A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)

Alzheimer Disease Clinical Trial

Official title:

Donanemab Follow-On Study: Safety, Tolerability, And Efficacy in Symptomatic Alzheimer's Disease With Validation of Remote Neuropsychological Assessments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04640077
• Other study ID #: 17447
• Secondary ID: I5T-MC-AACH
• Status: Completed
• Phase: Phase 2
• Start date: November 23, 2020
• Est. completion date: February 27, 2024

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: February 27, 2024
• Est. primary completion date: February 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

Inclusion Criteria:

• Participated in a double-blind treatment period of a sponsor-approved originating donanemab trial, for example the TRAILBLAZER-ALZ study.

• Have a study partner

• 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:

• 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.

• Have received treatment with a passive anti-amyloid immunotherapy after completion of originating donanemab study or received active immunization against Aß in any other study.

• Poor venous access

• Contraindication to PET or MRI imaging

Related Conditions & MeSH terms

• Alzheimer Disease
• Brain Diseases
• Central Nervous System Diseases
• Cognitive Impairment
• Dementia
• Nervous System Diseases

Intervention

Other:
• No Intervention
No intervention

Drug:
• donanemab
Administered IV

Locations

Country	Name	City	State
Canada	Clinique de la Mémoire de l'Outaouais	Gatineau	Quebec
Canada	Bruyère Research Institute	Ottawa	Ontario
Canada	Diex Recherche Sherbrooke Inc.	Sherbrooke	Quebec
Canada	Toronto Memory Program	Toronto	Ontario
United States	Abington Neurological Associates, Ltd.	Abington	Pennsylvania
United States	Bradenton Research Center, Inc.	Bradenton	Florida
United States	Ohio State University	Columbus	Ohio
United States	Neurology Diagnostics, Inc.	Dayton	Ohio
United States	The University of Kansas - Clinical Research Center	Fairway	Kansas
United States	Guilford Neurologic Research, PA	Greensboro	North Carolina
United States	Indiana University	Indianapolis	Indiana
United States	Josephson Wallack Munshower Neurology, PC	Indianapolis	Indiana
United States	UC Irvine-Institute for Memory Impairments and Neurological Disorders (UCI MIND)	Irvine	California
United States	Las Vegas Medical Research	Las Vegas	Nevada
United States	Merritt Island Medical Research, LLC	Merritt Island	Florida
United States	Boston Center for Memory	Newton	Massachusetts
United States	Synexus Clinical Research US, Inc.	Orlando	Florida
United States	Advanced Research Consultants	Palm Beach Gardens	Florida
United States	Banner Alzheimer's Institute	Phoenix	Arizona
United States	Progressive Medical Research	Port Orange	Florida
United States	Rhode Island Hospital	Providence	Rhode Island
United States	National Clinical Research, Inc	Richmond	Virginia
United States	Washington University	Saint Louis	Missouri
United States	Intercoastal Medical Group - Hyde Park	Sarasota	Florida
United States	Stedman Clinical Trials	Tampa	Florida
United States	Advanced Memory Research Institute of New Jersey	Toms River	New Jersey
United States	Cotton O'Neil Clinical Research Center - Central Office	Topeka	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Correlation between VTC and on-site assessment for PAIR 1 for Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)	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.	1 Month
Primary	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)	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.	1 Month
Primary	Part A: Correlation between VTC and on-site assessment for PAIR 1 for Mini Mental State Examination (MMSE) Score	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.	1 Month
Primary	Part A: Correlation between VTC and on-site assessment for PAIR 1 for Clinical Dementia Rating-Sum of Boxes (CDR-SB)	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).	1 Month
Primary	Part B: Percentage of Participants with One or More Adverse Events (AEs) or Serious AEs	A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.	Up to 72 Weeks
Secondary	Part B: Change from Baseline on the MMSE Score	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.	Baseline, Week 72
Secondary	Part B: Change from Baseline on the ADAS-Cog13 score	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.	Baseline, Week 72
Secondary	Part B: Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)	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.	Baseline, Week 72
Secondary	Part B: Change from Baseline on the ADCS-iADL	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.	Baseline, Week 72
Secondary	Part B: Change from Baseline on the CDR-SB	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).	Baseline, Week 72
Secondary	Part B: Change from Baseline in Brain Amyloid Plaque Deposition as Measured by Florbetapir F18 Positron Emission Tomography (PET) Scan	Change from Baseline in Brain Amyloid Plaque Deposition as Measured by Florbetapir F18 PET Scan	Baseline, Week 72
Secondary	Part B: Change from Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI) measures	Change from Baseline in Brain Volume as Measured by vMRI	Baseline, Week 72
Secondary	Part B: Pharmacokinetics (PK): Average Serum Concentration of Donanemab	PK: Average Serum Concentration of donanemab	Predose, Up to Week 72
Secondary	Part B: Number or Participants with Anti-Donanemab Antibodies	Number or Participants with Anti-donanemab Antibodies	Baseline to Week 72
Secondary	Part B: Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)	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).	Baseline, Week 72

External Links

•   A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)