This study is being conducted to determine the safety and effect on cognitive function of the investigational medication, EVP-6124, in individuals with mild to moderate probable Alzheimer's disease.
This is a randomized, double-blind, placebo-controlled, parallel, 24-week, Phase 2 safety/efficacy study in which three dose levels of EVP-6124 or placebo will be evaluated. Eligible for enrollment will be patients who meet clinical criteria for mild to moderate probable Alzheimer's disease who are either receiving treatment with AChEI medication at a stable dose or who are not presently taking any AChEI or memantine co-medication. Patients will be randomized to one of the following groups: 0.3 mg, 1 mg or 2 mg or Placebo. Approximately 400 subjects will be randomized to the 4 treatment groups. Study drug will be supplied as capsules and will be orally administered once daily for a total of 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
409
Alzheimer's Disease Assessment Scale-Cognitive subscale-13 (ADAS-cog-13)
Time frame: Day -7, Baseline, 4, 12, 18, 23 Weeks
Alzheimer's Disease Assessment Scale-Cognitive subscale-11
Time frame: 4, 12, 18, 23 Weeks
Controlled Oral Word Association Test
Time frame: Day -7, Baseline, 4, 12, 18, 23 Weeks
Category Fluency Test
Time frame: Day -7, Baseline, 4, 12, 18, 23 Weeks
Clinical Dementia Rating Scale Sum of Boxes
Time frame: Day -7, Baseline, 4, 12, 18, 23 Weeks
Alzheimer's Disease Cooperative Study-Activities of Daily Living
Time frame: Baseline, 4, 12, 18, 23 Weeks
Neuropsychiatric Inventory
Time frame: Baseline, 12, 23 Weeks
Mini-Mental State Exam
Time frame: Day -7, Baseline, 4, 12, 18, 23 Weeks
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