ABBV-8E12 in Progressive Supranuclear Palsy

Condition: Progressive supranuclear palsy

Eligibility

Key Inclusion Criteria

  • At least 40 years old
  • Meets criteria for possible or probable progressive supranuclear palsy
  • Presence of PSP symptoms for less than five years
  • Able to walk five steps with minimal assistance

Key Exclusion Criteria

  • Weighs less than 44 kg (97 lbs) at screening
  • Mini-Mental State Examination score less than 15 at screening
  • Contraindication or inability to tolerate brain MRI
  • Residing at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period

Full Study Name

A Phase II, Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy (IRB no. 47591)

Summary

This study focuses on patients with progressive supranuclear palsy (PSP) who are over 40 years old. The purpose of the study is to evaluate an investigational drug called ABBV-8E12 and learn whether it could help slow down a disease called progressive supranuclear palsy (PSP). The study will also assess various doses of the drug and confirm its safety in patients with PSP.

Researchers aim to determine the effects that treatment with ABBV-8E12 will have on blood chemistry, cerebrospinal fluid, and clinical and biological markers of PSP. Information from brain magnetic resonance imaging (MRI) scans will also be collected to evaluate whether ABBV-8E12 appears to have an effect on the PSP disease process. Participants will be monitored carefully for side effects.

Phase

Phase II


Principal Investigator

Michele Tagliati, MD

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