Summary

for people ages 40 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Richard Tsai

Description

Summary

The purpose of this study is to assess efficacy, safety, tolerability, and pharmacokinetics of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).

Official Title

A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy

Keywords

Progressive Supranuclear Palsy (PSP) PSP Steele-Richardson-Olszewski syndrome tauopathy Supranuclear Palsy, Progressive ABBV-8E12

Eligibility

You can join if…

Open to people ages 40 years and up

  • Male or female subject with age 40 years or greater at the time of signed consent.
  • Meets the criteria for possible or probable progressive supranuclear palsy(Steele-Richardson-Olszewski Syndrome).
  • Presence of PSP symptoms for less than 5 years.
  • Subject is able to walk 5 steps with minimal assistance (stabilization of one arm or use of cane/walker).
  • Subject has an identified, reliable, study partner (e.g., caregiver, family member,social worker, or friend).

You CAN'T join if...

  • Subjects who weigh less than 44 kg (97 lbs) at screening.
  • MMSE score less than 15 at screening.
  • Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI).
  • Subject resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period.
  • Evidence of any clinically significant neurological disorder other than PSP.
  • The subject has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-V or ICD-10 criteria.
  • Subject has had a significant illness or infection requiring medical intervention in the past 30 days.

Locations

  • Univ California, San Francisco /ID# 144897
    San Francisco California 94143-2204 United States
  • University of California, Los Angeles /ID# 144896
    Los Angeles California 90095 United States

Lead Scientist

  • Richard Tsai
    Authored (or co-authored) 11 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT02985879
Phase
Phase 2
Study Type
Interventional
Last Updated