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

AbbVie

Status and phase: Terminated; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: Tilavonemab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03712787

2018-000268-26 (EudraCT Number)

M15-570

Details and patient eligibility

About

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

Enrollment: 364 patients

Sex: All

Ages: 57 to 88 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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364 participants in 4 patient groups

300 mg/1000 mg Tilavonemab

Experimental group

Description:

Participants who received 300 mg tilavonemab in Study M15-566 receive 1000 mg tilavonemab in Study M15-570 via intravenous (IV) infusion every 4 weeks for up to 5.5 years.

Treatment:

Drug: Tilavonemab

1000 mg/1000 mg Tilavonemab

Experimental group

Description:

Participants who received 1000 mg tilavonemab in Study M15-566 continue on the same dose in Study M15-570 via IV infusion every 4 weeks for up to 5.5 years.

Treatment:

Drug: Tilavonemab

2000 mg/2000 mg Tilavonemab

Experimental group

Description:

Participants who received 2000 mg tilavonemab in Study M15-566 continue on the same dose in Study M15-570 via IV infusion every 4 weeks for up to 5.5 years.

Treatment:

Drug: Tilavonemab

PBO/2000 mg Tilavonemab

Experimental group

Description:

Participants who received placebo (PBO) in Study M15-566 receive 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks for up to 5.5 years.

Treatment:

Drug: Tilavonemab