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

• Status: Recruiting
• Trial end date: 2027-09-25
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

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 (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.