Australian Alzheimer's Research Foundation | Clinical Trials Division
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About
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.
Full description
TRAILBLAZER-ALZ 5 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants with early symptomatic AD (prodromal AD and mild dementia due to AD) with the presence of brain tau pathology.
Enrollment
Sex
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Volunteers
Inclusion criteria
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 Day 601 or 1.
Meet flortaucipir F18 scan (central read) criteria
Meet florbetapir F18 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
Stable concomitant symptomatic AD medications and other medications that may impact cognition for at least approximately 30 days prior to randomization.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
1,500 participants in 2 patient groups, including a placebo group
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Central trial contact
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Data sourced from clinicaltrials.gov
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