A Donanemab (LY3002813) Prevention Study in Participants With Alzheimer's Disease (TRAILBLAZER-ALZ 3)

Alzheimer Disease Clinical Trial

Official title:

A Study of Donanemab Versus Placebo in Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05026866
• Other study ID #: 18284
• Secondary ID: I5T-MC-AACM
• Status: Recruiting
• Phase: Phase 3
• Start date: August 27, 2021
• Est. completion date: November 8, 2027

Study information

• Verified date: June 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate the safety and efficacy of donanemab in participants with preclinical Alzheimer's Disease (AD).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2600
• Est. completion date: November 8, 2027
• Est. primary completion date: November 8, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

Inclusion Criteria:

• A Telephone Interview for Cognitive Status - modified (TICS-M) score reflective of intact cognitive functioning.

• Has a phosphorylated tau (P-tau) result consistent with the presence of amyloid and early-tau pathology.

• Has a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.

• Have adequate literacy, vision, and hearing for neuropsychological testing at screening.

• Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

• Female participants include those who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as Mullerian agenesis; or post menopausal (women 55 or older not on hormone therapy and had at least 12 months of spontaneous amenorrhea; or with a diagnosis of menopause prior to starting hormone replacement therapy.

Exclusion Criteria:

• Mild cognitive impairment or dementia, or significant other neurodegenerative disease that can affect cognition.

• Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease that could interfere with the analysis of the study or a life expectancy of approximately =5 years.

• History of cancer with high risk of recurrence and preventing completion of the trial.

• 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).

• Have any clinically important abnormality at screening on magnetic resonance imaging (MRI) or clinical laboratory test results that could be detrimental to the participant or study integrity.

• Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.

• Have a centrally read MRI demonstrating presence of amyloid-related imaging abnormalities (ARIA-E), >4 cerebral microhemorrhages, more than 1 area of superficial siderosis, any macrohemorrhage or severe white matter disease at screening.

• Have had prior treatment with a passive anti-amyloid immunotherapy <5 half-lives prior to randomization.

• Have received active immunization against amyloid beta (Aß) in any other study.

• Have received active immunization against Aß in any other study.

• Current or previous use of prescription medications used as treatment for mild cognitive impairment (MCI) or AD.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Donanemab
Administered intravenously
• Placebo
Administered intravenously

Locations

Country	Name	City	State
Japan	The University of Tokyo Hospital	Bunkyo-ku	Tokyo
Japan	Fukuwa Clinic	Chuo-ku	Tokyo
Japan	Tokyo-Eki Center-building Clinic	Chuo-ku	Tokyo
Japan	P-One Clinic	Hachioji	Tokyo
Japan	Tokyo Metropolitan Geriatric Hospital	Itabashi	Tokyo
Japan	National Center for Geriatrics and Gerontology	Obu	Aichi
Japan	AMC Nishiumeda Clinic	Osaka
Japan	Samoncho Clinic	Shinjuku	Tokyo
Japan	Heishinkai Medical Group ToCROM Clinic	Shinjuku-ku	Tokyo
Japan	Medical Corporation Heishinkai OCROM Clinic	Suita-shi	Osaka
Japan	Tokyo Asbo Clinic	Tokyo
Japan	Oita University Hospital	Yufu	Oita
Puerto Rico	SCB Research Center	Bayamon
Puerto Rico	Dr. Samuel Sanchez PSC	Caguas
Puerto Rico	INSPIRA Clinical Research	San Juan
Puerto Rico	Instituto De Neurologia Dra. Ivonne Fraga	San Juan
Puerto Rico	Mindful Medical Research	San Juan
Puerto Rico	University of Puerto Rico - Medical Sciences Campus_Do not use - Duplicate facility	San Juan
United States	IMA Clinical Research - Albany	Albany	New York
United States	Neurological Associates Albany	Albany	New York
United States	Albuquerque Neuroscience Inc.	Albuquerque	New Mexico
United States	Care Access - Anderson	Anderson	South Carolina
United States	Velocity Clinical Research, Anderson	Anderson	South Carolina
United States	Care Access - Arlington	Arlington	Virginia
United States	Asheville Neurology Specialists	Asheville	North Carolina
United States	JEM Research Institute	Atlantis	Florida
United States	Masters of Clinical Research	Augusta	Georgia
United States	Care Access - Aurora	Aurora	Colorado
United States	Senior Adults Specialty Research	Austin	Texas
United States	Texas Diabetes & Endocrinology, P.A.	Austin	Texas
United States	VIN-Julie Schwartzbard	Aventura	Florida
United States	Option Care - Bakersfield	Bakersfield	California
United States	Mountain Neurological Research Center	Basalt	Colorado
United States	Optum Infusion - Baton Rouge	Baton Rouge	Louisiana
United States	Gadolin Research	Beaumont	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Optum Infusion - Bend	Bend	Oregon
United States	The Memory Clinic	Bennington	Vermont
United States	Care Access - Berkeley	Berkeley	California
United States	Care Access - Beverly Hills	Beverly Hills	California
United States	Parkway Medical Center	Birmingham	Alabama
United States	Excel Medical Clinical Trials	Boca Raton	Florida
United States	Neurology Offices of South Florida	Boca Raton	Florida
United States	SFM Clinical Research	Boca Raton	Florida
United States	Northwest Clinical Trials	Boise	Idaho
United States	Citizens Memorial Hospital District	Bolivar	Missouri
United States	Bradenton Research Center, Inc.	Bradenton	Florida
United States	Prime Global Research	Bronx	New York
United States	Headlands Research - Brownsville	Brownsville	Texas
United States	Minneapolis Clinic of Neurology - Burnsville Office	Burnsville	Minnesota
United States	NeuroScience Research Center	Canton	Ohio
United States	Option Care - Chantilly	Chantilly	Virginia
United States	Option Care - Charleston WV	Charleston	West Virginia
United States	Clinical Research Professionals	Chesterfield	Missouri
United States	Great Lakes Clinical Trials - Andersonville	Chicago	Illinois
United States	IMA Clinical Research - Chicago	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Uptown Research Institute	Chicago	Illinois
United States	Velocity Clinical Research, Chula Vista	Chula Vista	California
United States	Wellnow Urgent Care and Research	Cincinnati	Ohio
United States	Clinical Research of West Florida, Inc. (Clearwater)	Clearwater	Florida
United States	Optum Infusion - Columbia	Columbia	Maryland
United States	VitaLink Research - Columbia	Columbia	South Carolina
United States	Conroe Willis Medical Research	Conroe	Texas
United States	Neurology Clinic, P.C.	Cordova	Tennessee
United States	Valley Clinical Trials, Inc.	Covina	California
United States	Neurology Diagnostics, Inc.	Dayton	Ohio
United States	Care Access - Daytona Beach	Daytona Beach	Florida
United States	iResearch Atlanta	Decatur	Georgia
United States	Care Access - Delray Beach	Delray Beach	Florida
United States	Colorado Neurological Research Center, PC	Denver	Colorado
United States	Care Access - Dorchester	Dorchester	Massachusetts
United States	Clarity Clinical Research	East Syracuse	New York
United States	Advanced Neuro Research Center - ANRC	El Paso	Texas
United States	AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research	Elk Grove Village	Illinois
United States	Care Access - Fairview Heights	Fairview Heights	Illinois
United States	SKY Clinical Research Network Group - Hall	Fayette	Mississippi
United States	Care Access - Fayetteville	Fayetteville	North Carolina
United States	Coram CVS/Specialty Infusion Services - Fort Wayne	Fort Wayne	Indiana
United States	Neurology Center of North Orange County	Fullerton	California
United States	Velocity Clinical Research, Gaffney	Gaffney	South Carolina
United States	Center for Advanced Research & Education	Gainesville	Georgia
United States	Care Access - Georgetown	Georgetown	Texas
United States	Care Access - Gilroy	Gilroy	California
United States	Finlay Medical Research	Greenacres City	Florida
United States	Care Access - Greensboro	Greensboro	North Carolina
United States	Medication Management	Greensboro	North Carolina
United States	VitaLink Research - Greenville	Greenville	South Carolina
United States	Great Lakes Clinical Trials - Gurnee	Gurnee	Illinois
United States	IMA Clinical Research - Hartsdale	Hartsdale	New York
United States	Coram CVS/Specialty Infusion Services - Henderson	Henderson	Nevada
United States	Indago Research & Health Center, Inc	Hialeah	Florida
United States	IMA Clinical Research Hoboken	Hoboken	New Jersey
United States	Infinity Clinical Research, LLC	Hollywood	Florida
United States	Alabama Psychiatry - Birmingham - Brookwood Medical Center Drive	Homewood	Alabama
United States	Next Level Urgent Care	Houston	Texas
United States	Optum Infusion - Houston	Houston	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	Care Access Research - Huntington Beach	Huntington Beach	California
United States	Rehabilitation & Neurological Services	Huntsville	Alabama
United States	Care Access - Indianapolis	Indianapolis	Indiana
United States	Care Access - South Indianapolis	Indianapolis	Indiana
United States	Josephson Wallack Munshower Neurology, PC	Indianapolis	Indiana
United States	Irvine Clinical Research	Irvine	California
United States	Option Care - Irvine	Irvine	California
United States	Optum Infusion - Irving	Irving	Texas
United States	Option Care - Chicago	Itasca	Illinois
United States	Coram CVS/Specialty Infusion Services - Jacksonville	Jacksonville	Florida
United States	Encore Research Group- Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	The Clinical Trial Center, LLC	Jenkintown	Pennsylvania
United States	Care Access - Kinston	Kinston	North Carolina
United States	Kaizen Brain Center	La Jolla	California
United States	Velocity Clinical Research, San Diego	La Mesa	California
United States	Care Access - Guava Street	Lady Lake	Florida
United States	Care Access - Lake Charles	Lake Charles	Louisiana
United States	Accel Research Sites Network - St. Pete-Largo Clinical Research Unit	Largo	Florida
United States	Las Vegas Medical Research	Las Vegas	Nevada
United States	Option Care - Las Vegas	Las Vegas	Nevada
United States	Care Access - Lima	Lima	Ohio
United States	Accellacare - DuPage	Lombard	Illinois
United States	Healthy Brain Clinic	Long Beach	California
United States	Norton Brownsboro Hospital	Louisville	Kentucky
United States	ClinCloud - Maitland	Maitland	Florida
United States	K2 Medical Research	Maitland	Florida
United States	Care Access - Mauldin	Mauldin	South Carolina
United States	Family Practice Center	McAllen	Texas
United States	Velocity Clinical Research, Medford	Medford	Oregon
United States	Suburban Research Associates	Media	Pennsylvania
United States	ClinCloud - Viera	Melbourne	Florida
United States	Clinical Neuroscience Solutions, Inc. dba CNS Healthcare	Memphis	Tennessee
United States	Merritt Island Medical Research, LLC	Merritt Island	Florida
United States	Care Access - 801 South Power Road, Mesa	Mesa	Arizona
United States	ActivMed Practices and Research	Methuen	Massachusetts
United States	Finlay Medical Research	Miami	Florida
United States	IMIC, Inc.	Miami	Florida
United States	Optimus U Corporation	Miami	Florida
United States	The Neurology Research Group	Miami	Florida
United States	VIN-Andrew Lerman	Miami	Florida
United States	VIN-Victor Faradji	Miami	Florida
United States	San Marcus Research Clinic, Inc.	Miami Lakes	Florida
United States	South Florida Research Phase I-IV	Miami Springs	Florida
United States	North Star Medical Research	Middleburg Heights	Ohio
United States	Monroe Biomedical Research	Monroe	North Carolina
United States	Carteret Medical Group	Morehead City	North Carolina
United States	Exemplar Research	Morgantown	West Virginia
United States	Adult Medicine of Lake County	Mount Dora	Florida
United States	Neurovations	Napa	California
United States	Invicro	New Haven	Connecticut
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	IMA Clinical Research	New York	New York
United States	Care Access - Newport Beach	Newport Beach	California
United States	Boston Center for Memory	Newton	Massachusetts
United States	Valley Clinical Trials, Inc.	Northridge	California
United States	Renstar Medical Research	Ocala	Florida
United States	Coram CVS/Specialty Infusion Services - Ontario	Ontario	California
United States	Charter Research - Winter Park	Orlando	Florida
United States	Headlands Research Orlando	Orlando	Florida
United States	College Park Specialty Center	Overland Park	Kansas
United States	MD Medical Research	Oxon Hill	Maryland
United States	Velocity Clinical Research, Panorama City	Panorama City	California
United States	South Shore Neurologic Associates	Patchogue	New York
United States	Pines Care Research Center, LLC	Pembroke Pines	Florida
United States	VIN- Margarita Almeida El-Ramey	Pembroke Pines	Florida
United States	Emerald Coast Neurology - Airport Boulevard	Pensacola	Florida
United States	Banner Alzheimer's Institute	Phoenix	Arizona
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	Care Access - Charlotte	Pineville	North Carolina
United States	Care Access - Youngstown	Poland	Ohio
United States	Progressive Medical Research	Port Orange	Florida
United States	Center for Cognitive Health	Portland	Oregon
United States	Care Access - Pottsville	Pottsville	Pennsylvania
United States	Care Access - Raleigh	Raleigh	North Carolina
United States	Health Concepts	Rapid City	South Dakota
United States	Anderson Clinical Research	Redlands	California
United States	Inland Psychiatric Medical Group	Redlands	California
United States	Dominion Medical Associates, Inc.	Richmond	Virginia
United States	SKY Clinical Research Network Group-Quinn	Ridgeland	Mississippi
United States	El Faro Health and Therapeutics	Rio Grande City	Texas
United States	Artemis Institute for Clinical Research	Riverside	California
United States	Option Care - Riverside	Riverside	California
United States	Optum Infusion - Roseville	Roseville	Minnesota
United States	Clinical Trials Research	Sacramento	California
United States	Option Care - Sacramento	Sacramento	California
United States	IMA Clinical Research - St. Louis	Saint Louis	Missouri
United States	Benchmark Research - Knickerbocker	San Angelo	Texas
United States	Diagnostics Research Group	San Antonio	Texas
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Coram CVS/Specialty Infusion Services - San Diego	San Diego	California
United States	Pacific Research Network	San Diego	California
United States	Ray Dolby Brain Health Center	San Francisco	California
United States	Care Access - Los Gatos	San Jose	California
United States	Syrentis Clinical Research	Santa Ana	California
United States	Care Access - Santa Clarita	Santa Clarita	California
United States	Option Care - Los Angeles South	Santa Fe Springs	California
United States	Providence Medical Foundation	Santa Rosa	California
United States	Option Care - St. Cloud	Sauk Rapids	Minnesota
United States	Meridian Clinical Research, LLC	Savannah	Georgia
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	VitaLink Research - Spartanburg	Spartanburg	South Carolina
United States	Coram CVS/Specialty Infusion Services - Spokane Valley	Spokane Valley	Washington
United States	The Cognitive and Research Center of New Jersey	Springfield	New Jersey
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Revival Research Institute	Sterling Heights	Michigan
United States	Care Access - Pebble Beach Boulevard, Tampa	Sun City	Florida
United States	Universal Research Group	Tacoma	Washington
United States	Care Access - Tamarac	Tamarac	Florida
United States	Clinical Research of West Florida	Tampa	Florida
United States	Coram CVS/Specialty Infusion Services - Tampa	Tampa	Florida
United States	K2 Medical Research - Tampa	Tampa	Florida
United States	Stedman Clinical Trials	Tampa	Florida
United States	Vicis Clinical Research	Tampa	Florida
United States	Charter Research - Lady Lake	The Villages	Florida
United States	Mazur, Statner, Dutta, Nathan, PC	Thousand Oaks	California
United States	Banner Alzheimer's Institute Tucson	Tucson	Arizona
United States	Center for Neurosciences	Tucson	Arizona
United States	Central States Research	Tulsa	Oklahoma
United States	Tilda Research	Tustin	California
United States	VitaLink Research - Union	Union	South Carolina
United States	Rophe Adult and Pediatric Medicine/SKYCRNG	Union City	Georgia
United States	Infectious Disease Doctors Medical Group, APC	Walnut Creek	California
United States	MedVadis Research Corporation	Waltham	Massachusetts
United States	IMA Clinical Research Warren	Warren	New Jersey
United States	Care Access Research - Warwick	Warwick	Rhode Island
United States	Covenant Medical Center	Waterloo	Iowa
United States	Texas Valley Clinical Research	Weslaco	Texas
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Accellacare - Winston-Salem	Winston-Salem	North Carolina
United States	Conquest Research	Winter Park	Florida
United States	Optum Infusion - Woodinville	Woodinville	Washington
United States	North Georgia Clinical Research	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Japan,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to clinical progression as measured by Clinical Dementia Rating - Global Score (CDR-GS)	Time to clinical progression as measured by CDR-GS. CDR is a clinician-rated scale that provides an overall assessment of the participant's stage on the spectrum of AD dementia.	Estimated Up to Week 182
Secondary	Change from Baseline in International Shopping List Test (ISLT)	Change from Baseline in clinical progression as measured by ISLT in participants with preclinical AD.	Baseline, Up to Week 182
Secondary	Change from Baseline in Continuous Paired Associate Learning (CPAL)	Change from Baseline in clinical progression as measured by CPAL in participants with preclinical AD.	Baseline, Up to Week 182
Secondary	Change from Baseline in International Daily Symbol Substitution Test-Medicines (iDSSTm)	Change from Baseline in clinical progression as measured by iDSSTm in participants with preclinical AD.	Baseline, Up to Week 182
Secondary	Change from Baseline in Category Fluency	Change from Baseline in clinical progression as measured by Category Fluency in participants with preclinical AD.	Baseline, Up to Week 182
Secondary	Change from Baseline in Face Name Association Test (FNAME)	Change from Baseline in clinical progression as measured by FNAME in participants with preclinical AD.	Baseline, Up to Week 182
Secondary	Change from Baseline in Behavioral Pattern Separation-Object test (BPS-O)	Change from Baseline in clinical progression as measured by BPS-O in participants with preclinical AD.	Baseline, Up to Week 182
Secondary	Change from Baseline in Cogstate Brief Battery (CBB)	Change from Baseline in clinical progression as measured by CBB in participants with preclinical AD.	Baseline, Up to Week 182
Secondary	Change from Baseline in CDR-Sum of Boxes (CDR-SB)	Change from Baseline in clinical progression as measured by CDR-SB in participants with preclinical AD.	Baseline, Up Week 32
Secondary	Change from Baseline in Cognitive Function Index (CFI)	Change from Baseline in clinical progression as measured by CFI in participants with preclinical AD.	Baseline, Up to Week 182
Secondary	Change from Baseline in Montreal Cognitive Assessment (MoCA) score	Change from Baseline in clinical progression as measured by MoCA score in participants with preclinical AD.	Baseline, Up to Week 182
Secondary	Pharmacokinetics (PK): Average Serum Donanemab Concentration at Steady State	PK: Average Serum Donanemab Concentration at Steady State	Baseline through Week 76
Secondary	Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs)	Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs)	Baseline through Week 16

External Links

•   A Donanemab (LY3002813) Prevention Study in Participants With Alzheimer's Disease (TRAILBLAZER-ALZ 3)