Trial · NCT03226522

Addressing Dementia Via Agitation-Centered Evaluation

NCT03226522, Phase 2, Phase 3, Completed, Axsome Therapeutics, Inc.; results first posted 2023-09-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Addressing Dementia Via Agitation-Centered Evaluation. Trials, record NCT03226522. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03226522

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Addressing Dementia Via Agitation-Centered Evaluation
NCT number: NCT03226522
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 366 participants, actual
Lead sponsor: Axsome Therapeutics, Inc.
Conditions: Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation,Psychomotor
Interventions: AXS-05, Bupropion, Placebo
First posted: 2017-07-21
Last updated: 2023-09-13
Results first posted: 2023-09-13

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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).

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in CMAI Total Score	5 weeks	modified Intent-to-Treat (mITT) Population	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in CMAI Total Score	AXS-05	-15.4	Standard Error 1.25	score on a scale
Change in CMAI Total Score	Bupropion	-10.0	Standard Error 3.02	score on a scale
Change in CMAI Total Score	Placebo	-11.5	Standard Error 1.10	score on a scale

Source ClinicalTrials.gov

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	AXS-05	159
Overall Study	STARTED	Bupropion	49
Overall Study	STARTED	Placebo	158
Overall Study	Safety Population	AXS-05	159
Overall Study	Safety Population	Bupropion	49
Overall Study	Safety Population	Placebo	158
Overall Study	mITT Population	AXS-05	152
Overall Study	mITT Population	Bupropion	49
Overall Study	mITT Population	Placebo	156
Overall Study	COMPLETED	AXS-05	137

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events69

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhea	Gastrointestinal disorders	AXS-05	7	159	9
other	Diarrhea	Gastrointestinal disorders	Bupropion	3	49	4
other	Diarrhea	Gastrointestinal disorders	Placebo	7	158	7
other	Fatigue	General disorders	AXS-05	3	159	3
other	Fatigue	General disorders	Bupropion	5	49	5
other	Fatigue	General disorders	Placebo	2	158	3
other	Fall	Injury, poisoning and procedural complications	AXS-05	4	159	13
other	Fall	Injury, poisoning and procedural complications	Bupropion	7	49	11
other	Fall	Injury, poisoning and procedural complications	Placebo	3	158	3
other	Dizziness	Nervous system disorders	AXS-05	10	159	11

1 to 10 of 69Source ClinicalTrials.gov

See all 69 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AXS-05	0	159
Total, all-cause mortality	Bupropion	1	49
Total, all-cause mortality	Placebo	1	158
Total, other adverse events	AXS-05	33	159
Total, other adverse events	Bupropion	17	49
Total, other adverse events	Placebo	24	158
Total, serious adverse events	AXS-05	5	159
Total, serious adverse events	Bupropion	4	49
Total, serious adverse events	Placebo	9	158

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03226522

GET https://conductscience.org/api/trials/v1/NCT03226522/events?page=2

API reference For AI assistants