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

Study Identifier
M15-570
CT.gov Identifier
NCT03712787
EudraCT Identifier
2018-000268-26
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Other
Sign up for trial alerts

Results Available

Protocol
Available Language(s): English
Download document(s)
Statistical Analysis Plan
Available Language(s): English
Download document(s)
Plain Language Summary
Available Language(s): English, Dutch (Belgium), Finnish, Italian, Spanish, Swedish
Download document(s)

Study Details

Medical Condition
  • Alzheimer's Disease
    • Study Drug
  • Tilavonemab
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    57 - 88 Years
    Inclusion and Exclusion 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)

    Protocol Summary

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

    Study Locations

    Location
    Status
    Location
    Banner University of Arizona Medical Center Phoenix /ID# 203959
    Phoenix, Arizona, United States, 85006
    Status
    Not applicable
    Location
    Irvine Clinical Research /ID# 204000
    Irvine, California, United States, 92614
    Status
    Not applicable
    Location
    Ucsd /Id# 204001
    La Jolla, California, United States, 92037
    Status
    Not applicable
    Location
    University of California, San /ID# 204011
    San Francisco, California, United States, 94143-0633
    Status
    Not applicable
    Location
    Brain Matters Research /ID# 203957
    Delray Beach, Florida, United States, 33445
    Status
    Not applicable
    Location
    Neuropsychiatric Research Center of Southwest Florida /ID# 203956
    Fort Myers, Florida, United States, 33912
    Status
    Not applicable
    Showing {first} - {last} of {total} Results