A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease
A Phase 2, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Finding Study to Evaluate Safety, Tolerability, and Biomarker Efficacy of E2814 With Concurrent Lecanemab Treatment in Subjects With Early Alzheimer's Disease
Sponsor: Eisai Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Change From Baseline in CSF MTBR-tau-243 at 6 Months
Time frame: Baseline at 6 months
Secondary Endpoints
Change From Baseline in Tau Positron Emission Tomography (PET) up to 24 Months
Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) up to 24 Months
Change From Baseline in Alzheimers Disease Cooperative Scale-Activities of Daily Living Mild Cognitive Impairment Version (ADCS MCI-ADL) up to 24 Months
Eligibility Criteria
Inclusion Criteria: 1. For participants diagnosed with mild cognitive impairment (MCI) due to AD-intermediate likelihood: 1. Meet the National Institute on Aging-Alzheimer's Association (NIA-AA) core clinical criteria for MCI due to AD-intermediate likelihood 2. Have a global Clinical Dementia Rating Scale (CDR) score of 0.5 and a CDR Memory Box score of greater than or equal to (\>=) 0.5 at Screening 2. For participants diagnosed with mild AD dementia: 1. Meet the NIA-AA core clinical criteria for probable AD dementia 2. Have a global CDR score of 0.5 to 1.0 and a CDR Memory Box score of \>=0.5 at Screening 3. Mini Mental State Examination (MMSE) score \>=22 at Screening and less than or equal to (\<=) 30 at Screening 4. Able to have CSF lumbar puncture performed and not on, or have a medical condition that may require initiation of, any anticoagulant therapy at Screening 5. Male or female participants aged between \>=50 years and \<=80 years, at the time of informed co…
Read full criteria on CT.gov →✦ Analyst Commentary
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