Research Study Summary
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
This study seeks to evaluate the efficacy and safety of ABBV-8E12 in subjects with Early Alzheimer's Disease.
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CW ID: 222939
Date Last Changed:
February 6, 2017
Clinical Trial Snapshot
- Both Male and Female
- 55 to 85 Years
- Overall Status
- Facility Type
- 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.
- 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.
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