Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000268-26 | EudraCT Number |
Not provided
Not provided
Not provided
Discontinued because of lack of efficacy in the parent study (Study M15-566; NCT02880956).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in participants with early AD.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 300 mg/1000 mg Tilavonemab | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tilavonemab | Drug | solution for IV infusion |
|
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University of Arizona Medical Center Phoenix /ID# 203959 | Phoenix | Arizona | 85006 | United States | ||
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.
For details on when studies are available for sharing, please refer to the link below.
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.
Prior to enrollment, 87 participants had received tilavonemab 300 mg, 97 participants had received tilavonemab 1000 mg, 88 participants had received tilavonemab 2000 mg, and 92 participants had received placebo in the parent study.
One enrolled participant did not receive any study drug and was not included in any analysis.
A total of 364 participants who had completed the parent study (Study M15-566; NCT02880956) were enrolled into this extension study from a total of 57 sites in the United States, Australia, Belgium, Canada, Denmark, Finland, Italy, New Zealand, Spain, and Sweden.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 300 mg/1000 mg Tilavonemab | Participants who received 300 mg tilavonemab in Study M15-566 received 1000 mg tilavonemab in Study M15-570 via intravenous (IV) infusion every 4 weeks. |
| FG001 | 1000 mg/1000 mg Tilavonemab |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 20, 2020 | Aug 25, 2022 |
Not provided
Not provided
Not provided
Not provided
|
| 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. |
| Irvine Clinical Research /ID# 204000 |
| Irvine |
| California |
| 92614 |
| United States |
| Ucsd /Id# 204001 | La Jolla | California | 92037 | United States |
| University of California, San /ID# 204011 | San Francisco | California | 94143-0633 | United States |
| Brain Matters Research /ID# 203957 | Delray Beach | Florida | 33445 | United States |
| Neuropsychiatric Research Center of Southwest Florida /ID# 203956 | Fort Myers | Florida | 33912 | United States |
| Mayo Clinic /ID# 203995 | Jacksonville | Florida | 32224 | United States |
| Synexus Clinical Research US, Inc. /ID# 203992 | Orlando | Florida | 32806-1044 | United States |
| University of South Florida /ID# 204009 | Tampa | Florida | 33612 | United States |
| Synexus Clinical Research US, Inc /ID# 204010 | The Villages | Florida | 32162-7116 | United States |
| Emory University / Emory Brain Health Center /ID# 203999 | Atlanta | Georgia | 30329-2206 | United States |
| NeuroStudies.net, LLC /ID# 204004 | Decatur | Georgia | 30030 | United States |
| Advocate Lutheran General Hospital /ID# 203993 | Park Ridge | Illinois | 60068 | United States |
| Southern IL Univ School of Med /ID# 203952 | Springfield | Illinois | 62702 | United States |
| Indiana University /ID# 203989 | Indianapolis | Indiana | 46202 | United States |
| University of Kansas Medical Center - Alzheimer's Disease Center /ID# 203960 | Fairway | Kansas | 66205 | United States |
| University of Kentucky Chandler Medical Center /ID# 203996 | Lexington | Kentucky | 40536 | United States |
| Massachusetts General Hospital /ID# 203954 | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Physicians /ID# 204003 | Boston | Massachusetts | 02115 | United States |
| Hattiesburg Clinic /ID# 213435 | Hattiesburg | Mississippi | 39401 | United States |
| Princeton Medical Institute /ID# 203953 | Princeton | New Jersey | 08540 | United States |
| North Shore University Hospital /ID# 203994 | New Hyde Park | New York | 11040 | United States |
| Duke Univ Med Ctr /ID# 203958 | Durham | North Carolina | 27710 | United States |
| Oregon Health and Science University /ID# 203997 | Portland | Oregon | 97239 | United States |
| Keystone Clinical Studies LLC /ID# 213183 | Plymouth Meeting | Pennsylvania | 19462 | United States |
| Rhode Island Hospital /ID# 204005 | Providence | Rhode Island | 02903 | United States |
| Vanderbilt Ingram Cancer Center /ID# 203951 | Nashville | Tennessee | 37232-0021 | United States |
| Kerwin Research Center /ID# 203998 | Dallas | Texas | 75231-4316 | United States |
| Houston Methodist Hospital /ID# 204002 | Houston | Texas | 77030 | United States |
| McGovern Medical School /ID# 213312 | Houston | Texas | 77054 | United States |
| University of Utah /ID# 203991 | Salt Lake City | Utah | 84112-5500 | United States |
| Integrated Neurology Services /ID# 203990 | Alexandria | Virginia | 22310 | United States |
| St Vincent's Centre for Applied Medical Research /ID# 204903 | Darlinghurst | New South Wales | 2010 | Australia |
| Griffith University /ID# 204905 | Southport | Queensland | 4222 | Australia |
| Austin Health /ID# 204906 | Heidelberg | Victoria | 3084 | Australia |
| Australian Alzheimer's Res Fou /ID# 204904 | Nedlands | Western Australia | 6009 | Australia |
| UCL Saint-Luc /ID# 204963 | Woluwe-Saint-Lambert | Brussels Capital | 1200 | Belgium |
| Universitair Ziekenhuis Leuven /ID# 204965 | Leuven | Vlaams-Brabant | 3000 | Belgium |
| Groupe Sante CHC - Clinique du MontLegia /ID# 204964 | Liège | 4000 | Belgium |
| Parkwood Institute /ID# 204121 | London | Ontario | N6C 0A7 | Canada |
| Toronto Memory Program /ID# 204120 | Toronto | Ontario | M3B 2S7 | Canada |
| Rigshospitalet /ID# 204591 | Copenhagen Ø | Capital Region | 2100 | Denmark |
| Clinical Research Services Turku /ID# 205924 | Turku | Southwest Finland | 20520 | Finland |
| Ita-Suomen Yliopisto /ID# 204538 | Kuopio | 70210 | Finland |
| AOU di Modena /ID# 203904 | Modena | Emilia-Romagna | 41126 | Italy |
| Policlinico Agostino Gemelli /ID# 203906 | Rome | Lazio | 00168 | Italy |
| Azienda Ospedaliera di Perugia /ID# 203905 | Perugia | Umbria | 06129 | Italy |
| IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli /ID# 203903 | Brescia | 25125 | Italy |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 203902 | Milan | 20122 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda /ID# 203901 | Milan | 20162 | Italy |
| CGM Research Trust /ID# 204907 | Burwood | 8083 | New Zealand |
| Fundacion CITA Alzheimer Fundazioa /ID# 204521 | Donostia / San Sebastian | Basque Country | 20009 | Spain |
| Fundacio ACE /ID# 204520 | Barcelona | 08028 | Spain |
| Hospital Clinic de Barcelona /ID# 204519 | Barcelona | 08036 | Spain |
| Hospital Universitario 12 de Octubre /ID# 204518 | Madrid | 28041 | Spain |
| Karolinska University Hospital Huddinge /ID# 203900 | Stockholm | Stockholm County | 171 77 | Sweden |
| Sahlgrenska University Hospital Molndal /ID# 203899 | Mölndal | Västra Götaland County | 431 80 | Sweden |
Participants who received 1000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks.
| FG002 | 2000 mg/2000 mg Tilavonemab | Participants who received 2000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks. |
| FG003 | PBO/2000 mg Tilavonemab | Participants who received placebo (PBO) in Study M15-566 received 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Data Set: All participants who received at least 1 dose of study drug in M15-570.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 300 mg/1000 mg Tilavonemab | Participants who received 300 mg tilavonemab in Study M15-566 received 1000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks. |
| BG001 | 1000 mg/1000 mg Tilavonemab | Participants who received 1000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks. |
| BG002 | 2000 mg/2000 mg Tilavonemab | Participants who received 2000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks. |
| BG003 | PBO/2000 mg Tilavonemab | Participants who received PBO in Study M15-566 received 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety Data Set: All participants who received at least 1 dose of study drug in Study M15-570. | Posted | Count of Participants | Participants | No | From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days. |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | 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. | Safety Data Set: All participants who received at least 1 dose of study drug in Study M15-570. | Posted | Count of Participants | Participants | No | Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days. |
| ||||||||||||||||||||||||||||||||||||
| Primary | Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values | Clinical laboratory PCS criteria were adapted from NCI CTCAE version 4.03 | Safety Data Set: All participants who received at least 1 dose of study drug in Study M15-570. | Posted | Count of Participants | Participants | No | Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days. |
| ||||||||||||||||||||||||||||||||||||
| Primary | 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. | Safety Data Set: All participants who received at least 1 dose of study drug in Study M15-570. | Posted | Count of Participants | Participants | No | Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days. |
| ||||||||||||||||||||||||||||||||||||
| Primary | Brain Magnetic Resonance Imaging (MRI) Results: Number of Participants With Cerebral Edemas, New Microhemorrhage(s), and Severe White Matter Disease | Safety Data Set: All participants who received at least 1 dose of study drug in Study M15-570. Participants with postbaseline value for the respective parameter. | Posted | Count of Participants | Participants | No | Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days. |
|
All-Cause Mortality: an overall median of 353.5 days. Serious and Other Adverse Events: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 300 mg/1000 mg Tilavonemab | Participants who received 300 mg tilavonemab in Study M15-566 received 1000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks. | 2 | 87 | 16 | 87 | 26 | 87 |
| EG001 | 1000 mg/1000 mg Tilavonemab | Participants who received 1000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks. | 1 | 97 | 11 | 97 | 37 | 97 |
| EG002 | 2000 mg/2000 mg Tilavonemab | Participants who received 2000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks. | 1 | 88 | 12 | 88 | 33 | 88 |
| EG003 | PBO/2000 mg Tilavonemab | Participants who received PBO in Study M15-566 received 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks. | 0 | 91 | 10 | 91 | 26 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ARRHYTHMIA | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CARDIOPULMONARY FAILURE | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| VESTIBULAR DISORDER | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RETINAL ARTERY OCCLUSION | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| COLITIS ISCHAEMIC | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| GAIT DISTURBANCE | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BILIARY COLIC | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 PNEUMONIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| CYSTITIS ESCHERICHIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| ENTEROCOCCAL INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| ESCHERICHIA URINARY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| PNEUMONIA LEGIONELLA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| PROCEDURAL INTESTINAL PERFORATION | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| SOFT TISSUE INJURY | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| FAILURE TO THRIVE | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| BLADDER TRANSITIONAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| COLORECTAL ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| TRANSITIONAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DEMENTIA | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ENCEPHALOPATHY | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SUBARACHNOID HAEMORRHAGE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| AGGRESSION | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BEHAVIOUR DISORDER | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CHRONIC KIDNEY DISEASE | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ACUTE PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| AORTIC STENOSIS | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| AGITATION | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DELUSION | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
Study M15-570 was discontinued because of lack of efficacy in the parent study (Study M15-566) and 2) the tilavonemab development program was discontinued.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 30, 2021 | Aug 25, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000628586 | tilavonemab |
Not provided
Not provided
Not provided
| >= 65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| None |
|
| Severe TEAE |
|
| TEAE With a Reasonable Possibility of Relationship to Study Drug |
|
| Serious TEAE |
|
| TEAE Leading to Discontinuation of Study Drug |
|
| Fatal TEAE |
|
| PBO/2000 mg Tilavonemab |
Participants who received PBO in Study M15-566 received 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks. |
|
|
Participants who received PBO in Study M15-566 received 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks.
|
|
| OG002 | 2000 mg/2000 mg Tilavonemab | Participants who received 2000 mg tilavonemab in Study M15-566 were continued on the same dose in Study M15-570 via IV infusion every 4 weeks. |
| OG003 | PBO/2000 mg Tilavonemab | Participants who received PBO in Study M15-566 received 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks. |
|
|
Participants who received PBO in Study M15-566 received 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks.
|
|