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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03712787
Recruitment Status : Enrolling by invitation
First Posted : October 19, 2018
Last Update Posted : January 31, 2020
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: ABBV-8E12 Phase 2

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Extension Study of ABBV-8E12 in Early Alzheimer's Disease
Actual Study Start Date : March 22, 2019
Estimated Primary Completion Date : August 11, 2026
Estimated Study Completion Date : August 11, 2026

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ABBV-8E12 Dose 1
Participants will receive ABBV-8E12 Dose 1.
Drug: ABBV-8E12
ABBV-8E12 solution for IV infusion
Other Name: Tilavonemab

Experimental: ABBV-8E12 Dose 2
Participants will receive ABBV-8E12 Dose 2.
Drug: ABBV-8E12
ABBV-8E12 solution for IV infusion
Other Name: Tilavonemab

Primary Outcome Measures :
  1. Adverse Events [ Time Frame: From first dose of study drug to 20 weeks after last dose of study drug (up to approximately 5.5 years) ]
    Treatment emergent adverse events defined as any adverse event from the time of study drug administration until 20 weeks after discontinuation of study drug.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   57 Years to 87 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03712787

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Sponsors and Collaborators
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Study Director: AbbVie Inc. AbbVie
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Responsible Party: AbbVie Identifier: NCT03712787    
Other Study ID Numbers: M15-570
2018-000268-26 ( EudraCT Number )
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Nootropic Agents