Summary

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

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 DiseaseEarly Alzheimer's Disease (AD)Mild Cognitive Impairment (MCI)Mild Alzheimer's Disease (AD)TauEarly dementiaTauopathiesADNeurodegenerative diseasesMemory lossNervous system diseasesAlzheimer DiseaseABBV-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

  • Univ California, San Francisco /ID# 152053accepting new patients
    San FranciscoCalifornia94143-2204United States
  • Ray Dolby Brain Health Center /ID# 154965completed
    San FranciscoCalifornia94113United States

Lead Scientist

  • Richard Tsai
    Authored (or co-authored) 12 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT02880956
Phase
Phase 2
Study Type
Interventional
Last Updated