Clinical trial NCT03367403: A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)
Official title: Assessment of Safety, Tolerability and Efficacy of LY3002813 in Early Symptomatic Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Keywords: TRAILBLAZER-ALZ
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-12-08
Enrollment: 272
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability and efficacy of LY3002813 in early symptomatic Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

* Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months.
* MMSE score of 20 to 28 (inclusive) at baseline or an acceptable historical flortaucipir PET scan within 6 months prior to baseline that meets the central read criteria.
* Meet 18F flortaucipir PET scan eligibility criteria.
* Meet 18F florbetapir PET scan (central read) eligibility criteria.

Exclusion Criteria:

* Have a history of long QT syndrome.
* Have received treatment with a stable dose of an acetylcholinesterase inhibitor (AChEI) and/or memantine for less than 2 months before randomization.
* Contraindication to MRI.

Primary outcomes:
measure: Change From Baseline in the Integrated Alzheimer's Disease Rating Scale (iADRS) Score
timeFrame: Baseline, 76 Weeks
Secondary outcomes:
measure: Change From Baseline in the 13-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) Score
timeFrame: Baseline, 76 Weeks
measure: Change From Baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score
timeFrame: Baseline, 76 Weeks
measure: Change From Baseline in the Mini Mental State Examination (MMSE) Score
timeFrame: Baseline, 76 Weeks
measure: Change From Baseline in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL) Score
timeFrame: Baseline, 76 Weeks
measure: Change From Baseline in Brain Amyloid Plaque Deposition as Measured by Florbetapir F18 Positron Emission Tomography (PET) Scan
timeFrame: Baseline, 76 Weeks
measure: Change From Baseline in Brain Tau Deposition as Measured by Flortaucipir F18 PET Scan
timeFrame: Baseline, 76 Weeks
measure: Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)
timeFrame: Baseline, 76 Weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
city: Fullerton
country: United States
facility: Neurology Center of North Orange County
state: California
city: Irvine
country: United States
facility: Irvine Clinical Research Center
state: California
city: Irvine
country: United States
facility: Institute for Memory Impairment & Neurological Disorders
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: San Diego
country: United States
facility: Pacific Research Network Inc
state: California
city: San Diego
country: United States
facility: Sharp Mesa Vista Hospital
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Danbury
country: United States
facility: Associated Neurologists, PC - Danbury
state: Connecticut
city: Stamford
country: United States
facility: KI Health Partners, LLC d/b/a NE Inst. for Clin. Res.
state: Connecticut
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Bradenton
country: United States
facility: Bradenton Research Center
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Hollywood
country: United States
facility: Infinity Clinical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Merritt Island
country: United States
facility: Merritt Island Medical Research LLC
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic
state: Florida
city: Miami
country: United States
facility: Miami Jewish Health Systems
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Neurological Group
state: Florida
city: Pompano Beach
country: United States
facility: Quantum Laboratories
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Sarasota
country: United States
facility: Intercoastal Medical Group
state: Florida
city: Tampa
country: United States
facility: Axiom Research
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: The Villages
country: United States
facility: Compass Research
state: Florida
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology
state: Indiana
city: Fairway
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Clinic
state: Kansas
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
city: Methuen
country: United States
facility: ActivMed Practices & Research, Inc
state: Massachusetts
city: Newton
country: United States
facility: Boston Center for Memory
state: Massachusetts
city: Plymouth
country: United States
facility: Donald S Marks
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: Charlotte
country: United States
facility: Behavioral Health Center Research
state: North Carolina
city: Greensboro
country: United States
facility: Guilford Neurologic Associates
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research
state: North Carolina
city: Beachwood
country: United States
facility: Insight Clinical Trials
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Dayton
country: United States
facility: Neurology Diagnostics, Inc.
state: Ohio
city: Willow Grove
country: United States
facility: Abington Neurological Associates
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
city: Dallas
country: United States
facility: Texas Neurology, PA
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Bennington
country: United States
facility: The Memory Clinic
state: Vermont
city: Fairfax
country: United States
facility: Cognition Health
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research - Richmond
state: Virginia
city: Ottawa
country: Canada
facility: Bruyere Research Institute
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Regional Memory Clinic
state: Ontario
city: Toronto
country: Canada
facility: Toronto Memory Program
state: Ontario
city: Gatineau
country: Canada
facility: Clinique de la Memoire 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:
citation: Pontecorvo MJ, Lu M, Burnham SC, Schade AE, Dage JL, Shcherbinin S, Collins EC, Sims JR, Mintun MA. Association of Donanemab Treatment With Exploratory Plasma Biomarkers in Early Symptomatic Alzheimer Disease: A Secondary Analysis of the TRAILBLAZER-ALZ Randomized Clinical Trial. JAMA Neurol. 2022 Dec 1;79(12):1250-1259. doi: 10.1001/jamaneurol.2022.3392.
citation: Shcherbinin S, Evans CD, Lu M, Andersen SW, Pontecorvo MJ, Willis BA, Gueorguieva I, Hauck PM, Brooks DA, Mintun MA, Sims JR. Association of Amyloid Reduction After Donanemab Treatment With Tau Pathology and Clinical Outcomes: The TRAILBLAZER-ALZ Randomized Clinical Trial. JAMA Neurol. 2022 Oct 1;79(10):1015-1024. doi: 10.1001/jamaneurol.2022.2793.
citation: Mintun MA, Lo AC, Duggan Evans C, Wessels AM, Ardayfio PA, Andersen SW, Shcherbinin S, Sparks J, Sims JR, Brys M, Apostolova LG, Salloway SP, Skovronsky DM. Donanemab in Early Alzheimer's Disease. N Engl J Med. 2021 May 6;384(18):1691-1704. doi: 10.1056/NEJMoa2100708. Epub 2021 Mar 13.