Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I5T-MC-AACN | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to compare donanemab to aducanumab on brain amyloid plaque clearance in participants with early symptomatic Alzheimer's Disease (AD).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donanemab | Experimental | Donanemab is administered intravenously (IV) every 4 weeks (Q4W). |
|
| Aducanumab | Active Comparator | Aducanumab administered IV per US label. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donanemab | Drug | Participants received 700 milligram (mg) donanemab administered by intravenous (IV) infusion every 4 weeks (Q4W) for first three doses and then 1400 mg IV Q4W. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 Positron Emission Tomography (PET) Scan (Superiority) on Donanemab Versus Aducanumab | Amyloid deposition in the brain is one of the defining neuropathologic findings of Alzheimer's disease (AD). Amyloid PET scan assesses cerebral amyloid load using florbetapir tracer which is standardized into Centiloids for evaluation of AD. Florbetapir exhibits high affinity specific binding to amyloid plaques. Centiloid values on Centiloid scale is based on mean composite Standardized Uptake Value Ratio (SUVR) in cingulate, frontal, parietal and temporal cortexes using whole cerebellum as reference region. SUVR is ratio of tracer uptake in each of cingulate, frontal, parietal and temporal cortexes relative to cerebellum. Complete brain amyloid plaque clearance is a binary outcome and is defined as a Centiloid value <24.1 from the florbetapir F18 PET scan. | 6 Months |
| Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Low/Medium (Intermediate) Subpopulation (Superiority) on Donanemab Versus Aducanumab | Complete brain amyloid plaque clearance is a binary outcome and is defined as a Centiloid value <24.1 from the florbetapir F18 PET scan. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Absolute Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on Donanemab Versus Aducanumab | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Significant neurological disease affecting the central nervous system (other than AD), that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, history of transient ischemic attack or stroke, or epilepsy or recurrent seizures (except febrile childhood seizures).
Current serious or unstable medical illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, psychiatric (including actively suicidal or deemed at risk of suicide, or current alcohol or substance abuse), immunologic, infectious, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of approximately
≤24 months.
History of clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions (including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and/or exfoliative dermatitis).
History of bleeding disorder or use of medications with platelet anti-aggregant or anti-coagulant properties (unless aspirin at ≤325 milligram (mg).
Have had prior or current treatment with donanemab or aducanumab
Have known allergies to donanemab or aducanumab, related compounds, or any components of the formulation
Prior or current participation in any immunotherapy study targeting Amyloid beta
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-2559) or 1-317-615-4559 Mon - Fri 9 am - 5 pm Eastern time (UTC/GMT) - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurology Center of North Orange County | Fullerton | California | 92835 | United States | ||
| Irvine Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41804324 | Derived | Ardayfio P, Mullins GR, Khanna R, Zimmer JA, Wang H, Nery ESM, Evans CD, Piela P, Battioui C, Lauzon S, Anglin G, Ng HW, Jayaraman AR, Agada N, Natalie CR, Brooks DA, Sims JR. Infusion-related reactions in donanemab-treated participants with early symptomatic Alzheimer's disease. Alzheimers Dement (N Y). 2026 Mar 8;12(1):e70229. doi: 10.1002/trc2.70229. eCollection 2026 Jan-Mar. | |
| 40390253 |
| Label | URL |
|---|---|
| A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4) | View source |
Not provided
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Aducanumab | Participants received aducanumab administered by intravenous (IV) infusion per US label (prescribing information/routine clinical practice). |
| FG001 | Donanemab | Participants received 700 milligram (mg) donanemab administered by IV infusion every 4 weeks (Q4W) for first three doses and then 1400 mg IV Q4W. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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 | May 17, 2022 | Aug 25, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Aducanumab | Drug | Participants received aducanumab administered by IV infusion per US label (prescribing information/routine clinical practice). |
|
| Baseline, 6 Months |
| Mean Percent Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) Donanemab Versus Aducanumab | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. | Baseline, 6 Months |
| Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Low/Medium (Intermediate) Tau Subpopulation (Superiority) on Donanemab Versus Aducanumab | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. | Baseline, 6 Months |
| Mean Absolute Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on Donanemab Versus Aducanumab | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. | Baseline, 12 Months |
| Mean Percent Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) Donanemab Versus Aducanumab | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. | Baseline, 12 Months |
| Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 Positron Emission Tomography (PET) Scan (Superiority) on Donanemab Versus Aducanumab | Amyloid deposition in the brain is one of the defining neuropathologic findings of Alzheimer's disease (AD). Amyloid PET scan assesses cerebral amyloid load using florbetapir tracer which is standardized into Centiloids for evaluation of AD. Florbetapir exhibits high affinity specific binding to amyloid plaques. Centiloid values on Centiloid scale is based on mean composite Standardized Uptake Value Ratio (SUVR) in cingulate, frontal, parietal and temporal cortexes using whole cerebellum as reference region. SUVR is ratio of tracer uptake in each of cingulate, frontal, parietal and temporal cortexes relative to cerebellum. Complete brain amyloid plaque clearance is a binary outcome and is defined as a Centiloid value <24.1 from the florbetapir F18 PET scan. | 12 Months |
| Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Low/Medium (Intermediate) Subpopulation (Superiority) on Donanemab Versus Aducanumab | Amyloid deposition in the brain is one of the defining neuropathologic findings of Alzheimer's disease (AD). Amyloid PET scan assesses cerebral amyloid load using florbetapir tracer which is standardized into Centiloids for evaluation of AD. Florbetapir exhibits high affinity specific binding to amyloid plaques. Centiloid values on Centiloid scale is based on mean composite Standardized Uptake Value Ratio (SUVR) in cingulate, frontal, parietal and temporal cortexes using whole cerebellum as reference region. SUVR is ratio of tracer uptake in each of cingulate, frontal, parietal and temporal cortexes relative to cerebellum. Complete brain amyloid plaque clearance is a binary outcome and is defined as a Centiloid value <24.1 from the florbetapir F18 PET scan. | 12 Months |
| Mean Absolute Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Low/Medium (Intermediate) Tau Subpopulation (Superiority) on Donanemab Versus Aducanumab | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. | Baseline, 12 Months |
| Mean Absolute Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on Donanemab 6 Months Versus Aducanumab 12 Months | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. | Baseline, 6 Months and 12 Months |
| Mean Absolute Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Non-inferiority) on Donanemab 6 Months Versus Aducanumab 12 Months | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. | Baseline, 6 Months and 12 Months |
| Mean Absolute Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on Donanemab Versus Aducanumab | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. | Baseline, 18 Months |
| Time to Reach Complete Amyloid Plaque Clearance on Donanemab Versus Aducanumab | Time to reach complete amyloid plaque clearance at 18 months was evaluated. | 18 Months |
| Mean Percent Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) Donanemab Versus Aducanumab | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. | Baseline, 18 Months |
| Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 Positron Emission Tomography (PET) Scan (Superiority) on Donanemab Versus Aducanumab | Amyloid deposition in the brain is one of the defining neuropathologic findings of Alzheimer's disease (AD). Amyloid PET scan assesses cerebral amyloid load using florbetapir tracer which is standardized into Centiloids for evaluation of AD. Florbetapir exhibits high affinity specific binding to amyloid plaques. Centiloid values on Centiloid scale is based on mean composite Standardized Uptake Value Ratio (SUVR) in cingulate, frontal, parietal and temporal cortexes using whole cerebellum as reference region. SUVR is ratio of tracer uptake in each of cingulate, frontal, parietal and temporal cortexes relative to cerebellum. Complete brain amyloid plaque clearance is a binary outcome and is defined as a Centiloid value <24.1 from the florbetapir F18 PET scan. | 18 Months |
| Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Low/Medium (Intermediate) Subpopulation (Superiority) on Donanemab Versus Aducanumab | Complete brain amyloid plaque clearance is a binary outcome and is defined as a Centiloid value <24.1 from the florbetapir F18 PET scan. | 18 Months |
| Mean Absolute Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Low/Medium (Intermediate) Tau Subpopulation (Superiority) on Donanemab Versus Aducanumab | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. | Baseline, 18 Months |
| Mean Absolute Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Non-inferiority) on Donanemab 6 Months Versus Aducanumab 18 Months | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. | Baseline, 6 Months and 18 Months |
| Irvine |
| California |
| 92614 |
| United States |
| California Neuroscience Research Medical Group, Inc. | Sherman Oaks | California | 91403 | United States |
| Institute for Neurodegenerative Disorders | New Haven | Connecticut | 06510 | United States |
| JEM Research Institute | Atlantis | Florida | 33462 | United States |
| Brain Matters Research | Delray Beach | Florida | 33445 | United States |
| Neuropsychiatric Research Center of Southwest Florida | Fort Myers | Florida | 33912 | United States |
| Infinity Clinical Research, LLC | Hollywood | Florida | 33024 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Charter Research - Lady Lake | Lady Lake | Florida | 32159 | United States |
| ClinCloud - Maitland | Maitland | Florida | 32751 | United States |
| ClinCloud - Viera | Melbourne | Florida | 32940 | United States |
| Merritt Island Medical Research, LLC | Merritt Island | Florida | 32952 | United States |
| Optimus U Corporation | Miami | Florida | 33125 | United States |
| Brainstorm Research | Miami | Florida | 33176 | United States |
| Brain Matters Research | Stuart | Florida | 34997 | United States |
| Axiom Clinical Research of Florida | Tampa | Florida | 33609 | United States |
| Conquest Research | Winter Park | Florida | 32789 | United States |
| Columbus Memory Center, PC | Columbus | Georgia | 31909 | United States |
| Josephson Wallack Munshower Neurology, PC | Indianapolis | Indiana | 46256 | United States |
| Donald S. Marks M.D., P.C. | Plymouth | Massachusetts | 02360 | United States |
| Adams Clinical | Watertown | Massachusetts | 02472 | United States |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | United States |
| Las Vegas Medical Research | Las Vegas | Nevada | 89113 | United States |
| The Cognitive and Research Center of New Jersey | Springfield | New Jersey | 07081 | United States |
| Advanced Memory Research Institute of New Jersey | Toms River | New Jersey | 08755 | United States |
| Neurology Diagnostics, Inc. | Dayton | Ohio | 45459 | United States |
| Abington Neurological Associates, Ltd. | Abington | Pennsylvania | 19001 | United States |
| The Clinical Trial Center, LLC | Jenkintown | Pennsylvania | 19046 | United States |
| Kerwin Medical Center | Dallas | Texas | 75231 | United States |
| National Clinical Research, Inc | Richmond | Virginia | 23294 | United States |
| Derived |
| Salloway S, Pain A, Lee E, Papka M, Ferguson MB, Wang H, Hu H, Lu M, Oru E, Ardayfio PA, Hoban DB, Collins EC, Brooks DA, Sims JR. TRAILBLAZER-ALZ 4: A phase 3 trial comparing donanemab with aducanumab on amyloid plaque clearance in early, symptomatic Alzheimer's disease. Alzheimers Dement. 2025 May;21(5):e70293. doi: 10.1002/alz.70293. |
| Received at Least One Dose of Study Drug |
|
| Intermediate Tau Analysis Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Aducanumab | Participants received aducanumab administered by IV infusion per US label (prescribing information/routine clinical practice). |
| BG001 | Donanemab | Participants received 700 mg donanemab administered by IV infusion Q4W for first three doses and then 1400 mg IV Q4W. |
| BG002 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | 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 | Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 Positron Emission Tomography (PET) Scan (Superiority) on Donanemab Versus Aducanumab | Amyloid deposition in the brain is one of the defining neuropathologic findings of Alzheimer's disease (AD). Amyloid PET scan assesses cerebral amyloid load using florbetapir tracer which is standardized into Centiloids for evaluation of AD. Florbetapir exhibits high affinity specific binding to amyloid plaques. Centiloid values on Centiloid scale is based on mean composite Standardized Uptake Value Ratio (SUVR) in cingulate, frontal, parietal and temporal cortexes using whole cerebellum as reference region. SUVR is ratio of tracer uptake in each of cingulate, frontal, parietal and temporal cortexes relative to cerebellum. Complete brain amyloid plaque clearance is a binary outcome and is defined as a Centiloid value <24.1 from the florbetapir F18 PET scan. | All randomized participants who received at least one dose of study drug to donanemab or aducanumab with a baseline and at least one postbaseline Florbetapir F18 PET scan data at the primary outcome (6-month) database lock. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 Months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Low/Medium (Intermediate) Subpopulation (Superiority) on Donanemab Versus Aducanumab | Complete brain amyloid plaque clearance is a binary outcome and is defined as a Centiloid value <24.1 from the florbetapir F18 PET scan. | All randomized participants who received at least one dose of study drug to donanemab or aducanumab with a baseline and at least one postbaseline Florbetapir F18 PET scan data and a baseline flortaucipir F18 PET scan meeting the low/medium tau criteria at the primary outcome (6-month) database lock. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Absolute Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on Donanemab Versus Aducanumab | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. | All randomized participants who received at least one dose of study drug to donanemab or aducanumab with a baseline and at least one postbaseline Florbetapir F18 PET scan data at the primary outcome (6-month) database lock. | Posted | Least Squares Mean | Standard Error | Centiloids | Baseline, 6 Months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Percent Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) Donanemab Versus Aducanumab | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. | All randomized participants who received at least one dose of study drug to donanemab or aducanumab with a baseline and at least one postbaseline Florbetapir F18 PET scan data at the primary outcome (6-month) database lock. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline, 6 Months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Low/Medium (Intermediate) Tau Subpopulation (Superiority) on Donanemab Versus Aducanumab | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. | All randomized participants who received at least one dose of study drug to donanemab or aducanumab with a baseline and at least one postbaseline Florbetapir F18 PET scan data and a baseline flortaucipir F18 PET scan meeting the low/medium tau criteria at the primary outcome (6-month) database lock. | Posted | Least Squares Mean | Standard Error | Centiloids | Baseline, 6 Months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Absolute Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on Donanemab Versus Aducanumab | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. | All randomized participants who received at least one dose of study drug to donanemab or aducanumab with a baseline and at least one postbaseline Florbetapir F18 PET scan data at the 12-month database lock. | Posted | Least Squares Mean | Standard Error | Centiloids | Baseline, 12 Months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Percent Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) Donanemab Versus Aducanumab | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. | All randomized participants who received at least one dose of study drug to donanemab or aducanumab with a baseline and at least one postbaseline Florbetapir F18 PET scan data at the 12-month database lock. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline, 12 Months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 Positron Emission Tomography (PET) Scan (Superiority) on Donanemab Versus Aducanumab | Amyloid deposition in the brain is one of the defining neuropathologic findings of Alzheimer's disease (AD). Amyloid PET scan assesses cerebral amyloid load using florbetapir tracer which is standardized into Centiloids for evaluation of AD. Florbetapir exhibits high affinity specific binding to amyloid plaques. Centiloid values on Centiloid scale is based on mean composite Standardized Uptake Value Ratio (SUVR) in cingulate, frontal, parietal and temporal cortexes using whole cerebellum as reference region. SUVR is ratio of tracer uptake in each of cingulate, frontal, parietal and temporal cortexes relative to cerebellum. Complete brain amyloid plaque clearance is a binary outcome and is defined as a Centiloid value <24.1 from the florbetapir F18 PET scan. | All randomized participants who received at least one dose of study drug to donanemab or aducanumab with a baseline and at least one postbaseline Florbetapir F18 PET scan data at the 12-month database lock. | Posted | Number | Percentage of participants | 12 Months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Low/Medium (Intermediate) Subpopulation (Superiority) on Donanemab Versus Aducanumab | Amyloid deposition in the brain is one of the defining neuropathologic findings of Alzheimer's disease (AD). Amyloid PET scan assesses cerebral amyloid load using florbetapir tracer which is standardized into Centiloids for evaluation of AD. Florbetapir exhibits high affinity specific binding to amyloid plaques. Centiloid values on Centiloid scale is based on mean composite Standardized Uptake Value Ratio (SUVR) in cingulate, frontal, parietal and temporal cortexes using whole cerebellum as reference region. SUVR is ratio of tracer uptake in each of cingulate, frontal, parietal and temporal cortexes relative to cerebellum. Complete brain amyloid plaque clearance is a binary outcome and is defined as a Centiloid value <24.1 from the florbetapir F18 PET scan. | All randomized participants who received at least one dose of study drug to donanemab or aducanumab with a baseline and at least one postbaseline Florbetapir F18 PET scan data and a baseline flortaucipir F18 PET scan meeting the low/medium tau criteria at the 12-month database lock. | Posted | Number | percentage of participants | 12 Months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Absolute Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Low/Medium (Intermediate) Tau Subpopulation (Superiority) on Donanemab Versus Aducanumab | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. | All randomized participants who received at least one dose of study drug to donanemab or aducanumab with a baseline and at least one postbaseline Florbetapir F18 PET scan data and a baseline flortaucipir F18 PET scan meeting the low/medium tau criteria at the 12-month database lock. | Posted | Least Squares Mean | Standard Error | Centiloids | Baseline, 12 Months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Absolute Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on Donanemab 6 Months Versus Aducanumab 12 Months | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. | All randomized participants who received at least one dose of study drug to donanemab or aducanumab with a baseline and at least one postbaseline Florbetapir F18 PET scan data at the 12-month database lock. | Posted | Least Squares Mean | Standard Error | Centiloids | Baseline, 6 Months and 12 Months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Absolute Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Non-inferiority) on Donanemab 6 Months Versus Aducanumab 12 Months | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. | All randomized participants who received at least one dose of study drug to donanemab or aducanumab with a baseline and at least one postbaseline Florbetapir F18 PET scan data at the 12-month database lock. | Posted | Least Squares Mean | Standard Error | Centiloids | Baseline, 6 Months and 12 Months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Absolute Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on Donanemab Versus Aducanumab | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. | All randomized participants who received at least one dose of study drug to donanemab or aducanumab with a baseline and at least one postbaseline Florbetapir F18 PET scan data at the 12-month database lock. | Posted | Least Squares Mean | Standard Error | Centiloids | Baseline, 18 Months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Reach Complete Amyloid Plaque Clearance on Donanemab Versus Aducanumab | Time to reach complete amyloid plaque clearance at 18 months was evaluated. | All randomized participants who received at least one dose of study drug to donanemab or aducanumab with a baseline and at least one postbaseline Florbetapir F18 PET scan data at the 12-month database lock. | Posted | Median | 95% Confidence Interval | days | 18 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Percent Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) Donanemab Versus Aducanumab | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. | All randomized participants who received at least one dose of study drug to donanemab or aducanumab with a baseline and at least one postbaseline Florbetapir F18 PET scan data at the 12-month database lock. | Posted | Least Squares Mean | Standard Error | percent change | Baseline, 18 Months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 Positron Emission Tomography (PET) Scan (Superiority) on Donanemab Versus Aducanumab | Amyloid deposition in the brain is one of the defining neuropathologic findings of Alzheimer's disease (AD). Amyloid PET scan assesses cerebral amyloid load using florbetapir tracer which is standardized into Centiloids for evaluation of AD. Florbetapir exhibits high affinity specific binding to amyloid plaques. Centiloid values on Centiloid scale is based on mean composite Standardized Uptake Value Ratio (SUVR) in cingulate, frontal, parietal and temporal cortexes using whole cerebellum as reference region. SUVR is ratio of tracer uptake in each of cingulate, frontal, parietal and temporal cortexes relative to cerebellum. Complete brain amyloid plaque clearance is a binary outcome and is defined as a Centiloid value <24.1 from the florbetapir F18 PET scan. | All randomized participants who received at least one dose of study drug to donanemab or aducanumab with a baseline and at least one postbaseline Florbetapir F18 PET scan data at the 12-month database lock. | Posted | Number | percentage of participants | 18 Months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Low/Medium (Intermediate) Subpopulation (Superiority) on Donanemab Versus Aducanumab | Complete brain amyloid plaque clearance is a binary outcome and is defined as a Centiloid value <24.1 from the florbetapir F18 PET scan. | All randomized participants who received at least one dose of study drug to donanemab or aducanumab with a baseline and at least one postbaseline Florbetapir F18 PET scan data and a baseline flortaucipir F18 PET scan meeting the low/medium tau criteria at the 12-month database lock. | Posted | Number | percentage of participants | 18 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Absolute Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Low/Medium (Intermediate) Tau Subpopulation (Superiority) on Donanemab Versus Aducanumab | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. | All randomized participants who received at least one dose of study drug to donanemab or aducanumab with a baseline and at least one postbaseline Florbetapir F18 PET scan data and a baseline flortaucipir F18 PET scan meeting the low/medium tau criteria at the 12-month database lock. | Posted | Least Squares Mean | Standard Error | Centiloids | Baseline, 18 Months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Absolute Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Non-inferiority) on Donanemab 6 Months Versus Aducanumab 18 Months | Florbetapir PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline. | All randomized participants who received at least one dose of study drug to donanemab or aducanumab with a baseline and at least one postbaseline Florbetapir F18 PET scan data at the 12-month database lock. | Posted | Least Squares Mean | Standard Error | Centiloids | Baseline, 6 Months and 18 Months |
|
Baseline Up to Week 76
All randomized participants who received at least one dose of study drug to donanemab or aducanumab. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
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 | Aducanumab | Participants received aducanumab administered by IV infusion per US label (prescribing information/routine clinical practice). | 0 | 69 | 8 | 69 | 59 | 69 |
| EG001 | Donanemab | Participants received 700 mg donanemab administered by IV infusion Q4W for first three doses and then 1400 mg IV Q4W. | 0 | 71 | 13 | 71 | 58 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Amyloid related imaging abnormality-oedema/effusion | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lymphocytosis | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Macular hole | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Retinal tear | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Visual field defect | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gingival swelling | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Loose tooth | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Parotid duct obstruction | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Infusion site reaction | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Mass | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Campylobacter infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Fungal foot infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Immunisation reaction | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Ocular procedural complication | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Shoulder fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Traumatic haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Biopsy prostate | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic enzyme abnormal | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Sars-cov-2 test positive | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Vitamin b12 decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Muscle discomfort | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Osteoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Amyloid related imaging abnormality-oedema/effusion | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Brain fog | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebral microhaemorrhage | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Head discomfort | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nerve compression | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Paralysis | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Superficial siderosis of central nervous system | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Unresponsive to stimuli | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Affective disorder | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Apathy | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Initial insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertonic bladder | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Obstructive sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Epiretinal membrane peel | Surgical and medical procedures | MedDRA 26.0 | Systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA 26.0 | Systematic Assessment |
| |
| Large intestinal polypectomy | Surgical and medical procedures | MedDRA 26.0 | Systematic Assessment |
| |
| Skin neoplasm excision | Surgical and medical procedures | MedDRA 26.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Peripheral artery aneurysm | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 24, 2021 | Aug 25, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000729112 | donanemab |
| C000600266 | aducanumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
Participants received 700 mg donanemab administered by IV infusion Q4W for first three doses and then 1400 mg IV Q4W.
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|