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Clinical Trials in the USA / NCT05026866
Active, not recruiting Phase 3

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

NCT05026866 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2021-08-27
Last updated
2026-01-21

Condition(s) studied

Alzheimer Disease

Investigational drug(s) / intervention(s)

DonanemabPlacebo

Donanemab: Administered intravenously

Placebo: Administered intravenously

Study summary

The main purpose of this study is to evaluate the safety and efficacy of donanemab in participants with preclinical Alzheimer's Disease (AD) over up to 332 weeks. Approximately 800 additional participants will be enrolled in the 12-month Addendum 7 to assess safety of a different titration regimen.

Eligibility

Sex
ALL
Min age
55 Years
Max age
80 Years
Healthy volunteers
No
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 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. Treatment Extension: (Study Period II Placebo Group Only) * Are actively participating in Study AACM at the conclusion of Study Period III. 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 (Aβ) in any other study. * Have received active immunization against Aβ in any other study. * Current or previous use of prescription medications used as treatment for mild cognitive impairment (MCI) or AD. Addendum 7 Exclusion Criteria: * Same as the main study except contraindications for florbetapir F 18 PET are exclusionary.

Primary outcome measure(s)

Trial sites (216)

FacilityCityRegionStatus
Parkway Medical Center Birmingham Alabama
Alabama Psychiatry - Birmingham - Brookwood Medical Center Drive Homewood Alabama
Rehabilitation & Neurological Services Huntsville Alabama
Care Access - 801 South Power Road, Mesa Mesa Arizona
Banner Alzheimer's Institute Phoenix Arizona
Banner Alzheimer's Institute Tucson Tucson Arizona
Center for Neurosciences Tucson Arizona
Care Access - Berkeley Berkeley California
Care Access - Beverly Hills Beverly Hills California
Velocity Clinical Research, Chula Vista Chula Vista California
Valley Clinical Trials, Inc. Covina California
Neurology Center of North Orange County Fullerton California
Care Access - Gilroy Gilroy California
Marvel Clinical Research Huntington Beach California
Care Access Research - Huntington Beach Huntington Beach California
Irvine Clinical Research Irvine California
Option Care - Irvine Irvine California
Kaizen Brain Center La Jolla California
Velocity Clinical Research, San Diego La Mesa California
Pacific Research Network Lemon Grove California
Healthy Brain Clinic Long Beach California
Neurovations Napa California
Care Access - Newport Beach Newport Beach California
Valley Clinical Trials, Inc. Northridge California
Inland Psychiatric Medical Group Redlands California
Anderson Clinical Research Redlands California
Artemis Institute for Clinical Research Riverside California
Option Care - Riverside Riverside California
Clinical Trials Research Sacramento California
Artemis Institute for Clinical Research San Diego California
Ray Dolby Brain Health Center San Francisco California
Care Access - Los Gatos San Jose California
Syrentis Clinical Research Santa Ana California
Care Access - Santa Clarita Santa Clarita California
Option Care - Los Angeles South Santa Fe Springs California
Providence Medical Foundation Santa Rosa California
Mazur, Statner, Dutta, Nathan, PC Thousand Oaks California
Tilda Research Tustin California
Velocity Clinical Research, Panorama City Van Nuys California
Infectious Disease Doctors Medical Group, APC Walnut Creek California

+ 176 more sites — see the full list on the official registry below.

On this site

📄 Kisunla (donanemab) drug profile →

More Eli Lilly and Company trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05026866 on ClinicalTrials.gov ↗ ← All trials in the USA