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

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

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

Study Overview

• Status: Terminated
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: Tilavonemab

• Study Type: Interventional
• Enrollment (Actual): 364
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • St Vincent's Centre for Applied Medical Research /ID# 204903
  • Queensland
    • Southport, Queensland, Australia, 4222
      • Griffith University /ID# 204905
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health /ID# 204906
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Australian Alzheimer's Res Fou /ID# 204904
• Belgium
  • Liege, Belgium, 4000
    • Groupe Sante CHC - Clinique du MontLegia /ID# 204964
  • Bruxelles-Capitale
    • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
      • UCL Saint-Luc /ID# 204963
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Universitair Ziekenhuis Leuven /ID# 204965
• Canada
  • Ontario
    • London, Ontario, Canada, N6C 0A7
      • Parkwood Institute /ID# 204121
    • Toronto, Ontario, Canada, M3B 2S7
      • Toronto Memory Program /ID# 204120
• Denmark
  • Hovedstaden
    • Copenhagen Ø, Hovedstaden, Denmark, 2100
      • Rigshospitalet /ID# 204591
• Finland
  • Kuopio, Finland, 70210
    • Ita-Suomen Yliopisto /ID# 204538
  • Varsinais-Suomi
    • Turku, Varsinais-Suomi, Finland, 20520
      • Clinical Research Services Turku /ID# 205924
• Italy
  • Brescia, Italy, 25125
    • IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli /ID# 203903
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 203902
  • Milano, Italy, 20162
    • ASST Grande Ospedale Metropolitano Niguarda /ID# 203901
  • Emilia-Romagna
    • Modena, Emilia-Romagna, Italy, 41126
      • AOU di Modena /ID# 203904
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Policlinico Agostino Gemelli /ID# 203906
  • Umbria
    • Perugia, Umbria, Italy, 06129
      • Azienda Ospedaliera di Perugia /ID# 203905
• New Zealand
  • Burwood, New Zealand, 8083
    • CGM Research Trust /ID# 204907
• Spain
  • Barcelona, Spain, 08028
    • Fundacio ACE /ID# 204520
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona /ID# 204519
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre /ID# 204518
  • Pais Vasco
    • Donostia, Pais Vasco, Spain, 20009
      • Fundacion CITA Alzheimer Fundazioa /ID# 204521
• Sweden
  • Stockholms Lan
    • Stockholm, Stockholms Lan, Sweden, 171 77
      • Karolinska University Hospital Huddinge /ID# 203900
  • Vastra Gotalands Lan
    • Molndal, Vastra Gotalands Lan, Sweden, 431 80
      • Sahlgrenska University Hospital Molndal /ID# 203899
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner University of Arizona Medical Center Phoenix /ID# 203959
  • California
    • Irvine, California, United States, 92614
      • Irvine Clinical Research /ID# 204000
    • La Jolla, California, United States, 92037
      • Ucsd /Id# 204001
    • San Francisco, California, United States, 94143-0633
      • University of California, San /ID# 204011
  • Florida
    • Delray Beach, Florida, United States, 33445
      • Brain Matters Research /ID# 203957
    • Fort Myers, Florida, United States, 33912
      • Neuropsychiatric Research Center of Southwest Florida /ID# 203956
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic /ID# 203995
    • Orlando, Florida, United States, 32806-1044
      • Synexus Clinical Research US, Inc. /ID# 203992
    • Tampa, Florida, United States, 33612
      • University of South Florida /ID# 204009
    • The Villages, Florida, United States, 32162-7116
      • Synexus Clinical Research US, Inc /ID# 204010
  • Georgia
    • Atlanta, Georgia, United States, 30329-2206
      • Emory University / Emory Brain Health Center /ID# 203999
    • Decatur, Georgia, United States, 30030
      • NeuroStudies.net, LLC /ID# 204004
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Advocate Lutheran General Hospital /ID# 203993
    • Springfield, Illinois, United States, 62702
      • Southern IL Univ School of Med /ID# 203952
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University /ID# 203989
  • Kansas
    • Fairway, Kansas, United States, 66205
      • University of Kansas Medical Center - Alzheimer's Disease Center /ID# 203960
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Chandler Medical Center /ID# 203996
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital /ID# 203954
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Physicians /ID# 204003
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic /ID# 213435
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Princeton Medical Institute /ID# 203953
  • New York
    • New Hyde Park, New York, United States, 11040
      • North Shore University Hospital /ID# 203994
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Univ Med Ctr /ID# 203958
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University /ID# 203997
  • Pennsylvania
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • Keystone Clinical Studies LLC /ID# 213183
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital /ID# 204005
  • Tennessee
    • Nashville, Tennessee, United States, 37232-0021
      • Vanderbilt Ingram Cancer Center /ID# 203951
  • Texas
    • Dallas, Texas, United States, 75231-4316
      • Kerwin Research Center /ID# 203998
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital /ID# 204002
    • Houston, Texas, United States, 77054
      • McGovern Medical School /ID# 213312
  • Utah
    • Salt Lake City, Utah, United States, 84112-5500
      • University of Utah /ID# 203991
  • Virginia
    • Alexandria, Virginia, United States, 22310
      • Integrated Neurology Services /ID# 203990

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 300 mg/1000 mg 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.	Drug: Tilavonemab; solution for IV infusion; Other Names: ABBV-8E12
Experimental: 1000 mg/1000 mg 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.	Drug: Tilavonemab; solution for IV infusion; Other Names: ABBV-8E12
Experimental: 2000 mg/2000 mg 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.	Drug: Tilavonemab; solution for IV infusion; Other Names: ABBV-8E12
Experimental: PBO/2000 mg 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.	Drug: Tilavonemab; solution for IV infusion; Other Names: ABBV-8E12

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Study Drug, and Fatal TEAEs	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.	From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values	Clinical laboratory PCS criteria were adapted from National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values	Clinical laboratory PCS criteria were adapted from NCI CTCAE version 4.03	Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Columbia-Suicide Severity Rating Scale (C-SSRS) During Double-Blind Treatment Period	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.	Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
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.

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2019
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: October 18, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (Actual): October 19, 2018

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Nootropic Agents; Tilavonemab
• Other Study ID Numbers: M15-570; 2018-000268-26 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.
• IPD Sharing Time Frame: For details on when studies are available for sharing, please refer to the link below.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• 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