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

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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.


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
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La Jolla, California 92037
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Alexandria, Virginia 22310
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Atlanta, Georgia 30322
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Baltimore, Maryland 21224
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Boston, Massachusetts 02114
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Boston, Massachusetts 02115
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Chicago, Illinois 60640
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Dallas, TX
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Darlinghurst, New South Wales
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2665 North Decatur Road
Decatur, Georgia 30033
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Delray Beach, Florida 33445
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Durham, North Carolina 27710
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Durham, NC
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Fairway, KS
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Fort Myers, Florida 33912
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Hattiesburg, Mississippi 39401
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Houston, TX
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Indianapolis, Indiana 46202
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Irvine, California 92614
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Jacksonville, Florida 32224
1013
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232-01 Merrick Boulevard
Laurelton, New York 11413
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Lexington, KY
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1211 Medical Center Drive
Nashville, Tennessee 37212
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New Hyde Park, New York 11040
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Norristown, Pennsylvania 19403
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Orlando, Florida 32806
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Park Ridge, Illinois 60068
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Phoenix, AZ
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Portland, OR
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Princeton, New Jersey 08540
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593 Eddy Street
Providence, Rhode Island 02903
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Salt Lake City, Utah 84108
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San Francisco, California 94113
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San Francisco, California 94143
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Springfield, Illinois 62702
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Sun City, Arizona 85351
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4202 East Fowler Avenue
Tampa, Florida 33613
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The Villages, Florida 32162
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The Villages, FL
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