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Summary

for people ages 55–85 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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

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

Keywords

Alzheimer's Disease 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

Eligibility

You can join if…

Open to people ages 55–85

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Ray Dolby Brain Health Center/CPMC /ID# 154965 not yet accepting patients
    San Francisco, California, 94114, United States
  • Neurological Research Institute /ID# 152718 not yet accepting patients
    Santa Monica, California, 90404, United States
  • Irvine Clinical Research /ID# 162331 not yet accepting patients
    Irvine, California, 92614, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT02880956
Phase
Phase 2
Lead Scientist
Richard Tsai
Study Type
Interventional
Last Updated
May 1, 2017
I’m interested in this study!