JPRN-jRCT2080223496CompletedPhase 3
A Placebo-Controlled, Double-Blind, Parallel-Group, 24 Month Study to Evaluate the Efficacy and Safety of E2609 in Subjects with Early Alzheimer's Disease
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 2,212
Study Overview
Brief Summary
This study was terminated early due to an unfavorable risk-benefit ratio including no evidence of potential efficacy and the adverse event profile in subjects with drug treatment was worse than that in subjects who received placebo. The small sample size at the 24 month time point of the Core Study limits the interpretability of the data.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 50age old to <= 85age old (—)
- Sex
- All
Inclusion Criteria
- •(1)Mild cognitive impairment due to AD or mild AD dementia
- •(2)Positive biomarker for brain amyloid pathology
- •(3)Study partner able to support the participant for duration of the study
Exclusion Criteria
- •(1)Any condition that may be contributing to cognitive impairment above and beyond that caused by the participant's AD
- •(2)Participants with a history of seizures within 5 years of Screening
- •(3)History of transient ischemic attacks or stroke within 12 months of Screening
- •(4)Psychiatric diagnosis or symptoms (e.g., hallucinations, major depression, delusions, etc.)
- •(5)Suicidal ideation or any suicidal behavior within 6 months before Screening or has been hospitalized or treated for suicidal behavior in the past 5 years
- •(6)Have any contraindications to magnetic resonance imaging (MRI) scanning
- •(7)Have lesions that could indicate a dementia diagnosis other than AD on brain MRI
- •(8)Exhibit other significant pathological findings on brain MRI
- •(9)Severe visual or hearing impairment
- •(10)Malignant neoplasms within 5 years of Screening
- •(11)Known or suspected history of drug or alcohol abuse
- •(12)Taking prohibited medications
Investigators
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