Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation (NCT NCT05557409)
NCT ID: NCT05557409
Last Updated: 2026-08-13
Results Overview
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).
COMPLETED
PHASE3
408 participants
Up to 5 weeks
2026-08-13
Participant Flow
Participant milestones
| Measure |
AXS-05
Up to 5 weeks
AXS-05: AXS-05 tablets, taken twice daily
|
Placebo
Up to 5 weeks
Placebo: Placebo tablets, taken twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
204
|
204
|
|
Overall Study
COMPLETED
|
194
|
194
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation
Baseline characteristics by cohort
| Measure |
AXS-05
n=204 Participants
Up to 5 weeks
AXS-05: AXS-05 tablets, taken twice daily
|
Placebo
n=204 Participants
Up to 5 weeks
Placebo: Placebo tablets, taken twice daily
|
Total
n=408 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.6 years
STANDARD_DEVIATION 5.34 • n=1 Participants
|
75.0 years
STANDARD_DEVIATION 5.74 • n=1 Participants
|
74.3 years
STANDARD_DEVIATION 5.58 • n=1 Participants
|
|
Sex: Female, Male
Female
|
130 Participants
n=1 Participants
|
112 Participants
n=1 Participants
|
242 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=1 Participants
|
92 Participants
n=1 Participants
|
166 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
18 participants
n=1 Participants
|
23 participants
n=1 Participants
|
41 participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=1 Participants
|
2 participants
n=1 Participants
|
4 participants
n=1 Participants
|
|
Race/Ethnicity, Customized
White
|
184 participants
n=1 Participants
|
178 participants
n=1 Participants
|
362 participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=1 Participants
|
1 participants
n=1 Participants
|
1 participants
n=1 Participants
|
PRIMARY outcome
Timeframe: Up to 5 weeksThe 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).
Outcome measures
| Measure |
AXS-05
n=204 Participants
Up to 5 weeks
AXS-05: AXS-05 tablets, taken twice daily
|
Placebo
n=204 Participants
Up to 5 weeks
Placebo: Placebo tablets, taken twice daily
|
|---|---|---|
|
Cohen-Mansfield Agitation Inventory (CMAI)
|
-13.85 score on a scale
Standard Error 0.917
|
-12.77 score on a scale
Standard Error 0.921
|
Adverse Events
AXS-05
Placebo
Serious adverse events
| Measure |
AXS-05
n=204 participants at risk
Up to 5 weeks
AXS-05: AXS-05 tablets, taken twice daily
|
Placebo
n=204 participants at risk
Up to 5 weeks
Placebo: Placebo tablets, taken twice daily
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.49%
1/204 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected after administration of study drug through 7 days after the last dose (up to 5 weeks).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected after administration of study drug through 7 days after the last dose (up to 5 weeks).
|
|
General disorders
Asthenia
|
0.49%
1/204 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected after administration of study drug through 7 days after the last dose (up to 5 weeks).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected after administration of study drug through 7 days after the last dose (up to 5 weeks).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.49%
1/204 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected after administration of study drug through 7 days after the last dose (up to 5 weeks).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected after administration of study drug through 7 days after the last dose (up to 5 weeks).
|
Other adverse events
| Measure |
AXS-05
n=204 participants at risk
Up to 5 weeks
AXS-05: AXS-05 tablets, taken twice daily
|
Placebo
n=204 participants at risk
Up to 5 weeks
Placebo: Placebo tablets, taken twice daily
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
5.9%
12/204 • Number of events 14 • Treatment emergent adverse events (TEAEs) were collected after administration of study drug through 7 days after the last dose (up to 5 weeks).
|
1.5%
3/204 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected after administration of study drug through 7 days after the last dose (up to 5 weeks).
|
|
Nervous system disorders
Headache
|
4.4%
9/204 • Number of events 9 • Treatment emergent adverse events (TEAEs) were collected after administration of study drug through 7 days after the last dose (up to 5 weeks).
|
3.4%
7/204 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected after administration of study drug through 7 days after the last dose (up to 5 weeks).
|
|
Nervous system disorders
Somnolence
|
2.9%
6/204 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected after administration of study drug through 7 days after the last dose (up to 5 weeks).
|
2.5%
5/204 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected after administration of study drug through 7 days after the last dose (up to 5 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place