Summary

for people ages 55-85 (full criteria)
at UCSFUCSD
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 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 Alzheimer Disease ABBV-8E12

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 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

  • Ucsd /Id# 152467
    La Jolla California 92037 United States
  • Univ California, San Francisco /ID# 152053
    San Francisco California 94143-2204 United States
  • Irvine Clinical Research /ID# 162331
    Irvine California 92614 United States
  • Ray Dolby Brain Health Center /ID# 154965
    San Francisco California 94113 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT02880956
Phase
Phase 2
Study Type
Interventional
Last Updated