Addressing Dementia Via Agitation-Centered Evaluation | NCT03226522

Status Module

Label	Type	Description	Intervention Names
AXS-05	Experimental	AXS-05 tablets taken by mouth for 5 weeks.	Drug: AXS-05
Bupropion	Active Comparator	Bupropion tablets taken by mouth for 5 weeks.	Drug: Bupropion
Placebo	Placebo Comparator	Placebo tablets taken by mouth for 5 weeks.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
AXS-05	Drug	AXS-05	AXS-05
Bupropion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).	5 weeks

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Axsome Study Site		Gilbert	Arizona	85297	United States
Axsome Study Site

Label	URL
Axsome Therapeutics Website	View source

Results Section

Participant Flow Module

ID	Title	Description
FG000	AXS-05	AXS-05 tablets taken twice daily for 5 weeks. AXS-05: AXS-05
FG001	Bupropion	Bupropion tablets taken twice daily for 5 weeks. Bupropion: Bupropion

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 16, 2020

Arm/Group Information

ID	Title	Description
BG000	AXS-05	AXS-05 tablets taken by mouth for 5 weeks. AXS-05: AXS-05
BG001	Bupropion	Bupropion tablets taken by mouth for 5 weeks. Bupropion: Bupropion
BG002	Placebo	Placebo tablets taken by mouth for 5 weeks. Placebo: Placebo
BG003	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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).

modified Intent-to-Treat (mITT) Population

Posted

Mean

Standard Error

score on a scale

5 weeks

ID	Title	Description
OG000	AXS-05	AXS-05 tablets taken twice daily for 5 weeks. AXS-05: AXS-05
OG001	Bupropion	Bupropion tablets taken twice daily for 5 weeks. Bupropion: Bupropion
OG002	Placebo	Placebo tablets taken twice daily for 5 weeks. Placebo: Placebo

Units	Counts
Participants	OG000152 OG00149 OG002156

Title

Denominators

Categories

Title	Measurements
	OG000-15.4± 1.25 OG001-10.0± 3.02 OG002-11.5± 1.10

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Mixed Models Analysis		0.010														Superiority
OG000 OG001		Mixed Models Analysis		<0.001

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	AXS-05	AXS-05 tablets taken twice daily for 5 weeks. AXS-05: AXS-05	0	159	5	159	33	159
EG001	Bupropion	Bupropion tablets taken twice daily for 5 weeks. Bupropion: Bupropion	1	49	4	49	17	49
EG002	Placebo	Placebo tablets taken twice daily for 5 weeks. Placebo: Placebo	1	158	9	158	24	158

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal discomfort	Gastrointestinal disorders	MedDRA Dictionary	Non-systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected49 at risk EG0020 events0 affected158 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Dictionary	Non-systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected49 at risk EG0020 events0 affected158 at risk
Oedema peripheral	General disorders	MedDRA Dictionary	Non-systematic Assessment	EG0000 events0 affected159 at risk EG0010 events0 affected49 at risk EG0021 events1 affected158 at risk
Staphylococcal infection	Infections and infestations	MedDRA Dictionary	Non-systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected49 at risk EG0020 events0 affected158 at risk
Urinary tract infection	Infections and infestations	MedDRA Dictionary	Non-systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected49 at risk EG0021 events1 affected158 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Dictionary	Non-systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected49 at risk EG0020 events0 affected158 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA Dictionary	Non-systematic Assessment	EG0000 events0 affected159 at risk EG0010 events0 affected49 at risk EG0021 events1 affected158 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Dictionary	Non-systematic Assessment	EG0000 events0 affected159 at risk EG0010 events0 affected49 at risk EG0021 events1 affected158 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Dictionary	Non-systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected49 at risk EG0020 events0 affected158 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Dictionary	Non-systematic Assessment	EG0000 events0 affected159 at risk EG0010 events0 affected49 at risk EG0021 events1 affected158 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Dictionary	Non-systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected49 at risk EG0020 events0 affected158 at risk
Dementia	Nervous system disorders	MedDRA Dictionary	Non-systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected49 at risk EG0020 events0 affected158 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA Dictionary	Non-systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected49 at risk EG0021 events1 affected158 at risk
Syncope	Nervous system disorders	MedDRA Dictionary	Non-systematic Assessment	EG0000 events0 affected159 at risk EG0010 events0 affected49 at risk EG0021 events1 affected158 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA Dictionary	Non-systematic Assessment	EG0000 events0 affected159 at risk EG0010 events0 affected49 at risk EG0021 events1 affected158 at risk
Delirium	Psychiatric disorders	MedDRA Dictionary	Non-systematic Assessment	EG0000 events0 affected159 at risk EG0010 events0 affected49 at risk EG0021 events1 affected158 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhea	Gastrointestinal disorders	MedDRA Dictionary	Non-systematic Assessment	EG0009 events7 affected159 at risk EG0014 events3 affected49 at risk EG0027 events7 affected158 at risk
Fatigue	General disorders	MedDRA Dictionary	Non-systematic Assessment	EG0003 events3 affected159 at risk EG0015 events5 affected49 at risk EG0023 events2 affected158 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Dictionary	Non-systematic Assessment	EG00013 events4 affected159 at risk EG00111 events7 affected49 at risk EG0023 events3 affected158 at risk
Dizziness	Nervous system disorders	MedDRA Dictionary	Non-systematic Assessment	EG00011 events10 affected159 at risk EG0015 events5 affected49 at risk EG0025 events5 affected158 at risk
Headache	Nervous system disorders	MedDRA Dictionary	Non-systematic Assessment	EG0008 events6 affected159 at risk EG0013 events3 affected49 at risk EG0025 events4 affected158 at risk
Somnolence	Nervous system disorders	MedDRA Dictionary	Non-systematic Assessment	EG00013 events13 affected159 at risk EG0012 events2 affected49 at risk EG0025 events5 affected158 at risk
Insomnia	Psychiatric disorders	MedDRA Dictionary	Non-systematic Assessment	EG0002 events1 affected159 at risk EG0013 events3 affected49 at risk EG0024 events3 affected158 at risk

ID	Term
D000544	Alzheimer Disease
D011595	Psychomotor Agitation

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies
D019636	Neurodegenerative Diseases
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D020820	Dyskinesias
D009461	Neurologic Manifestations
D011596	Psychomotor Disorders
D019954	Neurobehavioral Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D000096762	Aberrant Motor Behavior in Dementia
D001526	Behavioral Symptoms
D001519	Behavior

ID	Term
D011427	Propiophenones
D007659	Ketones
D009930	Organic Chemicals