Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

  • STATUS
    Recruiting
  • End date
    Jun 11, 2027
  • participants needed
    1500
  • sponsor
    Eli Lilly and Company
Updated on 20 October 2022
mini-mental state examination
alzheimer's disease
florbetapir
flortaucipir

Summary

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.

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.

Details
Condition Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Neurocognitive Disorders, Mental Disorders
Treatment Placebo, Donanemab
Clinical Study IdentifierNCT05508789
SponsorEli Lilly and Company
Last Modified on20 October 2022

Eligibility

Yes No Not Sure

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

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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