A Study to Assess the Effectiveness, Safety, Tolerability, and Drug/Body Interactions of ABBV-8E12 in Progressive Supranuclear Palsy

Overview

About this study

The purpose of this study is to assess the effectiveness, safety, tolerability, and drug/body interactions of ABBV-8E12 for the treatment of patients who have progressive supranuclear palsy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

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

Exclusion Criteria

Weighs 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)
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
A history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-V or ICD-10 criteria
Has had a significant illness or infection requiring medical intervention in the past 30 days

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Jacksonville, Fla. Mayo Clinic principal investigator Zbigniew Wszolek, M.D.	Closed for enrollment
Rochester, Minn. Mayo Clinic principal investigator James Bower, M.D.	Closed for enrollment
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Erika Driver-Dunckley, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Zbigniew Wszolek, M.D.

Closed for enrollment

Rochester, Minn.

Mayo Clinic principal investigator

James Bower, M.D.

Closed for enrollment

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Erika Driver-Dunckley, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

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