ClinicaliQ Trial Snapshot
- A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer’s Disease (TRAILBLAZER-ALZ 5) — Recruiting • Phase III • Neurology • NCT05508789.
- The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks.
- Sponsor: Eli Lilly and Company.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks.
Eligibility Snapshot
- : * Gradual and progressive change in memory function reported by the participant or informant for ≥6 months. * A MMSE score of 20 to 28 (inclusive) at screening visit. * Meet amyloid scan (central read) criteria. * Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to the study or be available by telephone at designated times. * A second study partner may serve as backup. The study partner(s) is/are required to accompany the participant for signing consent. The study partner must be present on all days the cognitive and functional scales are administered. * If a participant has a second study partner, it is preferred that 1 study partner be primarily responsible for the CDR and the ADCS-ADL assessments. * Days requiring the following assessments and scales must have a study partner available by telephone if not accompanying participant for the following assessments * AEs and concomitant medications * CDR, and * ADCS-ADL * Stable concomitant symptomatic AD medications and other medications that may impact cognition for at least approximately 30 days prior to…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.