A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
- 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 randomization.
EXCLUSION CRITERIA
Exclusion Criteria:
- Has significant neurological disease affect the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures).
- Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of <24 months.
- History of cancer within the last 5 years, except of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, nonprogressive prostate cancer, or other cancers with low risk of recurrence or spread.
- Contraindication to MRI or PET scans
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Alzheimer Disease,Dementia,Brain Diseases,Central Nervous System Diseases,Nervous System Diseases,Tauopathies,Neurodegenerative Diseases,Neurocognitive Disorders,Mental Disorders
Age
60+
Phase
PHASE3
Participants Needed
1500
Est. Completion Date
Apr 30, 2027
Treatment Type
INTERVENTIONAL
Sponsor
Eli Lilly and Company
ClinicalTrials.gov NCT Identifier
NCT05508789
Study Number
I5T-MC-AACO
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