Eli Lilly and Company
The main purpose of this study is to evaluate the long-term effectiveness of donanemab plus usual care versus usual care alone in participants with early symptomatic AD. The study will employ a prospective, observational cohort design with participant management resembling real-world practice to the greatest extent possible via prospective assessments and linkage to historical and prospective electronic health records. The study will last about 273 weeks and may include up to 28 visits.
Inclusion Criteria: Participants * are under care for presumed mild cognitive impairment (MCI) or mild dementia stage of AD (Note: neither a biomarker-based diagnosis of AD nor a diagnosis in electronic health records \[EHR\] is required prior to screening) * have a Telephone Interview for Cognitive Status (TICS) score of ≥21 * presence of amyloid beta (Aβ) pathology supported by biomarker results (e.g., P-tau, amyloid positron emission tomography (PET), and/or cerebrospinal fluid \[CSF\]). (Note: A historical biomarker may be used for eligibility if performed within 12 months of study entry…
Administered IV
Medication (excluding amyloid-targeting agents) or non-pharmacological therapy including watchful waiting.
Arctuva estimate
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