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TerminatedPhase 2Results posted

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

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

Lead sponsor

AbbVie

Asset

Tilavonemab

Listed sites

57

Recruiting sites

-

Enrollment

364

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoints

•Treatment Emergent Adverse Events (TEAEs), Serious TEAEs•Hematology•Clinical Chemistry

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2018-000268-26
Org study IDM15-570
NCT IDNCT03712787

Timeline

Milestones

Study first posted2018-10-19actual
Study start2019-03-22actual
Primary completion2021-09-30actual
Study completion2021-09-30actual
Last update posted2022-09-22actual
Results first posted2022-09-22actual

Assets

Drug assets

Tilavonemab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age57 Years
Maximum age88 Years
SexAll
Healthy volunteersNot accepted

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)

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
4
Behavior / neuropsychiatric
2
Neuroimaging
2
Other (unclassified)
2

Behavior / neuropsychiatric

2 endpoints
Primary/protocol endpoint

Columbia-Suicide Severity Rating Scale (C-SSRS) During Double-Blind Treatment Period

Time frame:Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.

event count, event

Primary/registry result

Columbia-Suicide Severity Rating Scale (C-SSRS) During Double-Blind Treatment Period

Time frame:Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
300 mg/1000 mg TilavonemabSuicidal behaviors or ideationsn=87 Participants4-
Suicidal behaviorsn=87 Participants0-
Suicidal ideationsn=87 Participants4-
Suicidal ideations only (No Suicidal Behavior)n=87 Participants4-
1000 mg/1000 mg TilavonemabSuicidal behaviors or ideationsn=97 Participants3-
Suicidal behaviorsn=97 Participants0-
Suicidal ideationsn=97 Participants3-
Suicidal ideations only (No Suicidal Behavior)n=97 Participants3-
2000 mg/2000 mg TilavonemabSuicidal behaviors or ideationsn=88 Participants8-
Suicidal behaviorsn=88 Participants0-
Suicidal ideationsn=88 Participants8-
Suicidal ideations only (No Suicidal Behavior)n=88 Participants8-
PBO/2000 mg TilavonemabSuicidal behaviors or ideationsn=91 Participants4-
Suicidal behaviorsn=91 Participants0-
Suicidal ideationsn=91 Participants4-
Suicidal ideations only (No Suicidal Behavior)n=91 Participants4-

Neuroimaging

2 endpoints
Primary/protocol endpoint

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.

event count, event

Primary/registry result

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.

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
300 mg/1000 mg TilavonemabCerebral Edemasn=79 Participants1-
Questionable Cerebral Edemasn=79 Participants0-
New Microhemorrhage(s)n=79 Participants4-
Severe White Matter Diseasen=79 Participants9-
1000 mg/1000 mg TilavonemabCerebral Edemasn=84 Participants1-
Questionable Cerebral Edemasn=84 Participants1-
New Microhemorrhage(s)n=84 Participants5-
Severe White Matter Diseasen=84 Participants5-
2000 mg/2000 mg TilavonemabCerebral Edemasn=79 Participants0-
Questionable Cerebral Edemasn=79 Participants0-
New Microhemorrhage(s)n=79 Participants11-
Severe White Matter Diseasen=79 Participants6-
PBO/2000 mg TilavonemabCerebral Edemasn=78 Participants0-
Questionable Cerebral Edemasn=78 Participants0-
New Microhemorrhage(s)n=78 Participants5-
Severe White Matter Diseasen=78 Participants5-

Safety / tolerability / PK

4 endpoints
Primary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Study Drug, and Fatal TEAEs

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.

event count, event

Primary/protocol endpoint

Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values

Time frame:Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.

event count, event

Primary/registry result

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Study Drug, and Fatal TEAEs

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.

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
300 mg/1000 mg TilavonemabAny TEAEn=87 Participants54-
Severe TEAEn=87 Participants9-
TEAE With a Reasonable Possibility of Relationship to Study Drugn=87 Participants7-
Serious TEAEn=87 Participants16-
TEAE Leading to Discontinuation of Study Drugn=87 Participants2-
Fatal TEAEn=87 Participants1-
1000 mg/1000 mg TilavonemabAny TEAEn=97 Participants66-
Severe TEAEn=97 Participants8-
TEAE With a Reasonable Possibility of Relationship to Study Drugn=97 Participants10-
Serious TEAEn=97 Participants11-
TEAE Leading to Discontinuation of Study Drugn=97 Participants4-
Fatal TEAEn=97 Participants1-
2000 mg/2000 mg TilavonemabAny TEAEn=88 Participants59-
Severe TEAEn=88 Participants10-
TEAE With a Reasonable Possibility of Relationship to Study Drugn=88 Participants15-
Serious TEAEn=88 Participants12-
TEAE Leading to Discontinuation of Study Drugn=88 Participants0-
Fatal TEAEn=88 Participants1-
PBO/2000 mg TilavonemabAny TEAEn=91 Participants57-
Severe TEAEn=91 Participants7-
TEAE With a Reasonable Possibility of Relationship to Study Drugn=91 Participants5-
Serious TEAEn=91 Participants10-
TEAE Leading to Discontinuation of Study Drugn=91 Participants5-
Fatal TEAEn=91 Participants0-
Primary/registry result

Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values

Time frame:Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
300 mg/1000 mg TilavonemabHemoglobin - Low (< 100 g/L)n=87 Participants1-
Hemoglobin - High (> 40 g/L above Upper Limit of Normal [ULN])n=87 Participants0-
Platelets - Low (< 75 × 10^9/L)n=87 Participants0-
Leukocytes - Low (< 2 × 10^9/L)n=87 Participants0-
Leukocytes - High (> 100 × 10^9/L)n=87 Participants0-
Neutrophils - Low (< 1 × 10^9/L)n=87 Participants1-
Lymphocytes - Low (< 0.5 × 10^9/L)n=87 Participants0-
Lymphocytes - High (> 20 × 10^9/L)n=87 Participants0-
Activated Partial Thromboplastin Time (> ULN)n=87 Participants0-
Prothrombin International Normalized Ratio (> ULN)n=87 Participants0-
1000 mg/1000 mg TilavonemabHemoglobin - Low (< 100 g/L)n=97 Participants0-
Hemoglobin - High (> 40 g/L above Upper Limit of Normal [ULN])n=97 Participants0-
Platelets - Low (< 75 × 10^9/L)n=97 Participants0-
Leukocytes - Low (< 2 × 10^9/L)n=97 Participants0-
Leukocytes - High (> 100 × 10^9/L)n=97 Participants0-
Neutrophils - Low (< 1 × 10^9/L)n=97 Participants0-
Lymphocytes - Low (< 0.5 × 10^9/L)n=97 Participants0-
Lymphocytes - High (> 20 × 10^9/L)n=97 Participants0-
Activated Partial Thromboplastin Time (> ULN)n=97 Participants0-
Prothrombin International Normalized Ratio (> ULN)n=97 Participants0-
2000 mg/2000 mg TilavonemabHemoglobin - Low (< 100 g/L)n=88 Participants2-
Hemoglobin - High (> 40 g/L above Upper Limit of Normal [ULN])n=88 Participants0-
Platelets - Low (< 75 × 10^9/L)n=88 Participants0-
Leukocytes - Low (< 2 × 10^9/L)n=88 Participants0-
Leukocytes - High (> 100 × 10^9/L)n=88 Participants0-
Neutrophils - Low (< 1 × 10^9/L)n=88 Participants0-
Lymphocytes - Low (< 0.5 × 10^9/L)n=88 Participants1-
Lymphocytes - High (> 20 × 10^9/L)n=88 Participants0-
Activated Partial Thromboplastin Time (> ULN)n=88 Participants0-
Prothrombin International Normalized Ratio (> ULN)n=88 Participants0-
PBO/2000 mg TilavonemabHemoglobin - Low (< 100 g/L)n=91 Participants1-
Hemoglobin - High (> 40 g/L above Upper Limit of Normal [ULN])n=91 Participants0-
Platelets - Low (< 75 × 10^9/L)n=91 Participants0-
Leukocytes - Low (< 2 × 10^9/L)n=91 Participants0-
Leukocytes - High (> 100 × 10^9/L)n=91 Participants0-
Neutrophils - Low (< 1 × 10^9/L)n=91 Participants0-
Lymphocytes - Low (< 0.5 × 10^9/L)n=91 Participants0-
Lymphocytes - High (> 20 × 10^9/L)n=91 Participants0-
Activated Partial Thromboplastin Time (> ULN)n=91 Participants0-
Prothrombin International Normalized Ratio (> ULN)n=91 Participants0-

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values

Time frame:Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.

threshold achievement, improvement

Primary/registry result/low confidence

Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values

Time frame:Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.

threshold achievement, improvement

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
300 mg/1000 mg TilavonemabAlanine Aminotransferase (> 3 × ULN)n=87 Participants0-
Aspartate Aminotransferase (> 3 × ULN)n=87 Participants0-
Alkaline Phosphatase (> 2.5 × ULN)n=87 Participants0-
Bilirubin (> 1.5 × ULN)n=87 Participants0-
Creatinine (> 1.5 × ULN)n=87 Participants0-
Calcium - Low (< 1.75 mmol/L)n=87 Participants0-
Calcium - High (> 3.1 mmol/L)n=87 Participants0-
Sodium - Low (< 130 mmol/L)n=87 Participants0-
Sodium - High (> 155 mmol/L)n=87 Participants0-
Potassium - Low (< 3 mmol/L)n=87 Participants0-
Potassium - High (> 6 mmol/L)n=87 Participants0-
Glucose - Low (< 2.2 mmol/L)n=87 Participants0-
Glucose - High (> 13.9 mmol/L)n=87 Participants0-
Albumin (< 20 g/L)n=87 Participants0-
Cholesterol (> 12.92 mmol/L)n=87 Participants0-
Triglycerides (> 5.7 mmol/L)n=87 Participants0-
Phosphate (< 0.6 mmol/L)n=87 Participants0-
Uric acid (> 590 μmol/L)n=87 Participants0-
1000 mg/1000 mg TilavonemabAlanine Aminotransferase (> 3 × ULN)n=97 Participants0-
Aspartate Aminotransferase (> 3 × ULN)n=97 Participants0-
Alkaline Phosphatase (> 2.5 × ULN)n=97 Participants0-
Bilirubin (> 1.5 × ULN)n=97 Participants0-
Creatinine (> 1.5 × ULN)n=97 Participants0-
Calcium - Low (< 1.75 mmol/L)n=97 Participants0-
Calcium - High (> 3.1 mmol/L)n=97 Participants0-
Sodium - Low (< 130 mmol/L)n=97 Participants1-
Sodium - High (> 155 mmol/L)n=97 Participants0-
Potassium - Low (< 3 mmol/L)n=97 Participants0-
Potassium - High (> 6 mmol/L)n=97 Participants0-
Glucose - Low (< 2.2 mmol/L)n=97 Participants0-
Glucose - High (> 13.9 mmol/L)n=97 Participants0-
Albumin (< 20 g/L)n=97 Participants0-
Cholesterol (> 12.92 mmol/L)n=97 Participants0-
Triglycerides (> 5.7 mmol/L)n=97 Participants0-
Phosphate (< 0.6 mmol/L)n=97 Participants0-
Uric acid (> 590 μmol/L)n=97 Participants0-
2000 mg/2000 mg TilavonemabAlanine Aminotransferase (> 3 × ULN)n=88 Participants0-
Aspartate Aminotransferase (> 3 × ULN)n=88 Participants0-
Alkaline Phosphatase (> 2.5 × ULN)n=88 Participants0-
Bilirubin (> 1.5 × ULN)n=88 Participants1-
Creatinine (> 1.5 × ULN)n=88 Participants0-
Calcium - Low (< 1.75 mmol/L)n=88 Participants0-
Calcium - High (> 3.1 mmol/L)n=88 Participants0-
Sodium - Low (< 130 mmol/L)n=88 Participants0-
Sodium - High (> 155 mmol/L)n=88 Participants0-
Potassium - Low (< 3 mmol/L)n=88 Participants0-
Potassium - High (> 6 mmol/L)n=88 Participants0-
Glucose - Low (< 2.2 mmol/L)n=88 Participants0-
Glucose - High (> 13.9 mmol/L)n=88 Participants0-
Albumin (< 20 g/L)n=88 Participants0-
Cholesterol (> 12.92 mmol/L)n=88 Participants0-
Triglycerides (> 5.7 mmol/L)n=88 Participants1-
Phosphate (< 0.6 mmol/L)n=88 Participants0-
Uric acid (> 590 μmol/L)n=88 Participants0-
PBO/2000 mg TilavonemabAlanine Aminotransferase (> 3 × ULN)n=91 Participants0-
Aspartate Aminotransferase (> 3 × ULN)n=91 Participants0-
Alkaline Phosphatase (> 2.5 × ULN)n=91 Participants0-
Bilirubin (> 1.5 × ULN)n=91 Participants1-
Creatinine (> 1.5 × ULN)n=91 Participants0-
Calcium - Low (< 1.75 mmol/L)n=91 Participants0-
Calcium - High (> 3.1 mmol/L)n=91 Participants0-
Sodium - Low (< 130 mmol/L)n=91 Participants1-
Sodium - High (> 155 mmol/L)n=91 Participants0-
Potassium - Low (< 3 mmol/L)n=91 Participants0-
Potassium - High (> 6 mmol/L)n=91 Participants0-
Glucose - Low (< 2.2 mmol/L)n=91 Participants0-
Glucose - High (> 13.9 mmol/L)n=91 Participants1-
Albumin (< 20 g/L)n=91 Participants0-
Cholesterol (> 12.92 mmol/L)n=91 Participants0-
Triglycerides (> 5.7 mmol/L)n=91 Participants0-
Phosphate (< 0.6 mmol/L)n=91 Participants0-
Uric acid (> 590 μmol/L)n=91 Participants0-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.