EUCTR2020-000077-25-NLRecruitingPhase 1
Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer’s Disease - TRAILBLAZER-ALZ 2
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Eli Lilly and Company
- Enrollment
- 1,736
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •-60 to 85 years of age inclusive, at the time of signing the informed consent,
- •-Gradual and progressive change in memory function reported by the participant or
- •informant for =6 months,
- •-An MMSE score of 20 to 28 (inclusive) at LEAD-IN SCREENING or COMPLETE SCREENING,
- •-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 study visits or be available by telephone at designated times
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1740
Exclusion Criteria
- •-Significant neurological disease affecting 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),
- •-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 <24months,
- •-History of cancer within the last 5 years, with the exception 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,
- •-Participants with any current primary psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessment, or affect the participant's ability to complete the study. Participants with history of schizophrenia or other chronic psychosis are excluded,
- •-History of clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity reactions (including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis,and/or exfoliative dermatitis),
Investigators
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