This is an efficacy and safety study evaluating a new treatment for subjects with mild to moderate Alzheimer's disease.
This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in approximately 420 adults with mild to moderate Alzheimer's disease who are taking stable doses of acetylcholinesterase inhibitors. Subjects will be randomized to one of two ABT-126 dose arms or placebo for a 24-week treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
434
Alzheimer's Disease Assessment Scale - cognitive subscale
An assessment tool which focuses on cognitive function and memory
Time frame: Measurements up through 24 weeks
Mini Mental Status Exam
Questionnaire which provides a quantitative measure of cognition
Time frame: Measurements up through 24 weeks
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Caregiver-based assessment of activities of daily living
Time frame: Measurements up through 24 weeks
DEMentia Quality of Life (DEMQOL)
Health-related quality of life measurement tool
Time frame: Measurements up through 24 weeks
Clinician Interview-Based Impression of Change - plus (CIBIC-plus)
Measures a global impression of change in severity of dementia
Time frame: Measurements up through 24 weeks
Neuropsychiatry Inventory (NPI)
Assesses the presence of psychopathology in subjects with Alzheimer's disease and other dementias
Time frame: Measurements up through 24 weeks
Partner-Patient Questionnaire for Shared Activities (PPQSA)
Measures the extent to which mood and mental state interferes with the patient-partner relationship
Time frame: Measurements up through 24 weeks
Resource Use in Dementia (RUD-Lite)
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Site Reference ID/Investigator# 66528
Fresno, California, United States
Site Reference ID/Investigator# 69602
Long Beach, California, United States
Site Reference ID/Investigator# 66527
San Francisco, California, United States
Site Reference ID/Investigator# 66530
Hamden, Connecticut, United States
Site Reference ID/Investigator# 66522
Delray Beach, Florida, United States
Site Reference ID/Investigator# 66524
Orlando, Florida, United States
Site Reference ID/Investigator# 66531
Tampa, Florida, United States
Site Reference ID/Investigator# 66529
West Palm Beach, Florida, United States
Site Reference ID/Investigator# 66526
Elk Grove Village, Illinois, United States
Site Reference ID/Investigator# 66525
Staten Island, New York, United States
...and 33 more locations
Brief measurement tool for resource utilization
Time frame: Measurements up through 24 weeks
EuroQol-5D Questionnaires
Assesses patient's mobility, self-care, usual activity, pain/discomfort and anxiety/depression
Time frame: Measurements up through 24 weeks
Wechsler Memory Scale-III (WMS-III) Working Memory Index
Assesses working memory
Time frame: Measurements up through 18 weeks