A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy
The purpose of this study is to assess efficacy, safety, tolerability, and pharmacokinetics of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).
40 Years and up
Accepting Healthy Volunteers?
- 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).
- 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.
- Progressive Supranuclear Palsy (PSP)