This study will investigate safety, tolerability and pharmacokinetics of ABT-354 in up to 20 male and female subjects, between 55 to 90 years of age with mild to moderate Alzheimer's disease on stable doses of acetylcholinesterase inhibitors.
This is a double-blind, placebo-controlled, randomized, multiple-dose, multicenter study. Up to 20 male and female subjects with mild to moderate Alzheimer's disease (AD) who are taking stable doses of acetylcholinesterase inhibitors will be enrolled in this study. Within 28 days prior to study drug administration, subjects will be screened based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD, Mini-Mental State Examination (MMSE) and Modified Hachinski Ischemic Scale (MHIS) scores, medical history, physical examination, neurological examination, vital signs, ECG, laboratory tests and response to Columbia-Suicide Severity Rating Scale (C-SSRS). The study will be performed in two groups of 10 subjects each. In each group of 10 subjects, 7 subjects will be randomly assigned to receive ABT-354 and 3 subjects to receive matching placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Site Reference ID/Investigator# 106999
Miami, Florida, United States
Site Reference ID/Investigator# 106998
Orlando, Florida, United States
Site Reference ID/Investigator# 107000
Overland Park, Kansas, United States
Vital signs
Time frame: Up to Day 10
ECG (electrocardiogram)
Time frame: Up to Day 10
Neurological exam
Time frame: Up to Day 10
Laboratory tests
Hematology, Chemistry, Urinalysis
Time frame: Up to Day 10
Number of subject with adverse events
Time frame: Up to Day 10
C-SSRS (Columbia-Suicide Severity Rating Scale)
Time frame: Up to Day 10
Pharmacokinetic parameters
Cmax, Cmin, Tmax, AUC, t-1/2, CL/F
Time frame: Up to Day 10
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