This is a long term extension study to evaluate safety and tolerability of subjects who complete study M11-793 which is evaluating a new treatment for subjects with mild to moderate Alzheimer's disease on stable doses of acetylcholinesterase inhibitors.
This is a Phase 2, open-label, multicenter, 28 week extension study to evaluate the long-term safety and tolerability of ABT-126 in subjects who complete dosing through Week 24 of Study M11-793. Up to 420 subjects may participate at approximately 40 sites in seven countries.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
343
See arm description
Adverse Events
Monitor each subject for clinical and laboratory evidence of adverse events on a routine basis throughout the study
Time frame: Assessments up through 28 weeks
Laboratory Data
Assessments include hematology, clinical chemistry, urinalysis and urine drug/alcohol screens
Time frame: Assessments up through 28 weeks
Vital Signs
Assessments include pulse, blood pressure and oral body temperature
Time frame: Assessments up through 28 weeks
Physical examinations
An examination of bodily functions and physical condition
Time frame: Assessments up through 28 weeks
Brief Neurological examination
Assessments include cranial nerves, motor and sensory system, reflexes, coordination, gait and station
Time frame: Assessments up through 28 weeks
Brief Psychiatric assessments
Assessments include mood, anxiety, psychosis or delusions, agitation, homicidal thoughts or behaviors
Time frame: Assessments up through 28 weeks
Columbia-Suicide Severity Rating Scale
The scale is designed to assess suicidal behavior and ideation
Time frame: Assessments up through 28 weeks
Cornell Scale for Depression in Dementia
Assesses the signs and symptoms of major depression in patients with dementia
Time frame: Assessments up through 28 weeks
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Site Reference ID/Investigator# 84185
Long Beach, California, United States
Site Reference ID/Investigator# 84183
San Francisco, California, United States
Site Reference ID/Investigator# 84187
Hamden, Connecticut, United States
Site Reference ID/Investigator# 84178
Delray Beach, Florida, United States
Site Reference ID/Investigator# 84180
Orlando, Florida, United States
Site Reference ID/Investigator# 84186
West Palm Beach, Florida, United States
Site Reference ID/Investigator# 84182
Elk Grove Village, Illinois, United States
Site Reference ID/Investigator# 84181
Staten Island, New York, United States
Site Reference ID/Investigator# 84179
Bennington, Vermont, United States
Site Reference ID/Investigator# 84173
Gatineau, Canada
...and 29 more locations
Electrocardiogram
Measurements include heart rate, RR interval, PR interval, QRS duration and QT intervals
Time frame: Assessments up through 28 weeks