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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 30, 2021

Interventions

  • Drug: ABBV-8E12
    • ABBV-8E12 solution for IV infusion
  • Drug: placebo for ABBV-8E12
    • placebo solution for IV infusion

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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.
  • Gender Eligibility: All

    Minimum Age: 55 Years

    Maximum Age: 85 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • AbbVie
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • AbbVie Inc., Study Director, AbbVie

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