A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05108922 |
|
Recruitment Status :
Active, not recruiting
First Posted : November 5, 2021
Last Update Posted : January 19, 2023
|
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The main purpose of this study is to compare donanemab to aducanumab on amyloid plaque clearance in participants with early symptomatic Alzheimer's Disease (AD).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Mild Cognitive Impairment Alzheimer Disease | Drug: Donanemab Drug: Aducanumab | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Open-Label, Parallel-Group, 2-Arm Study to Investigate Amyloid Plaque Clearance With Donanemab Compared With Aducanumab-avwa in Participants With Early Symptomatic Alzheimer's Disease |
| Actual Study Start Date : | November 16, 2021 |
| Actual Primary Completion Date : | September 9, 2022 |
| Estimated Study Completion Date : | July 2, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Alzheimer disease
Drug Information available for:
Aducanumab
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Donanemab
Donanemab is administered intravenously (IV) every 4 weeks (Q4W)
|
Drug: Donanemab
Administered IV
Other Name: LY3002813 |
|
Active Comparator: Aducanumab
Aducanumab administered IV per label
|
Drug: Aducanumab
Administered IV |
Primary Outcome Measures :
- Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 Positron Emission Tomography (PET) Scan (Superiority) on donanemab versus aducanumab [ Time Frame: 6 Months ]Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
- Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Intermediate Subpopulation (Superiority) on donanemab versus aducanumab [ Time Frame: 6 Months ]Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the intermediate subpopulation (Superiority) on donanemab versus aducanumab
Secondary Outcome Measures :
- Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab [ Time Frame: Baseline, 6 Months ]Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
- Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab [ Time Frame: Baseline, 12 Months ]Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
- Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab [ Time Frame: Baseline, 18 Months ]Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
- Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Noninferiority) on donanemab 6 months versus aducanumab 12 months [ Time Frame: Baseline, 6 Months, 12 Months ]Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Noninferiority) on donanemab 6 months versus aducanumab 12 months
- Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Noninferiority) donanemab 6 months versus aducanumab 18 months [ Time Frame: Baseline, 6 Months, 18 Months ]Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Noninferiority) donanemab 6 months versus aducanumab 18 months
- Time to Reach Complete Amyloid Plaque Clearance on donanemab versus aducanumab [ Time Frame: Baseline to 18 Months ]Time to reach complete amyloid plaque clearance on donanemab versus aducanumab
- Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) donanemab versus aducanumab [ Time Frame: Baseline, 6 Months ]Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) donanemab versus aducanumab
- Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab [ Time Frame: Baseline, 12 Months ]Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
- Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab [ Time Frame: Baseline, 18 Months ]Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
- Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab [ Time Frame: 12 Months ]Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
- Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab [ Time Frame: 18 Months ]Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
- Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab [ Time Frame: 12 Months ]Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
- Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab [ Time Frame: 18 Months ]Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
- Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab [ Time Frame: Baseline, 6 Months ]Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
- Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab [ Time Frame: Baseline, 12 Months ]Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
- Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab [ Time Frame: Baseline, 18 Months ]Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
- Change from Baseline in Brain Amyloid Plaque Reduction on Florbetapir F18 PET Scan (Superiority) donanemab 6 months versus aducanumab 12 months [ Time Frame: Baseline, 6 Months, 12 Months ]Change from Baseline in Brain Amyloid Plaque Reduction on Florbetapir F18 PET Scan (Superiority) donanemab 6 months versus aducanumab 12 months
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 50 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Gradual and progressive change in memory function reported by the participant or informant for ≥6 months.
- Meet florbetapir F18 PET scan criteria.
- A Clinical Dementia Rating (CDR)-Global Score of 0.5 or 1.
- Must consent to apolipoprotein E (ApoE) genotyping
- Must have a mini mental state examination (MMSE) score between 20 and 30
- Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to study visits or be available by telephone at designated times.
- Have adequate literacy, vision, and hearing for neuropsychological testing in the opinion of the investigator at the time of screening.
- Women not of childbearing potential may participate
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05108922
Locations
Show 31 study locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | 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 |
Additional Information:
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT05108922 |
| Other Study ID Numbers: |
18369 I5T-MC-AACN ( Other Identifier: Eli Lilly and Company ) |
| First Posted: | November 5, 2021 Key Record Dates |
| Last Update Posted: | January 19, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
| Time Frame: | 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. |
| Access Criteria: | A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement. |
| URL: | http://vivli.org/ |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Eli Lilly and Company:
|
Mild Cognitive Impairment due to Alzheimer's Disease |
Additional relevant MeSH terms:
|
Alzheimer Disease Cognitive Dysfunction Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Cognition Disorders |