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

Phase 2

Terminated

• Conditions: Alzheimer's Disease
• Interventions: Drug: Tilavonemab

• Registration Number: NCT03712787
• Lead Sponsor: AbbVie

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-18
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-19
• Study Start: 2019-03-22
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2022-08
• Results First Submitted: 2022-08-25
• Results First Submitted QC: 2022-08-25
• Last Update Submitted: 2022-08-25
• Results First Posted: 2022-09-22
• Last Update Posted: 2022-09-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 364

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
300 mg/1000 mg Tilavonemab	Tilavonemab	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.
1000 mg/1000 mg Tilavonemab	Tilavonemab	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.
2000 mg/2000 mg Tilavonemab	Tilavonemab	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.
PBO/2000 mg Tilavonemab	Tilavonemab	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.

Primary Outcome Measures

Name	Time	Method
Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values	Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	Clinical laboratory PCS criteria were adapted from National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values	Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	Clinical laboratory PCS criteria were adapted from NCI CTCAE version 4.03
Brain Magnetic Resonance Imaging (MRI) Results: Number of Participants With Cerebral Edemas, New Microhemorrhage(s), and Severe White Matter Disease	Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Study Drug, and Fatal TEAEs	From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	Treatment emergent adverse events (TEAEs) are defined as any adverse event (AE) from the time of study drug administration until 20 weeks after discontinuation of study drug. An AE is defined as any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious AE (SAE) is defined as any event that: results in death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent serious outcome. Severity of AEs was categorized as mild, moderate, or severe. Relationship of the AE to the study treatment was categorized as having a reasonable possibility or no reasonable possibility.
Columbia-Suicide Severity Rating Scale (C-SSRS) During Double-Blind Treatment Period	Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.	The C-SSRS is a systematically administered instrument developed to track suicidal adverse events across a treatment study. The instrument is designed to assess suicidal behavior and ideation, track and assess all suicidal events, as well as the lethality of attempts. Suicidal ideation categories include the following: wish to be dead; nonspecific active suicidal thoughts; active suicidal ideation without intent to act; active suicidal ideation with some intent to act but no plan; active suicidal ideation with plan and intent. Suicidal behavior categories include the following: actual attempt; interrupted attempt; aborted attempt; preparatory acts or behavior; suicidal behavior; completed suicide.

Trial Locations

Locations (57)

Banner University of Arizona Medical Center Phoenix /ID# 203959; 🇺🇸 Phoenix, Arizona, United States

Irvine Clinical Research /ID# 204000; 🇺🇸 Irvine, California, United States

Ucsd /Id# 204001; 🇺🇸 La Jolla, California, United States

University of California, San /ID# 204011; 🇺🇸 San Francisco, California, United States

Brain Matters Research /ID# 203957; 🇺🇸 Delray Beach, Florida, United States

Neuropsychiatric Research Center of Southwest Florida /ID# 203956; 🇺🇸 Fort Myers, Florida, United States

Mayo Clinic /ID# 203995; 🇺🇸 Jacksonville, Florida, United States

Synexus Clinical Research US, Inc. /ID# 203992; 🇺🇸 Orlando, Florida, United States

University of South Florida /ID# 204009; 🇺🇸 Tampa, Florida, United States

Synexus Clinical Research US, Inc /ID# 204010; 🇺🇸 The Villages, Florida, United States

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