A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects With Early Alzheimer's Disease
Status: | Active, not recruiting |
---|---|
Conditions: | Alzheimer Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 55 - 85 |
Updated: | 3/30/2019 |
Start Date: | October 17, 2016 |
End Date: | July 31, 2021 |
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.
Alzheimer's Disease.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Subject has any contraindications or inability to tolerate 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.
We found this trial at
39
sites
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1211 Medical Center Drive
Nashville, Tennessee 37212
Nashville, Tennessee 37212
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