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

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 454 人开始时间: 2017年7月3日最近更新: 2021年8月30日

研究概览

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•- 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.
•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 70
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 384

•- Subject has any contraindications or inability to tolerate to brain magnetic resonance imaging (MRI), PET scans or lumbar puncture.
•- 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.

发起方