Time in RBANS - Digit Span Total Score
Timepoint [32] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [33] 0 0
Change From Baseline Over Time in RBANS - Figure Copy Total Score
Timepoint [33] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [34] 0 0
Change From Baseline Over Time in RBANS - Figure Recall Total Score
Timepoint [34] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [35] 0 0
Change From Baseline Over Time in RBANS - List Recognition Total Score
Timepoint [35] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [36] 0 0
Change From Baseline Over Time in RBANS - List Learning Total Score
Timepoint [36] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [37] 0 0
Change From Baseline Over Time in RBANS - Line Orientation Total Score
Timepoint [37] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [38] 0 0
Change From Baseline Over Time in RBANS - List Recall Total Score
Timepoint [38] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [39] 0 0
Change From Baseline Over Time in RBANS - Picture Naming Total Score
Timepoint [39] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [40] 0 0
Change From Baseline Over Time in RBANS - Semantic Fluency Total Score
Timepoint [40] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [41] 0 0
Change From Baseline Over Time in RBANS - Story Memory Total Score
Timepoint [41] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [42] 0 0
Change From Baseline Over Time in RBANS - Story Recall Total Score
Timepoint [42] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [43] 0 0
Change From Baseline Over Time in Mini-Mental State Examination (MMSE) Total Score
Timepoint [43] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [44] 0 0
Change From Baseline Over Time in Neuropsychiatry Inventory (NPI) Total Score
Timepoint [44] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96
Secondary outcome [45] 0 0
Change From Baseline Over Time in Alzheimer's Disease Composite Score (ADCOMS) Score
Timepoint [45] 0 0
Baseline, Week 24, Week 48, Week 72, Week 96

Eligibility
Key inclusion criteria
* Subject who meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) clinical criteria for mild cognitive impairment or probable AD, and have:

* Clinical Dementia Rating (CDR)-Global Score of 0.5
* Mini-Mental State Examination (MMSE) score of 22 to 30, inclusive
* Repeatable Battery for the Assessment of Neuropsychological Status-Delayed Memory Index (RBANS - DMI) score of 85 or lower
* Subject has a positive amyloid positron emission tomography (PET) scan.
* Subject has a Modified Hachinski Ischemic Scale (MHIS) score of = 4.
* The subject has an identified, reliable, study partner (e.g., family member).
* If using medications to treat symptoms related to AD, doses must be stable for at least 12 weeks prior to randomization.
Minimum age
55 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject has any contraindications or inability to tolerate brain magnetic resonance imaging (MRI), PET scans or lumbar puncture.
* Subject has evidence of any other clinically significant neurological disorder other than early AD.
* In the opinion of the investigator, the subject has any clinically significant or uncontrolled medical or psychiatric illness, or has had an infection requiring medical intervention in the past 30 days.
* Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic attack or required intervention for any of these conditions within 6 months of Screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/07/2021
Sample size
Target
Accrual to date
Final
453
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
The Kinghorn Cancer Centre /ID# 152632 - Darlinghurst
Recruitment hospital [2] 0 0
Griffith University /ID# 152635 - Southport
Recruitment hospital [3] 0 0
Austin Health /ID# 152637 - Heidelberg
Recruitment hospital [4] 0 0
The Royal Melbourne Hospital /ID# 202633 - Parkville
Recruitment hospital [5] 0 0
Australian Alzheimer's Res Fou /ID# 152634 - Nedlands
Recruitment hospital [6] 0 0
Neurodegenerative Disorders Research /ID# 152826 - West Perth
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
3050 - Parkville
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
6005 - West Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Rhode Island
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
Belgium
State/province [22] 0 0
Bruxelles-Capitale
Country [23] 0 0
Belgium
State/province [23] 0 0
Vlaams-Brabant
Country [24] 0 0
Belgium
State/province [24] 0 0
Liege
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Denmark
State/province [26] 0 0
Hovedstaden
Country [27] 0 0
Finland
State/province [27] 0 0
Varsinais-Suomi
Country [28] 0 0
Finland
State/province [28] 0 0
Kuopio
Country [29] 0 0
Italy
State/province [29] 0 0
Emilia-Romagna
Country [30] 0 0
Italy
State/province [30] 0 0
Lazio
Country [31] 0 0
Italy
State/province [31] 0 0
Umbria
Country [32] 0 0
Italy
State/province [32] 0 0
Brescia
Country [33] 0 0
Italy
State/province [33] 0 0
Milano
Country [34] 0 0
Italy
State/province [34] 0 0
Milan
Country [35] 0 0
Netherlands
State/province [35] 0 0
Utrecht
Country [36] 0 0
New Zealand
State/province [36] 0 0
Burwood
Country [37] 0 0
Spain
State/province [37] 0 0
Pais Vasco
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Sweden
State/province [40] 0 0
Stockholms Lan
Country [41] 0 0
Sweden
State/province [41] 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 Use Agreement (DUA). 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/NCT02880956