Back to resultsAn Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD)
Primary Purpose
Alzheimer's Disease
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tilavonemab
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility 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)
Sites / Locations
- Banner University of Arizona Medical Center Phoenix /ID# 203959
- Irvine Clinical Research /ID# 204000
- Ucsd /Id# 204001
- University of California, San /ID# 204011
- Brain Matters Research /ID# 203957
- Neuropsychiatric Research Center of Southwest Florida /ID# 203956
- Mayo Clinic /ID# 203995
- Synexus Clinical Research US, Inc. /ID# 203992
- University of South Florida /ID# 204009
- Synexus Clinical Research US, Inc /ID# 204010
- Emory University / Emory Brain Health Center /ID# 203999
- NeuroStudies.net, LLC /ID# 204004
- Advocate Lutheran General Hospital /ID# 203993
- Southern IL Univ School of Med /ID# 203952
- Indiana University /ID# 203989
- University of Kansas Medical Center - Alzheimer's Disease Center /ID# 203960
- University of Kentucky Chandler Medical Center /ID# 203996
- Massachusetts General Hospital /ID# 203954
- Brigham and Women's Physicians /ID# 204003
- Hattiesburg Clinic /ID# 213435
- Princeton Medical Institute /ID# 203953
- North Shore University Hospital /ID# 203994
- Duke Univ Med Ctr /ID# 203958
- Oregon Health and Science University /ID# 203997
- Keystone Clinical Studies LLC /ID# 213183
- Rhode Island Hospital /ID# 204005
- Vanderbilt Ingram Cancer Center /ID# 203951
- Kerwin Research Center /ID# 203998
- Houston Methodist Hospital /ID# 204002
- McGovern Medical School /ID# 213312
- University of Utah /ID# 203991
- Integrated Neurology Services /ID# 203990
- St Vincent's Centre for Applied Medical Research /ID# 204903
- Griffith University /ID# 204905
- Austin Health /ID# 204906
- Australian Alzheimer's Res Fou /ID# 204904
- UCL Saint-Luc /ID# 204963
- Universitair Ziekenhuis Leuven /ID# 204965
- Groupe Sante CHC - Clinique du MontLegia /ID# 204964
- Parkwood Institute /ID# 204121
- Toronto Memory Program /ID# 204120
- Rigshospitalet /ID# 204591
- Clinical Research Services Turku /ID# 205924
- Ita-Suomen Yliopisto /ID# 204538
- AOU di Modena /ID# 203904
- Policlinico Agostino Gemelli /ID# 203906
- Azienda Ospedaliera di Perugia /ID# 203905
- IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli /ID# 203903
- ASST Grande Ospedale Metropolitano Niguarda /ID# 203901
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 203902
- CGM Research Trust /ID# 204907
- Fundacion CITA Alzheimer Fundazioa /ID# 204521
- Fundacio ACE /ID# 204520
- Hospital Clinic de Barcelona /ID# 204519
- Hospital Universitario 12 de Octubre /ID# 204518
- Karolinska University Hospital Huddinge /ID# 203900
- Sahlgrenska University Hospital Molndal /ID# 203899
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
300 mg/1000 mg Tilavonemab
1000 mg/1000 mg Tilavonemab
2000 mg/2000 mg Tilavonemab
PBO/2000 mg Tilavonemab
Arm 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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values
Clinical laboratory PCS criteria were adapted from NCI CTCAE version 4.03
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.
Brain Magnetic Resonance Imaging (MRI) Results: Number of Participants With Cerebral Edemas, New Microhemorrhage(s), and Severe White Matter Disease
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03712787
Brief Title
An Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD)
Official Title
An Extension Study of ABBV-8E12 in Early Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Discontinued because of lack of efficacy in the parent study (Study M15-566; NCT02880956).
Study Start Date
March 22, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in participants with early AD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
364 (Actual)
8. Arms, Groups, and Interventions
Arm Title
300 mg/1000 mg Tilavonemab
Arm Type
Experimental
Arm 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.
Arm Title
1000 mg/1000 mg Tilavonemab
Arm Type
Experimental
Arm 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.
Arm Title
2000 mg/2000 mg Tilavonemab
Arm Type
Experimental
Arm 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.
Arm Title
PBO/2000 mg Tilavonemab
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Tilavonemab
Other Intervention Name(s)
ABBV-8E12
Intervention Description
solution for IV infusion
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Study Drug, and Fatal TEAEs
Description
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.
Time Frame
From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Title
Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values
Description
Clinical laboratory PCS criteria were adapted from National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Time Frame
Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Title
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values
Description
Clinical laboratory PCS criteria were adapted from NCI CTCAE version 4.03
Time Frame
Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Title
Columbia-Suicide Severity Rating Scale (C-SSRS) During Double-Blind Treatment Period
Description
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.
Time Frame
Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Title
Brain Magnetic Resonance Imaging (MRI) Results: Number of Participants With Cerebral Edemas, New Microhemorrhage(s), and Severe White Matter Disease
Time Frame
Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
57 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Banner University of Arizona Medical Center Phoenix /ID# 203959
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Irvine Clinical Research /ID# 204000
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Facility Name
Ucsd /Id# 204001
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of California, San /ID# 204011
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0633
Country
United States
Facility Name
Brain Matters Research /ID# 203957
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Neuropsychiatric Research Center of Southwest Florida /ID# 203956
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Mayo Clinic /ID# 203995
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Synexus Clinical Research US, Inc. /ID# 203992
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806-1044
Country
United States
Facility Name
University of South Florida /ID# 204009
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Synexus Clinical Research US, Inc /ID# 204010
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162-7116
Country
United States
Facility Name
Emory University / Emory Brain Health Center /ID# 203999
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329-2206
Country
United States
Facility Name
NeuroStudies.net, LLC /ID# 204004
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Advocate Lutheran General Hospital /ID# 203993
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Southern IL Univ School of Med /ID# 203952
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Indiana University /ID# 203989
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Medical Center - Alzheimer's Disease Center /ID# 203960
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
University of Kentucky Chandler Medical Center /ID# 203996
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Massachusetts General Hospital /ID# 203954
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Physicians /ID# 204003
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Hattiesburg Clinic /ID# 213435
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Princeton Medical Institute /ID# 203953
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
North Shore University Hospital /ID# 203994
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Duke Univ Med Ctr /ID# 203958
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Oregon Health and Science University /ID# 203997
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Keystone Clinical Studies LLC /ID# 213183
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Facility Name
Rhode Island Hospital /ID# 204005
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Vanderbilt Ingram Cancer Center /ID# 203951
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0021
Country
United States
Facility Name
Kerwin Research Center /ID# 203998
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231-4316
Country
United States
Facility Name
Houston Methodist Hospital /ID# 204002
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
McGovern Medical School /ID# 213312
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
University of Utah /ID# 203991
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5500
Country
United States
Facility Name
Integrated Neurology Services /ID# 203990
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22310
Country
United States
Facility Name
St Vincent's Centre for Applied Medical Research /ID# 204903
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Griffith University /ID# 204905
City
Southport
State/Province
Queensland
ZIP/Postal Code
4222
Country
Australia
Facility Name
Austin Health /ID# 204906
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Australian Alzheimer's Res Fou /ID# 204904
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
UCL Saint-Luc /ID# 204963
City
Woluwe-Saint-Lambert
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven /ID# 204965
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Groupe Sante CHC - Clinique du MontLegia /ID# 204964
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Parkwood Institute /ID# 204121
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 0A7
Country
Canada
Facility Name
Toronto Memory Program /ID# 204120
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 2S7
Country
Canada
Facility Name
Rigshospitalet /ID# 204591
City
Copenhagen Ø
State/Province
Hovedstaden
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Clinical Research Services Turku /ID# 205924
City
Turku
State/Province
Varsinais-Suomi
ZIP/Postal Code
20520
Country
Finland
Facility Name
Ita-Suomen Yliopisto /ID# 204538
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
AOU di Modena /ID# 203904
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41126
Country
Italy
Facility Name
Policlinico Agostino Gemelli /ID# 203906
City
Rome
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliera di Perugia /ID# 203905
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06129
Country
Italy
Facility Name
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli /ID# 203903
City
Brescia
ZIP/Postal Code
25125
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda /ID# 203901
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 203902
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
CGM Research Trust /ID# 204907
City
Burwood
ZIP/Postal Code
8083
Country
New Zealand
Facility Name
Fundacion CITA Alzheimer Fundazioa /ID# 204521
City
Donostia
State/Province
Pais Vasco
ZIP/Postal Code
20009
Country
Spain
Facility Name
Fundacio ACE /ID# 204520
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Clinic de Barcelona /ID# 204519
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre /ID# 204518
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Karolinska University Hospital Huddinge /ID# 203900
City
Stockholm
State/Province
Stockholms Lan
ZIP/Postal Code
171 77
Country
Sweden
Facility Name
Sahlgrenska University Hospital Molndal /ID# 203899
City
Molndal
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
431 80
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/abbvie/
Learn more about this trial
An Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD)
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