A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)
Study Details
Study Description
Brief Summary
The main goals of this study are to further determine whether the study drug donanemab is safe and effective in participants with Alzheimer's disease and to validate video scale assessments.
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: Part A Validation of Remote Scale Assessments Alternating at-home and on-site cognitive and functional scale assessments Group 1: Cognitive/functional scale assessment at the study site (on-site), followed by an at-home assessment (VTC; video teleconference), or Group 2: Cognitive/functional scale assessment at home (VTC), followed by assessment on-site |
Other: No Intervention
No intervention
|
Other: Part B Donanemab Donanemab administered intravenously (IV) |
Drug: donanemab
Administered IV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Part A: Correlation between VTC and on-site assessment for PAIR 1 for Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) [1 Month]
Correlation between VTC and on-site assessment for PAIR 1 (defined as completing a VTC evaluation and one in person evaluation regardless of order) for the ADAS-Cog13. The ADAS-Cog13 (13-item version of ADAS Cog) assesses areas of cognitive function that are the most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze-completion measures. The ADAS-Cog13 scale ranges from 0 to 85, with higher scores indicating greater disease severity.
- Part A: Correlation between VTC and on-site assessment for PAIR 1 for Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) [1 Month]
Correlation between VTC and on-site assessment for PAIR 1 for ADCS-ADL. The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The range for the total ADCS-ADL score is 0 to 78, with lower scores indicating greater level of impairment. Alzheimer's Disease Cooperative Study Instrumental Activities of Daily Living Inventory (ADCS-iADL) is calculated from a subset of questions from the ADCS-ADL. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance.
- Part A: Correlation between VTC and on-site assessment for PAIR 1 for Mini Mental State Examination (MMSE) Score [1 Month]
Correlation between VTC and on-site assessment for PAIR 1 for MMSE. The MMSE is a brief instrument used to assess cognitive function in participants. The range for the total MMSE score is 0 to 30, with lower scores indicating greater level of impairment.
- Part A: Correlation between VTC and on-site assessment for PAIR 1 for Clinical Dementia Rating-Sum of Boxes (CDR-SB) [1 Month]
Correlation between VTC and on-site assessment for PAIR 1 for CDR-SB. The CDR-SB is a global assessment tool than can be used to effectively evaluate both cognition and function. The CDR-SB scores are calculated by adding the box scores and range from 0 to 18 (with higher scores indicative of more impairment).
- Part B: Percentage of Participants with One or More Adverse Events (AEs) or Serious AEs [Up to 72 Weeks]
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Secondary Outcome Measures
- Part B: Change from Baseline on the MMSE Score [Baseline, Week 72]
Change from Baseline on the MMSE Score. The MMSE is a brief instrument used to assess cognitive function in participants. The range for the total MMSE score is 0 to 30, with lower scores indicating greater level of impairment.
- Part B: Change from Baseline on the ADAS-Cog13 score [Baseline, Week 72]
Change from Baseline on the ADAS-Cog13. The ADAS-Cog13 (13-item version of ADAS Cog) assesses areas of cognitive function that are the most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze-completion measures. The ADAS-Cog13 scale ranges from 0 to 85, with higher scores indicating greater disease severity.
- Part B: Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) [Baseline, Week 72]
Change from Baseline on the iADRS. The iADRS is a composite that measures both cognition and function from the ADAS- Cog and the ADCS-iADL. The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 (score range 0 to 85 with higher scores reflecting worse performance) and the ADCS-iADL (score range from 0-59 with higher scores reflecting better performance). The iADRS score ranges from 0 to 144 with lower scores indicating greater impairment.
- Part B: Change from Baseline on the ADCS-iADL [Baseline, Week 72]
Change from Baseline on the ADCS-iADL. The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The range for the total ADCS-ADL score is 0 to 78, with lower scores indicating greater level of impairment. ADCS-iADL is calculated from a subset of questions from the ADCS-ADL. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance.
- Part B: Change from Baseline on the CDR-SB [Baseline, Week 72]
Change from Baseline on the CDR-SB. The CDR-SB is a global assessment tool than can be used to effectively evaluate both cognition and function. The CDR-SB scores are calculated by adding the box scores and range from 0 to 18 (with higher scores indicative of more impairment).
- Part B: Change from Baseline in Brain Amyloid Plaque Deposition as Measured by Florbetapir F18 Positron Emission Tomography (PET) Scan [Baseline, Week 72]
Change from Baseline in Brain Amyloid Plaque Deposition as Measured by Florbetapir F18 PET Scan
- Part B: Change from Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI) measures [Baseline, Week 72]
Change from Baseline in Brain Volume as Measured by vMRI
- Part B: Pharmacokinetics (PK): Average Serum Concentration of Donanemab [Predose, Up to Week 72]
PK: Average Serum Concentration of donanemab
- Part B: Number or Participants with Anti-Donanemab Antibodies [Baseline to Week 72]
Number or Participants with Anti-donanemab Antibodies
- Part B: Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) [Baseline, Week 72]
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS is a scale that captures the occurrence, severity, and frequency of suicidal ideation and behavior during the assessment period via a questionnaire. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participated in a double-blind treatment period of a sponsor-approved originating donanemab trial, for example the TRAILBLAZER-ALZ study.
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Have a study partner
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Stable symptomatic Alzheimer's Disease (AD) medications and other medication that may impact cognition for at least 30 days prior to randomization into Part A
Exclusion Criteria:
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Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with outcome assessments or the analyses in this study.
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Have received treatment with a passive anti-amyloid immunotherapy after completion of originating donanemab study or received active immunization against Aβ in any other study.
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Poor venous access
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Contraindication to PET or MRI imaging
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Banner Alzheimer's Institute | Phoenix | Arizona | United States | 85006 |
2 | Irvine Clinical Research | Irvine | California | United States | 92614 |
3 | UC Irvine-Institute for Memory Impairments and Neurological Disorders (UCI MIND) | Irvine | California | United States | 92697 |
4 | Bradenton Research Center, Inc. | Bradenton | Florida | United States | 34205 |
5 | Merritt Island Medical Research, LLC | Merritt Island | Florida | United States | 32952 |
6 | Synexus Clinical Research US, Inc - Orlando | Orlando | Florida | United States | 32806 |
7 | Advanced Research Consultants | Palm Beach Gardens | Florida | United States | 33410 |
8 | Progressive Medical Research | Port Orange | Florida | United States | 32127 |
9 | Intercoastal Medical Group | Sarasota | Florida | United States | 34239 |
10 | Stedman Clinical Trials | Tampa | Florida | United States | 33613 |
11 | Indiana University School of Medicine | Indianapolis | Indiana | United States | 46202 |
12 | Josephson Wallack Munshower Neurology, PC | Indianapolis | Indiana | United States | 46256 |
13 | The University of Kansas - Clinical Research Center | Fairway | Kansas | United States | 66205 |
14 | Cotton O'Neil Mulvane | Topeka | Kansas | United States | 66606 |
15 | Boston Center for Memory | Newton | Massachusetts | United States | 02459 |
16 | Washington University | Saint Louis | Missouri | United States | 63110 |
17 | Las Vegas Medical Research | Las Vegas | Nevada | United States | 89113 |
18 | Advanced Memory Research Institute of New Jersey | Toms River | New Jersey | United States | 08755 |
19 | Guilford Neurologic Research, PA | Greensboro | North Carolina | United States | 27405 |
20 | Ohio State University Medical Center | Columbus | Ohio | United States | 43221 |
21 | Neurology Diagnostics, Inc. | Dayton | Ohio | United States | 45459 |
22 | Abington Neurological Associates, Ltd. | Abington | Pennsylvania | United States | 19001 |
23 | Rhode Island Hospital | Providence | Rhode Island | United States | 02903 |
24 | National Clinical Research, Inc | Richmond | Virginia | United States | 23294 |
25 | Bruyère Research Institute | Ottawa | Ontario | Canada | K1N 5C8 |
26 | Toronto Memory Program | Toronto | Ontario | Canada | M3B 2S7 |
27 | Clinique de la Mémoire de l'Outaouais | Gatineau | Quebec | Canada | J8T 8J1 |
28 | Diex Recherche Sherbrooke Inc. | Sherbrooke | Quebec | Canada | J1L 0H8 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 17447
- I5T-MC-AACH