Addressing Dementia Via Agitation-Centered Evaluation

• AXS-05 (Drug): AXS-05
• Bupropion (Drug): Bupropion
• Placebo (Drug): Placebo

Primary outcomes

• Change in CMAI Total Score [5 weeks]: 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).

Sex: All, ages: 65 Years to 90 Years

Key Inclusion Criteria:

* Diagnosis of probable Alzheimer's disease (AD) based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria.
* Diagnosis of clinically signification agitation resulting from probable AD according to the International Psychogeriatric Association (IPA) provisional definition of agitation.

Exclusion Criteria:

* Patient has dementia predominantly of non-Alzheimer's type.
* Unable to comply with study procedures.
* Medically inappropriate for study participation in the opinion of the investigator.

Participant flow

Outcome results

• Change in CMAI Total Score (Primary), Mean, score on a scale: AXS-05 -15.4 +/- 1.25; Bupropion -10.0 +/- 3.02; Placebo -11.5 +/- 1.10 (p 0.010)

Adverse events

Time frame: Adverse events were collected from the Baseline visit through 30 days after the last study visit (up to 10 weeks).

Serious adverse events by term

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2020-03-16)