Ensayos clínicos

Inclusion Criteria:

• Subject completed the 52-week treatment period of Study M15-562.
• In the opinion of the Investigator, subject was compliant during participation in Study M15-562.
• Subject has an identified, reliable study partner (e.g., caregiver, family member, social worker, or friend), who has frequent contact with the subject (at least 10 hours per week) and who can accompany the subject to study visits to provide information as to the subject's functional abilities.
• Subject voluntarily signed the Independent Ethics Committee (IEC)/Institutional Review Board (IRB) approved Informed Consent Form, prior to the conduct of any study procedures, or, where applicable (i.e., countries other than Germany*) for a given subject, the subject's legally authorized representative (LAR) signed the IEC/IRB approved Informed Consent form on behalf of the subject, prior to the conduct of any procedures.
  • *For Germany, where the subject's LAR is not permitted to sign the IEC/IRB approved Informed Consent form on behalf of the subject, evaluation by an independent psychiatrist will be sought if the investigator who is evaluating the subject for inclusion in the study doubts the subject's cognitive ability to independently provide informed consent.

Exclusion Criteria:

• Subject weighs less than 44 kg (97 lbs.) at time of study entry.
• Subject has any contraindication or inability to tolerate brain MRI (e.g., a pacemaker or any other implanted device or condition that would preclude proximity to a strong magnetic field).
• Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results. The Investigator must re-evaluate the subject for continuing participation and consider any factors including the interim development of any clinically significant neurological, hematological, autoimmune, endocrine, cardiovascular, neoplastic, renal, hepatic, metabolic, psychiatric, pulmonary, gastrointestinal, or other major disorder.
• More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-562.
• Subject is concurrently enrolled in another interventional clinical study involving a therapeutic agent.
• Subject is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.