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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02880956
Recruitment Status : Completed
First Posted : August 26, 2016
Last Update Posted : February 7, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
This study seeks to evaluate the efficacy and safety of ABBV-8E12 in subjects with Early Alzheimer's Disease.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: ABBV-8E12 Drug: placebo for ABBV-8E12 Phase 2

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 453 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 17, 2016
Actual Primary Completion Date : March 30, 2021
Actual Study Completion Date : July 5, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 2
Dose 2 ABBV-8E12
 Drug: ABBV-8E12
ABBV-8E12 solution for IV infusion
Other Name: Tilavonemab
Experimental: Group 3
Dose 3 ABBV-8E12
 Drug: ABBV-8E12
ABBV-8E12 solution for IV infusion
Other Name: Tilavonemab
Experimental: Group 1
Dose 1 ABBV-8E12
 Drug: ABBV-8E12
ABBV-8E12 solution for IV infusion
Other Name: Tilavonemab
Placebo Comparator: Group 4
Placebo for ABBV-8E12
 Drug: placebo for ABBV-8E12
placebo solution for IV infusion
Other Name: Tilavonemab


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 112 weeks ]
  2. Clinical Dementia Rating - Sum of Boxes (CDR-SB) [ Time Frame: Week 96 ]
    A scale used to quantify the severity of symptoms of dementia.


Secondary Outcome Measures :
  1. 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).

  2. Serum concentration at the end of a dose interval (Ctrough) for ABBV-8E12 [ Time Frame: 96 weeks ]
  3. Area under the concentration time curve (AUC) for ABBV-8E12 [ Time Frame: 16 weeks ]
  4. Time to Cmax (Tmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
  5. Maximum observed serum concentration (Cmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
  6. Mini-Mental State Examination (MMSE) [ Time Frame: 96 weeks ]
    A 30-point questionnaire that provides a quantitative measure of cognitive mental status in adults.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Neuropsychiatry Inventory (NPI) [ Time Frame: 96 weeks ]
    Assesses the presence of psychopathology in subjects with Alzheimer's disease and other dementias.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880956


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02880956    
Other Study ID Numbers: M15-566
2016-001634-10 ( EudraCT Number )
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: February 7, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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

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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
Keywords provided by AbbVie:
Early Alzheimer's Disease (AD)
Mild Cognitive Impairment (MCI)
Mild Alzheimer's Disease (AD)
Tau
Early dementia
 Tauopathies
AD
Neurodegenerative diseases
Memory loss
Nervous system diseases
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
 Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Tilavonemab
Nootropic Agents