Clinical trial NCT04640077: A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)
Official title: Donanemab Follow-On Study: Safety, Tolerability, And Efficacy in Symptomatic Alzheimer's Disease With Validation of Remote Neuropsychological Assessments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Cognitive Impairment
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-11-23
Enrollment: 95
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 neuropsychological assessments administered over videoconferencing


Eligibility criteria: 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 Aβ in any other study.
* Poor venous access
* Contraindication to PET or MRI imaging

Primary outcomes:
measure: Part A: Intraclass Correlation Between On-Site and Video Teleconference (VTC) Assessments
timeFrame: Baseline to 4 Weeks
measure: Part B: Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline Up To 96 Weeks
measure: Part B: Number of Participants With Suicidality Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline, Week 72
Secondary outcomes:
measure: Part B: Change From Baseline on the Mini Mental State Examination (MMSE) Score
timeFrame: Baseline, Week 72
measure: Part B: Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score
timeFrame: Baseline, Week 72
measure: Part B: Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)
timeFrame: Baseline, Week 72
measure: Part B: Change From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL)
timeFrame: Baseline, Week 72
measure: Part B: Change From Baseline on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
timeFrame: Baseline, Week 72
measure: Part B: Change From Baseline in Brain Amyloid Plaque Deposition as Measured by Florbetapir F18 Positron Emission Tomography (PET) Scan
timeFrame: Baseline, Week 36
measure: Part B: Change From Baseline in Whole Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)
timeFrame: Baseline, Week 72
measure: Part B: Pharmacokinetics (PK): Trough Concentrations of Donanemab (Ctrough)
timeFrame: Predose at Week 8 and Week 16
measure: Part B: Number or Participants With Treatment-Emergent Anti-Drug Antibodies (TE ADA) of Donanemab
timeFrame: Baseline, 4, 8, 16, 24, 36, 48, 60, 72, 84, and 96 Weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Irvine
country: United States
facility: UC Irvine-Institute for Memory Impairments and Neurological Disorders (UCI MIND)
state: California
city: Bradenton
country: United States
facility: Bradenton Research Center, Inc.
state: Florida
city: Merritt Island
country: United States
facility: Merritt Island Medical Research, LLC
state: Florida
city: Orlando
country: United States
facility: Synexus Clinical Research US, Inc.
state: Florida
city: Palm Beach Gardens
country: United States
facility: Advanced Research Consultants
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Sarasota
country: United States
facility: Intercoastal Medical Group - Hyde Park
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology, PC
state: Indiana
city: Fairway
country: United States
facility: The University of Kansas - Clinical Research Center
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center - Central Office
state: Kansas
city: Newton
country: United States
facility: Boston Center for Memory
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Toms River
country: United States
facility: Advanced Memory Research Institute of New Jersey
state: New Jersey
city: Greensboro
country: United States
facility: Guilford Neurologic Research, PA
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Dayton
country: United States
facility: Neurology Diagnostics, Inc.
state: Ohio
city: Abington
country: United States
facility: Abington Neurological Associates, Ltd.
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Richmond
country: United States
facility: National Clinical Research, Inc
state: Virginia
city: Ottawa
country: Canada
facility: Bruyère Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Toronto Memory Program
state: Ontario
city: Gatineau
country: Canada
facility: Clinique de la Mémoire de l'Outaouais
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke Inc.
state: Quebec
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: