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

Inclusion Criteria:

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

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

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

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

• Contraceptive use by men or women should be consistent with local regulationsregarding 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 suchas Mullerian agenesis; or post menopausal (women 55 or older not on hormone therapyand had at least 12 months of spontaneous amenorrhea; or with a diagnosis ofmenopause prior to starting hormone replacement therapy.

Exclusion Criteria:

• Mild cognitive impairment or dementia, or significant other neurodegenerativedisease 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 thestudy or a life expectancy of approximately ≤5 years.

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

• History of clinically significant multiple or severe drug allergies, or severeposttreatment hypersensitivity reactions (including but not limited to erythemamultiforme 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 theparticipant or study integrity.

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

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

• Have had prior treatment with a passive anti-amyloid immunotherapy <5 half-livesprior 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 mildcognitive impairment (MCI) or AD.

Addendum 7 Exclusion Criteria for Clinicaltrials.gov:

• Same as the main study except contraindications for florbetapir F 18 PET areexclusionary.