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Trial record 1 of 1 for:    m15-566
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A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects With Early Alzheimer's Disease

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02880956
First received: August 24, 2016
Last updated: May 8, 2017
Last verified: May 2017
  Purpose
This study seeks to evaluate the efficacy and safety of ABBV-8E12 in subjects with Early Alzheimer's Disease.

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 400
Study Start Date: October 17, 2016
Estimated Study Completion Date: June 3, 2021
Estimated Primary Completion Date: December 16, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Dose 1 ABBV-8E12
Drug: ABBV-8E12
ABBV-8E12 (20 mg/mL) solution for IV infusion
Experimental: Group 2
Dose 2 ABBV-8E12
Drug: ABBV-8E12
ABBV-8E12 (20 mg/mL) solution for IV infusion
Experimental: Group 3
Dose 3 ABBV-8E12
Drug: ABBV-8E12
ABBV-8E12 (20 mg/mL) solution for IV infusion
Placebo Comparator: Group 4
Placebo for ABBV-8E12
Drug: placebo for ABBV-8E12
placebo solution for IV infusion

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
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 to 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02880956

Contacts
Contact: AbbVie_Call Center 847-283-8955 abbvieclinicaltrials@abbvie.com

  Show 47 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Hana Florian, MD AbbVie
  More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02880956     History of Changes
Other Study ID Numbers: M15-566
2016-001634-10 ( EudraCT Number )
Study First Received: August 24, 2016
Last Updated: May 8, 2017

Keywords provided by AbbVie:
Tau
Nervous system diseases
Memory loss
Mild Alzheimer's Disease (AD)
Early Alzheimer's Disease
Early dementia
Mild Cognitive Impairment (MCI)
AD
Tauopathies
Neurodegenerative diseases

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2017