A Phase 2 Multiple Dose, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects with Early Alzheimer's Disease - M15-566

AbbVie B.V.0 个研究点目标入组 7 人开始时间: 待定最近更新: 2024年2月28日

研究概览

暂无简介。

•* Subject who meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) clinical criteria for mild cognitive impairment or probable AD, and have:
•- Clinical Dementia Rating (CDR)-Global Score of 0.5
•- Mini-Mental State Examination (MMSE) score of 22 to 30, inclusive
•- Repeatable Battery for the Assessment of Neuropsychological Status-Delayed Memory Index (RBANS - DMI) score of 85 or lower
•* Subject has a positive amyloid Positron Emission Tomography (PET) scan.
•* Subject has a Modified Hachinski Ischemic Scale (MHIS) score of 4.
•* The subject has an identified, reliable, study partner (e.g., family member).
•* If using medications to treat symptoms related to AD, doses must be stable for at least 12 weeks prior to randomization.

•* Subject has any contraindications or inability to tolerate to brain magnetic resonance imaging (MRI), PET scans or lumbar puncture (optional).
•* Subject has evidence of any other clinically significant neurological disorder other than Early AD.
•* In the opinion of the investigator, the subject has any clinically significant or uncontrolled medical or psychiatric illness, or has had an infection requiring medical intervention in the past 30 days.
•* Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic attack or required intervention for any of these conditions within 6 months of screening Visit 1.

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