An Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD)

• Status: Active, not recruiting
• Trial end date: 2021-07-05
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Tilavonemab

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)