A Phase 3 interventional study of AXS-05 and Placebo in Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease and Agitation, sponsored by Axsome Therapeutics, Inc.. Completed at 55 sites in 2 countries. Open to participants aged 65 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Axsome Therapeutics, Inc. · Phase 3, Interventional, and Treatment
This trial was a multi-center, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of AXS-05 compared to placebo for the treatment of agitation associated with Alzheimer's disease.
Eligible subjects were randomized in a 1:1 ratio for up to 5 weeks to be treated with AXS-05 or placebo.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 408 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Axsome Therapeutics, Inc. is the lead sponsor of 36 studies on the registry; 12 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 11 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Up to 5 weeks
Drug: AXS-05
Up to 5 weeks
Drug: Placebo
AXS-05 tablets, taken twice daily
Placebo tablets, taken twice daily
Cohen-Mansfield Agitation Inventory (CMAI)
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: Up to 5 weeks
| Milestone | AXS-05 | Placebo |
|---|---|---|
| Started | 204 | 204 |
| Completed | 194 | 194 |
| Not completed | 10 | 10 |
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).
| score on a scale | AXS-05 | Placebo |
|---|---|---|
| Cohen-Mansfield Agitation Inventory (CMAI) | -13.85 ± 0.917 | -12.77 ± 0.921 |
Collected over Treatment emergent adverse events (TEAEs) were collected after administration of study drug through 7 days after the last dose (up to 5 weeks).. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AXS-05 | 0/204 (0%) | 2/204 (1%) | 27/204 (13.2%) |
| Placebo | 0/204 (0%) | 0/204 (0%) | 15/204 (7.4%) |
| Event | AXS-05 | Placebo |
|---|---|---|
| Urinary tract infectionInfections and infestations | 1/204 | 0/204 |
| AstheniaGeneral disorders | 1/204 | 0/204 |
| Cerebrovascular accidentNervous system disorders | 1/204 | 0/204 |
| Event | AXS-05 | Placebo |
|---|---|---|
| DizzinessNervous system disorders | 12/204 | 3/204 |
| HeadacheNervous system disorders | 9/204 | 7/204 |
| SomnolenceNervous system disorders | 6/204 | 5/204 |
| Age, Continuous(years) | AXS-05 | Placebo | Total |
|---|---|---|---|
| Mean | 73.6 ± 5.34 | 75.0 ± 5.74 | 74.3 ± 5.58 |
| Sex: Female, Male(Participants) | AXS-05 | Placebo | Total |
|---|---|---|---|
| Female | 130 | 112 | 242 |
| Male | 74 | 92 | 166 |
| Race/Ethnicity, Customized(participants) | AXS-05 | Placebo | Total |
|---|---|---|---|
| Black or African American | 18 | 23 | 41 |
| Asian | 2 | 2 | 4 |
| White | 184 | 178 | 362 |
| Other | 0 | 1 | 1 |
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Axsome Therapeutics, Inc.