An Extension Study of ABBV-8E12 in Early Alzheimer’s Disease

Sponsor:

Brief Summary:

The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in
subjects with early AD.

Criteria

Inclusion Criteria:

– All subjects with early AD who complete Study M15-566 (NCT02880956), meet all
inclusion criteria, and do not meet any exclusion criteria are eligible for enrollment

– Subject was compliant during participation in Study M15-566 (NCT02880956)

– Subject has an identified, reliable study partner who has frequent contact with the
subject and who will provide information as to the subject’s cognitive and functional
abilities

Exclusion Criteria:

– The subject has any significant change in his/her medical condition since
participation in Study M15-566 (NCT02880956) that could interfere with the subject’s
participation in Study M15-570, could place the subject at increased risk, or could
confound interpretation of study results

– More than 8 weeks have elapsed since the subject received his/her last dose of study
drug in Study M15-566 (NCT02880956)

– The subject is concurrently enrolled in another interventional clinical study
involving a therapeutic agent with the exception of Study M15-566 (NCT02880956)

Locations

Irvine Clinical Research /ID# 204000, Irvine, California, United States, 92614
University of California, San /ID# 204011, San Francisco, California, United States, 94143-0633