The goal of this clinical trial is to learn if the investigational drugs EXV-802 and EXV-801 can safely and effectively reduce agitation in participants with Alzheimer's Disease Dementia. Researchers will compare EXV-802 and EXV-801 with a placebo to see if EXV-802 and/or EXV-801 reduces agitation more effectively than the placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
Changes from baseline to endpoint (Week 6) in the Cohen-Mansfield Agitation Inventory (CMAI) score (range 1 - 7 per item; higher scores indicate more severe agitation)
Time frame: At Week 6
Changes from baseline to endpoint (Week 6) in the Clinical Global Impression - Severity (CGI-S) scale score (range 1 - 7; higher scores indicate worse disease severity)
Time frame: At Week 6
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