a donanemab (ly3002813) study in participants with preclinical alzheimer's disease (trailblazer-alz 3)

Conditions: Alzheimer Disease

Summary: the main purpose of this study is to evaluate the safety and efficacy of donanemab in participants with preclinical alzheimer's disease (ad). approximately 800 additional participants will be enrolled in a 12-month addendum to assess safety of a different titration regimen.


Eligibility 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. addendum 7 exclusion criteria for clinicaltrials.gov: * same as the main study except contraindications for florbetapir f 18 pet are exclusionary.