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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02880956
Ethics application status
Date submitted
24/08/2016
Date registered
26/08/2016
Date last updated
6/05/2021

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects 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

Experimental: Group 2 - Dose 2 ABBV-8E12

Experimental: Group 3 - Dose 3 ABBV-8E12

Experimental: Group 1 - Dose 1 ABBV-8E12

Placebo Comparator: Group 4 - Placebo for ABBV-8E12


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

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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Events
Timepoint [1] 0 0
112 weeks
Primary outcome [2] 0 0
Clinical Dementia Rating - Sum of Boxes (CDR-SB) - A scale used to quantify the severity of symptoms of dementia.
Timepoint [2] 0 0
Week 96
Secondary outcome [1] 0 0
University of California's Performance Based Skills Assessment, Brief Version (UPSA-Brief) - A performance-based instrument which uses a series of tasks and role-play scenarios to evaluate a person's functional capacity in two areas of basic living skills (i.e., financial skills and communication skills).
Timepoint [1] 0 0
96 weeks
Secondary outcome [2] 0 0
Serum concentration at the end of a dose interval (Ctrough) for ABBV-8E12
Timepoint [2] 0 0
96 weeks
Secondary outcome [3] 0 0
Area under the concentration time curve (AUC) for ABBV-8E12
Timepoint [3] 0 0
16 weeks
Secondary outcome [4] 0 0
Time to Cmax (Tmax) for ABBV-8E12
Timepoint [4] 0 0
16 weeks
Secondary outcome [5] 0 0
Maximum observed serum concentration (Cmax) for ABBV-8E12
Timepoint [5] 0 0
16 weeks
Secondary outcome [6] 0 0
Mini-Mental State Examination (MMSE) - A 30-point questionnaire that provides a quantitative measure of cognitive mental status in adults.
Timepoint [6] 0 0
96 weeks
Secondary outcome [7] 0 0
24-Item Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for Patients with Mild Cognitive Impairment (ADCS-MCI-ADL-24) - A 24-item, study partner-based assessment of activities of daily living designed specifically for AD patients.
Timepoint [7] 0 0
96 weeks
Secondary outcome [8] 0 0
Functional Activities Questionnaire (FAQ) - A questionnaire used to measure level of assistance (functional disability) needed for carrying out instrumental activities in daily living.
Timepoint [8] 0 0
96 weeks
Secondary outcome [9] 0 0
Repeatable Battery for Assessment of Neuropsychological Status (RBANS) - A standardized neurocognitive battery that measures cognitive decline or improvement across five neurocognitive domains.
Timepoint [9] 0 0
96 weeks
Secondary outcome [10] 0 0
Alzheimer's Disease Cooperative Study Clinical Global Impression of Change for Mild Cognitive Impairment (ADCS-CGIC-MCI). - The instrument assesses the physician's global impression of change four major cognitive domains.
Timepoint [10] 0 0
96 weeks
Secondary outcome [11] 0 0
Alzheimer's Disease Assessment Scale (14-Item) Cognition Portion (ADAS-Cog-14) - A scale that assesses the cognitive impairments most common in AD.
Timepoint [11] 0 0
96 weeks
Secondary outcome [12] 0 0
Neuropsychiatry Inventory (NPI) - Assesses the presence of psychopathology in subjects with Alzheimer's disease and other dementias.
Timepoint [12] 0 0
96 weeks

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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
St. Vincent's Hospital, Darlinghurst /ID# 152632 - Darlinghurst
Recruitment hospital [2] 0 0
Griffith University /ID# 152635 - Southport
Recruitment hospital [3] 0 0
Austin Hospital /ID# 152637 - Heidelberg
Recruitment hospital [4] 0 0
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 Re /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
Leuven
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
Lombardia
Country [32] 0 0
Italy
State/province [32] 0 0
Brescia
Country [33] 0 0
Italy
State/province [33] 0 0
Perugia
Country [34] 0 0
Netherlands
State/province [34] 0 0
Utrecht
Country [35] 0 0
New Zealand
State/province [35] 0 0
Burwood Christchurch
Country [36] 0 0
Spain
State/province [36] 0 0
Pais Vasco
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona
Country [38] 0 0
Spain
State/province [38] 0 0
Madrid
Country [39] 0 0
Sweden
State/province [39] 0 0
Vastra Gotalands Lan
Country [40] 0 0
Sweden
State/province [40] 0 0
Huddinge

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

Ethics approval
Ethics application status

Summary
Brief summary
This study seeks to evaluate the efficacy and safety of ABBV-8E12 in subjects with Early
Alzheimer's Disease.
Trial website
https://clinicaltrials.gov/show/NCT02880956
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

Summary results
Other publications