This is a multi-center, randomized, double-blind, placebo-controlled study, to assess the efficacy and safety of AXS-05 in the treatment of agitation in patients with Alzheimer's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
366
Change in CMAI Total Score
The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item caregiver-rated questionnaire that assesses the frequency of agitation-related and disruptive behaviors in subjects with dementia. The scale contains 29 behaviors or items organized into four subscales: physically aggressive, physically non-aggressive, verbally aggressive, and verbally non-aggressive. The CMAI is administered by interviewing the caregiver and asking him or her to rate the frequency with which the subject manifests each behavior using a seven-point scale: 1=never (better outcome), 7=several times an hour (worse outcome). The CMAI total score is the sum of the scores for all of the items in the CMAI. CMAI total scores range from a minimum of 29 (better outcome) to a maximum of 203 (worse outcome).
Time frame: 5 weeks
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Axsome Study Site
Gilbert, Arizona, United States
Axsome Study Site
Phoenix, Arizona, United States
Axsome study site
Scottsdale, Arizona, United States
Axsome study site
Scottsdale, Arizona, United States
Axsome Study Site
Tucson, Arizona, United States
Axsome Study Site
Little Rock, Arkansas, United States
Axsome study site
Canoga Park, California, United States
Axsome study site
Costa Mesa, California, United States
Axsome study site
Fresno, California, United States
Axsome study site
Long Beach, California, United States
...and 68 more locations