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A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects With Early Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT02880956
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

August 24, 2016
August 26, 2016
September 18, 2018
October 17, 2016
December 16, 2020   (Final data collection date for primary outcome measure)
  • Adverse Events [ Time Frame: 112 weeks ]
  • Clinical Dementia Rating - Sum of Boxes (CDR-SB) [ Time Frame: Week 96 ]
    A scale used to quantify the severity of symptoms of dementia.
  • Clinical Dementia Rating - Sum of Boxes (CDR-SB) [ Time Frame: Week 96 ]
    A scale used to quantify the severity of symptoms of dementia.
  • Adverse Events [ Time Frame: 112 weeks ]
Complete list of historical versions of study NCT02880956 on ClinicalTrials.gov Archive Site
  • University of California's Performance Based Skills Assessment, Brief Version (UPSA-Brief) [ Time Frame: 96 weeks ]
    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).
  • Serum concentration at the end of a dose interval (Ctrough) for ABBV-8E12 [ Time Frame: 96 weeks ]
  • Area under the concentration time curve (AUC) for ABBV-8E12 [ Time Frame: 16 weeks ]
  • Time to Cmax (Tmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
  • Maximum observed serum concentration (Cmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
  • Mini-Mental State Examination (MMSE) [ Time Frame: 96 weeks ]
    A 30-point questionnaire that provides a quantitative measure of cognitive mental status in adults.
  • 24-Item Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for Patients with Mild Cognitive Impairment (ADCS-MCI-ADL-24) [ Time Frame: 96 weeks ]
    A 24-item, study partner-based assessment of activities of daily living designed specifically for AD patients.
  • Functional Activities Questionnaire (FAQ) [ Time Frame: 96 weeks ]
    A questionnaire used to measure level of assistance (functional disability) needed for carrying out instrumental activities in daily living.
  • Repeatable Battery for Assessment of Neuropsychological Status (RBANS) [ Time Frame: 96 weeks ]
    A standardized neurocognitive battery that measures cognitive decline or improvement across five neurocognitive domains.
  • Alzheimer's Disease Cooperative Study Clinical Global Impression of Change for Mild Cognitive Impairment (ADCS-CGIC-MCI). [ Time Frame: 96 weeks ]
    The instrument assesses the physician's global impression of change four major cognitive domains.
  • Alzheimer's Disease Assessment Scale (14-Item) Cognition Portion (ADAS-Cog-14) [ Time Frame: 96 weeks ]
    A scale that assesses the cognitive impairments most common in AD.
  • Neuropsychiatry Inventory (NPI) [ Time Frame: 96 weeks ]
    Assesses the presence of psychopathology in subjects with Alzheimer's disease and other dementias.
  • Maximum observed serum concentration (Cmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
  • Time to Cmax (Tmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
  • Area under the concentration time curve (AUC) for ABBV-8E12 [ Time Frame: 16 weeks ]
  • Serum concentration at the end of a dose interval (Ctrough) for ABBV-8E12 [ Time Frame: 96 weeks ]
  • Mini-Mental State Examination (MMSE) [ Time Frame: 96 weeks ]
    A 30-point questionnaire that provides a quantitative measure of cognitive mental status in adults.
  • Alzheimer's Disease Assessment Scale (14-Item) Cognition Portion (ADAS-Cog-14) [ Time Frame: 96 weeks ]
    A scale that assesses the cognitive impairments most common in AD.
  • Repeatable Battery for Assessment of Neuropsychological Status (RBANS) [ Time Frame: 96 weeks ]
    A standardized neurocognitive battery that measures cognitive decline or improvement across five neurocognitive domains.
  • 24-Item Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for Patients with Mild Cognitive Impairment (ADCS-MCI-ADL-24) [ Time Frame: 96 weeks ]
    A 24-item, study partner-based assessment of activities of daily living designed specifically for AD patients.
  • Functional Activities Questionnaire (FAQ) [ Time Frame: 96 weeks ]
    A questionnaire used to measure level of assistance (functional disability) needed for carrying out instrumental activities in daily living.
  • University of California's Performance Based Skills Assessment, Brief Version (UPSA-Brief) [ Time Frame: 96 weeks ]
    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).
  • Alzheimer's Disease Cooperative Study Clinical Global Impression of Change for Mild Cognitive Impairment (ADCS-CGIC-MCI). [ Time Frame: 96 weeks ]
    The instrument assesses the physician's global impression of change four major cognitive domains.
Not Provided
Not Provided
 
A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects With Early Alzheimer's Disease
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
This study seeks to evaluate the efficacy and safety of ABBV-8E12 in subjects with Early Alzheimer's Disease.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: ABBV-8E12
    ABBV-8E12 solution for IV infusion
  • Drug: placebo for ABBV-8E12
    placebo solution for IV infusion
  • Experimental: Group 2
    Dose 2 ABBV-8E12
    Intervention: Drug: ABBV-8E12
  • Experimental: Group 3
    Dose 3 ABBV-8E12
    Intervention: Drug: ABBV-8E12
  • Experimental: Group 1
    Dose 1 ABBV-8E12
    Intervention: Drug: ABBV-8E12
  • Placebo Comparator: Group 4
    Placebo for ABBV-8E12
    Intervention: Drug: placebo for ABBV-8E12
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
Same as current
September 23, 2022
December 16, 2020   (Final data collection date for primary outcome measure)

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.

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.
Sexes Eligible for Study: All
55 Years to 85 Years   (Adult, Older Adult)
No
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
Australia,   Belgium,   Canada,   Denmark,   Finland,   Italy,   Netherlands,   New Zealand,   Spain,   Sweden,   United States
 
 
NCT02880956
M15-566
2016-001634-10 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: 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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
AbbVie
AbbVie
Not Provided
Study Director: AbbVie Inc. AbbVie
AbbVie
September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP