CompletedPhase 3Results posted

Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type

A Multicenter, Randomized, Double-Blind, Placebo Controlled Flexible Dose Study of Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Asset

Aripiprazole

Listed sites

Recruiting sites

Enrollment

232

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 6-24•Study partner/caregiver required

Primary endpoint

•Neuropsychiatric Inventory (NPI)

Identifiers

Registered as

Org study IDCN138-006

NCT IDNCT01438060

Timeline

Milestones

Study start2000-08 (month precision)

Primary completion2010-07actual (month precision)

Study completion2010-07actual (month precision)

Study first posted2011-09-21estimated

Results first posted2012-03-05estimated

Last update posted2013-12-02estimated

Assets

Drug assets

Aripiprazole

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age95 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Non-institutionalized patients with a diagnosis of Alzheimer's disease as defined by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria with symptoms of delusions or hallucinations, which have been present, at least intermittently for one month or longer

•Mini Mental State Examination (MMSE) score of 6 to 24 points

•Patients capable of self locomotion or locomotion with the aid of an assistive device

•Patients with an identified caregiver or proxy

For Extension Phase:

Eligible patients were males and females who had completed the 10-week Acute Phase in either treatment group; had a Week 10 Total Score of ≥ 6 on the NPI; and were, in the judgment of the investigator, deemed suitable for participation in the long-term trial.

Treatment beyond 140 weeks:

All subjects who completed the extension phase of CN138-006 in any French Investigational Site may be considered eligible for entry until they are no longer receiving clinical benefit, per the investigator's judgment

Exclusion criteria

•Patients with an Axis I (DSM IV) diagnosis of:

-delirium

-amnestic disorders

-bipolar disorder

-schizophrenia or schizoaffective disorder

-mood disorder with psychotic features

•Patients with reversible causes of dementia

•Patients with psychotic symptoms continuously present since prior to the onset of the symptoms of dementia

•Patients with psychotic symptoms that are better accounted for by another general medical condition or by direct physiological effects of a substance

•Patients with a current major depressive episode with psychotic symptoms of hallucinations or delusions

•Patients with a diagnosis of dementia related to infection with the human immunodeficiency virus

•Patients with substance-induced persistent dementia

•Patients with dementia due to vascular causes, multi-infarct, head trauma, Pick's disease, Parkinson's disease, frontal or temporal dementia, Lewy body dementia, or any specific non-Alzheimer's type dementia

•Patients with seizure disorders

•Patients who have been refractory to neuroleptics used to treat psychotic symptoms in the past when treated for an adequate period with a therapeutic dose, unless permission is obtained from Bristol-Myers Squibb

•Patients who have met DSM-IV criteria for any significant substance use disorder within the 6 months prior to the start of screening

Endpoints (84)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric

Safety / tolerability / PK

Other (unclassified)

Other clinical outcomes

Global cognition

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Mini Mental State Examination (MMSE) Total Score in Acute Phase

Time frame:Baseline (Day 0), Week 10

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Mini Mental State Examination (MMSE) Total Score in Acute Phase

Time frame:Baseline (Day 0), Week 10

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), Units on Scale	Standard error
PlaceboBaseline (Day 0); N=86,94n=100 Participants	14.13	0.60
Week 10; n=82, 87n=100 Participants	0.53	0.37
AripiprazoleBaseline (Day 0); N=86,94n=103 Participants	14.35	0.58
Week 10; n=82, 87n=103 Participants	-0.81	0.36

Mean Difference (Final Values)0.2395% CI-1.08 - 1.54p0.733ANCOVA

Analysis at baseline

Mean Difference (Final Values)-1.3595% CI-2.16 - -0.54p0.001ANOVA

Analysis at Week 10

Behavior / neuropsychiatric

42 endpoints

Primary/protocol endpoint

Change From Baseline in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 10 in Acute Phase

Time frame:Baseline (Day 0), Week 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Primary/registry result

Change From Baseline in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 10 in Acute Phase

Time frame:Baseline (Day 0), Week 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale	Standard error
PlaceboBaseline (Day 0)n=100 Participants	12.12	0.60
Mean Change from Baseline at Week 10n=100 Participants	-5.52	0.66
AripiprazoleBaseline (Day 0)n=103 Participants	12.29	0.59
Mean Change from Baseline at Week 10n=103 Participants	-6.55	0.65

Mean Difference (Final Values)0.1795% CI-1.15 - 1.49p0.802ANOVA

Analysis at Baseline (Day 0)

Mean Difference (Final Values)-1.0295% CI-2.49 - 0.44p0.169ANCOVA

Analysis at Week 10

Secondary/protocol endpoint

Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, and 8

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in NPI Total Score in Acute Phase

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Participants Who Demonstrated a ≥ 50% Decrease From Baseline to Endpoint in the NPI Psychosis Subscale Score in Acute Phase

Time frame:Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

event count, event

Secondary/protocol endpoint

Participants Who Demonstrated a ≥ 50% Decrease From Baseline in the Total NPI Score in Acute Phase

Time frame:Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

event count, event

Secondary/protocol endpoint

Change From Baseline in NPI Psychosis Subscale Caregiver Distress Score in Acute Phase

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in NPI Total Caregiver Distress Score in Acute Phase

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score in Acute Phase

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in NPI Individual Item Scores in Acute Phase: Delusions

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in NPI Individual Item Scores in Acute Phase: Hallucinations

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in NPI Individual Item Scores in Acute Phase: Agitation/Aggression

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in NPI Individual Item Scores in Acute Phase: Depression/Dysphoria

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in NPI Individual Item Scores in Acute Phase: Anxiety

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in NPI Individual Item Scores in Acute Phase: Apathy/Indifference

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in NPI Individual Item Scores in Acute Phase: Elation/Euphoria

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in NPI Individual Item Scores in Acute Phase: Disinhibition

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in NPI Individual Item Scores in Acute Phase: Irritability/Lability

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in NPI Individual Item Scores in Acute Phase: Aberrant Motor Behavior

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in NPI Individual Item Scores in Acute Phase: Appetite/Eating Behaviors

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in NPI Individual Item Scores in Acute Phase: Sleep

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score From Baseline During Extension Phase

Time frame:Baseline (Day 0), Weeks 18,26,40,52,68,84,100,116,132,140

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, and 8

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Units on Scale	Reported spread / bounds
PlaceboBaseline (Day 0)n=100 Participants	12.12	0.6010.95 - 13.30
Week 1n=100 Participants	-3.33	0.53-4.37 - -2.28
Week 2n=100 Participants	-3.96	0.67-5.27 - -2.65
Week 3n=100 Participants	-4.54	0.64-5.80 - -3.28
Week 4n=100 Participants	-5.38	0.61-6.59 - -4.18
Week 6n=100 Participants	-4.87	0.64-6.13 - -3.61
Week 8n=100 Participants	-5.04	0.69-6.40 - -3.69
AripiprazoleBaseline (Day 0)n=103 Participants	12.29	0.5911.12 - 13.46
Week 1n=103 Participants	-2.26	0.52-3.29 - -1.22
Week 2n=103 Participants	-3.81	0.66-5.11 - -2.50
Week 3n=103 Participants	-4.86	0.64-6.12 - -3.61
Week 4n=103 Participants	-5.66	0.61-6.86 - -4.47
Week 6n=103 Participants	-6.00	0.63-7.25 - -4.75
Week 8n=103 Participants	-6.01	0.68-7.36 - -4.67

Secondary/registry result

Change From Baseline in NPI Total Score in Acute Phase

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a Scale	Reported spread / bounds
PlaceboBaseline (Day 0)n=100 Participants	40.08	1.8836.38 - 43.78
Week 1n=100 Participants	-6.26	1.58-9.39 - -3.13
Week 2n=100 Participants	-9.98	1.86-13.65 - -6.32
Week 3n=100 Participants	-10.85	2.13-15.04 - -6.65
Week 4n=100 Participants	-11.81	1.87-15.50 - -8.12
Week 6n=100 Participants	-10.47	2.09-14.59 - -6.35
Week 8n=100 Participants	-9.68	2.32-14.26 - -5.09
Week 10n=100 Participants	-9.75	2.35-14.40 - -5.11
AripiprazoleBaseline (Day 0)n=103 Participants	39.82	1.8636.14 - 43.49
Week 1n=103 Participants	-4.13	1.57-7.23 - -1.03
Week 2n=103 Participants	-8.40	1.84-12.04 - -4.77
Week 3n=103 Participants	-8.61	2.11-12.77 - -4.45
Week 4n=103 Participants	-11.74	1.86-15.40 - -8.08
Week 6n=103 Participants	-11.61	2.07-15.69 - -7.52
Week 8n=103 Participants	-10.71	2.30-15.26 - -6.17
Week 10n=103 Participants	-11.20	2.33-15.80 - -6.59

Secondary/registry result

Participants Who Demonstrated a ≥ 50% Decrease From Baseline to Endpoint in the NPI Psychosis Subscale Score in Acute Phase

Time frame:Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
PlaceboWeek 1n=100 Participants	24	-
Week 2n=100 Participants	37	-
Week 3n=100 Participants	45	-
Week 4n=100 Participants	52	-
Week 6n=100 Participants	53	-
Week 8n=100 Participants	58	-
Week 10n=100 Participants	60	-
AripiprazoleWeek 1n=103 Participants	18	-
Week 2n=103 Participants	34	-
Week 3n=103 Participants	44	-
Week 4n=103 Participants	47	-
Week 6n=103 Participants	56	-
Week 8n=103 Participants	64	-
Week 10n=103 Participants	70	-

Response ratio0.7995% CI0.47 - 1.35p0.391Cochran-Mantel-Haenszel

Analysis at Week 1

Response ratio0.9595% CI0.69 - 1.31p0.766Cochran-Mantel-Haenszel

Analysis at Week 2

Response ratio1.0195% CI0.76 - 1.32p0.967Cochran-Mantel-Haenszel

Analysis at Week 3

Response ratio0.9295% CI0.71 - 1.19p0.505Cochran-Mantel-Haenszel

Analysis at Week 4

Response ratio1.0795% CI0.84 - 1.36p0.590Cochran-Mantel-Haenszel

Analysis at Week 6

Response ratio1.1095% CI0.89 - 1.37p0.374Cochran-Mantel-Haenszel

Analysis at Week 8

Response ratio1.1595% CI0.94 - 1.41p0.175Cochran-Mantel-Haenszel

Analysis at Week 10

Secondary/registry result

Participants Who Demonstrated a ≥ 50% Decrease From Baseline in the Total NPI Score in Acute Phase

Time frame:Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
PlaceboWeek 1n=100 Participants	12	-
Week 2n=100 Participants	31	-
Week 3n=100 Participants	35	-
Week 4n=100 Participants	44	-
Week 6n=100 Participants	45	-
Week 8n=100 Participants	52	-
Week 10n=100 Participants	47	-
AripiprazoleWeek 1n=103 Participants	11	-
Week 2n=103 Participants	29	-
Week 3n=103 Participants	33	-
Week 4n=103 Participants	37	-
Week 6n=103 Participants	45	-
Week 8n=103 Participants	50	-
Week 10n=103 Participants	53	-

Response ratio0.8895% CI0.41 - 1.92p0.753Cochran-Mantel-Haenszel

Analysis at week 1

Response ratio0.9095% CI0.62 - 1.32p0.600Cochran-Mantel-Haenszel

Analysis at week 2

Response ratio0.9395% CI0.65 - 1.31p0.673Cochran-Mantel-Haenszel

Analysis at week 3

Response ratio0.8395% CI0.60 - 1.14p0.255Cochran-Mantel-Haenszel

Analysis at week 4

Response ratio0.9995% CI0.74 - 1.33p0.958Cochran-Mantel-Haenszel

Analysis at week 6

Response ratio0.9295% CI0.71 - 1.19p0.525Cochran-Mantel-Haenszel

Analysis at week 8

Response ratio1.0795% CI0.82 - 1.40p0.602Cochran-Mantel-Haenszel

Analysis at week 10

Secondary/registry result

Change From Baseline in NPI Psychosis Subscale Caregiver Distress Score in Acute Phase

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Unit on a Scale	Reported spread / bounds
PlaceboBaseline (Day 0)n=100 Participants	4.80	0.254.30 - 5.29
Week 1n=100 Participants	-0.80	0.21-1.21 - -0.38
Week 2n=100 Participants	-0.84	0.23-1.30 - -0.38
Week 3n=100 Participants	-1.15	0.24-1.62 - -0.69
Week 4n=100 Participants	-1.31	0.23-1.76 - -0.86
Week 6n=100 Participants	-1.36	0.27-1.89 - -0.84
Week 8n=100 Participants	-1.18	0.27-1.71 - -0.65
Week 10n=100 Participants	-1.35	0.26-1.86 - -0.83
AripiprazoleBaseline (Day 0)n=103 Participants	4.70	0.254.21 - 5.19
Week 1n=103 Participants	-0.64	0.21-1.05 - -0.24
Week 2n=103 Participants	-0.78	0.23-1.24 - -0.33
Week 3n=103 Participants	-0.93	0.23-1.40 - -0.47
Week 4n=103 Participants	-1.28	0.23-1.73 - -0.84
Week 6n=103 Participants	-1.62	0.26-2.14 - -1.10
Week 8n=103 Participants	-1.65	0.27-2.17 - -1.12
Week 10n=103 Participants	-1.79	0.26-2.30 - -1.28

Secondary/registry result

Change From Baseline in NPI Total Caregiver Distress Score in Acute Phase

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a Scale	Reported spread / bounds
PlaceboBaseline (Day 0)n=100 Participants	16.58	0.8714.87 - 18.29
Week 1n=100 Participants	-1.81	0.65-3.08 - -0.53
Week 2n=100 Participants	-3.25	0.72-4.67 - -1.83
Week 3n=100 Participants	-4.10	0.81-5.76 - -2.44
Week 4n=100 Participants	-4.01	0.80-5.59 - -2.44
Week 6n=100 Participants	-3.58	0.98-5.51 - -1.66
Week 8n=100 Participants	-3.20	0.99-5.16 - -1.25
Week 10n=100 Participants	-3.15	1.03-5.19 - -1.11
AripiprazoleBaseline (Day 0)n=103 Participants	17.06	0.8615.37 - 18.76
Week 1n=103 Participants	-1.64	0.65-2.92 - -0.36
Week 2n=103 Participants	-3.04	0.72-4.47 - -1.61
Week 3n=103 Participants	-2.58	0.84-4.25 - -0.92
Week 4n=103 Participants	-3.48	0.80-5.06 - -1.90
Week 6n=103 Participants	-3.72	0.98-5.65 - -1.79
Week 8n=103 Participants	-3.46	0.99-5.42 - -1.50
Week 10n=103 Participants	-3.53	1.04-5.57 - -1.48

Secondary/registry result

Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score in Acute Phase

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

change from baseline, improvement

Posted result

Group	Value (mean), Unit on Scale	Reported spread / bounds
PlaceboBaseline (Day 0); n=95, 100n=100 Participants	43.42	1.3240.32 - 46.02
Week 2; n=87, 95n=100 Participants	-4.65	0.95-6.54 - -2.77
Week 4; n=95, 100n=100 Participants	-5.80	0.97-7.72 - -3.88
Week 6; n=95, 100n=100 Participants	-6.13	1.09-8.29 - -3.97
Week 8; n=95, 100n=100 Participants	-6.45	1.17-8.76 - -4.14
Week 10; n=95, 100n=100 Participants	-6.28	1.26-9.07 - -4.09
AripiprazoleBaseline (Day 0); n=95, 100n=103 Participants	43.63	1.2841.10 - 46.16
Week 2; n=87, 95n=103 Participants	-5.82	0.94-7.68 - -3.96
Week 4; n=95, 100n=103 Participants	-7.44	0.95-9.31 - -5.58
Week 6; n=95, 100n=103 Participants	-8.50	1.07-10.60 - -6.40
Week 8; n=95, 100n=103 Participants	-8.47	1.14-10.72 - -6.22
Week 10; n=95, 100n=103 Participants	-8.53	1.23-10.95 - -6.10

Secondary/registry result

Change From Baseline in NPI Individual Item Scores in Acute Phase: Delusions

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a Scale	Reported bounds
PlaceboBaseline (Day 0)n=100 Participants	7.85	-7.29 - 8.41
Week 1n=100 Participants	-2.37	--3.02 - -1.71
Week 2n=100 Participants	-2.84	--3.69 - -1.98
Week 3n=100 Participants	-3.25	--4.07 - -2.42
Week 4n=100 Participants	-3.72	--4.54 - -2.90
Week 6n=100 Participants	-3.45	--4.28 - -2.61
Week 8n=100 Participants	-3.52	--4.41 - -2.63
Week 10n=100 Participants	-3.94	--4.81 - -3.07
AripiprazoleBaseline (Day 0)n=103 Participants	8.11	-7.55 - 8.67
Week 1n=103 Participants	-1.61	--2.25 - -0.97
Week 2n=103 Participants	-2.72	--3.57 - -1.88
Week 3n=103 Participants	-3.50	--4.32 - -2.69
Week 4n=103 Participants	-3.89	--4.69 - -3.08
Week 6n=103 Participants	-3.95	--4.78 - -3.13
Week 8n=103 Participants	-3.91	--4.79 - -3.03
Week 10n=103 Participants	-4.28	--5.14 - -3.43

Secondary/registry result

Change From Baseline in NPI Individual Item Scores in Acute Phase: Hallucinations

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a Scale	Reported bounds
PlaceboBaseline (Day 0)n=100 Participants	4.27	-3.25 - 5.29
Week 1n=100 Participants	-0.98	--1.63 - -0.32
Week 2n=100 Participants	-1.15	--1.86 - -0.43
Week 3n=100 Participants	-1.34	--2.05 - -0.63
Week 4n=100 Participants	-1.71	--2.31 - -1.10
Week 6n=100 Participants	-1.43	--2.02 - -0.84
Week 8n=100 Participants	-1.57	--2.22 - -0.91
Week 10n=100 Participants	-1.65	--2.28 - -1.03
AripiprazoleBaseline (Day 0)n=103 Participants	4.18	-3.17 - 5.19
Week 1n=103 Participants	-0.65	--1.30 - 0.00
Week 2n=103 Participants	-1.09	--1.80 - -0.38
Week 3n=103 Participants	-1.37	--2.08 - -0.67
Week 4n=103 Participants	-1.79	--2.40 - -1.19
Week 6n=103 Participants	-2.03	--2.62 - -1.45
Week 8n=103 Participants	-2.12	--2.77 - -1.47
Week 10n=103 Participants	-2.30	--2.92 - -1.67

Secondary/registry result

Change From Baseline in NPI Individual Item Scores in Acute Phase: Agitation/Aggression

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a Scale	Reported bounds
PlaceboBaseline (Day 0)n=100 Participants	3.52	-2.68 - 4.37
Week 1n=100 Participants	-0.34	--1.12 - 0.43
Week 2n=100 Participants	-1.16	--1.86 - -0.47
Week 3n=100 Participants	-0.73	--1.50 - 0.03
Week 4n=100 Participants	-0.78	--1.51 - -0.05
Week 6n=100 Participants	-0.31	--1.08 - 0.46
Week 8n=100 Participants	-0.12	--0.94 - 0.69
Week 10n=100 Participants	-0.47	--1.32 - 0.37
AripiprazoleBaseline (Day 0)n=103 Participants	4.04	-3.20 - 4.87
Week 1n=103 Participants	0.10	--0.68 - 0.88
Week 2n=103 Participants	-0.69	--1.38 - 0.01
Week 3n=103 Participants	-0.59	--1.35 - 0.17
Week 4n=103 Participants	-1.38	--2.11 - -0.65
Week 6n=103 Participants	-0.94	--1.71 - -0.18
Week 8n=103 Participants	-0.84	--1.65 - -0.03
Week 10n=103 Participants	-1.12	--1.96 - -0.28

Secondary/registry result

Change From Baseline in NPI Individual Item Scores in Acute Phase: Depression/Dysphoria

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a Scale	Reported bounds
PlaceboBaseline (Day 0)n=100 Participants	3.27	-2.59 - 3.95
Week 1n=100 Participants	0.21	--0.39 - 0.81
Week 2n=100 Participants	-0.44	--1.01 - 0.13
Week 3n=100 Participants	-0.77	--1.28 - -0.25
Week 4n=100 Participants	-0.72	--1.22 - -0.22
Week 6n=100 Participants	-0.47	--1.04 - 0.10
Week 8n=100 Participants	-0.65	--1.20 - -0.11
Week 10n=100 Participants	-0.32	--0.95 - 0.32
AripiprazoleBaseline (Day 0)n=103 Participants	2.28	-1.60 - 2.95
Week 1n=103 Participants	-0.04	--0.62 - 0.54
Week 2n=103 Participants	-0.36	--0.91 - 0.19
Week 3n=103 Participants	-0.33	--0.84 - 0.17
Week 4n=103 Participants	-0.50	--0.99 - -0.02
Week 6n=103 Participants	-0.55	--1.10 - 0.00
Week 8n=103 Participants	-0.54	--1.07 - -0.01
Week 10n=103 Participants	-0.42	--1.04 - 0.19

Secondary/registry result

Change From Baseline in NPI Individual Item Scores in Acute Phase: Anxiety

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a Scale	Reported bounds
PlaceboBaseline (Day 0)n=100 Participants	3.64	-2.81 - 4.46
Week 1n=100 Participants	0.02	--0.73 - 0.77
Week 2n=100 Participants	-0.08	--0.73 - 0.58
Week 3n=100 Participants	-0.43	--1.14 - 0.29
Week 4n=100 Participants	-0.80	--1.47 - -0.14
Week 6n=100 Participants	-0.79	--1.49 - -0.08
Week 8n=100 Participants	-0.23	--0.90 - 0.44
Week 10n=100 Participants	-0.43	--1.13 - 0.26
AripiprazoleBaseline (Day 0)n=103 Participants	3.17	-2.36 - 3.99
Week 1n=103 Participants	0.05	--0.69 - 0.79
Week 2n=103 Participants	0.08	--0.56 - 0.72
Week 3n=103 Participants	0.07	--0.63 - 0.77
Week 4n=103 Participants	-0.38	--1.03 - 0.27
Week 6n=103 Participants	-0.13	--0.82 - 0.57
Week 8n=103 Participants	-0.21	--0.87 - 0.46
Week 10n=103 Participants	-0.31	--0.99 - 0.37

Secondary/registry result

Change From Baseline in NPI Individual Item Scores in Acute Phase: Apathy/Indifference

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a Scale	Reported bounds
PlaceboBaseline (Day 0)n=100 Participants	4.14	-3.41 - 4.86
Week 1n=100 Participants	0.03	--0.66 - 0.71
Week 2n=100 Participants	-0.48	--1.11 - 0.15
Week 3n=100 Participants	-0.09	--0.80 - 0.62
Week 4n=100 Participants	-0.65	--1.39 - 0.10
Week 6n=100 Participants	-0.63	--1.43 - 0.17
Week 8n=100 Participants	-0.87	--1.60 - -0.15
Week 10n=100 Participants	-0.95	--1.78 - -0.11
AripiprazoleBaseline (Day 0)n=103 Participants	3.47	-2.75 - 4.19
Week 1n=103 Participants	-0.70	--1.37 - -0.03
Week 2n=103 Participants	-0.76	--1.37 - -0.14
Week 3n=103 Participants	-0.36	--1.06 - 0.33
Week 4n=103 Participants	-0.67	--1.40 - 0.06
Week 6n=103 Participants	-0.40	--1.18 - 0.38
Week 8n=103 Participants	-0.21	--0.92 - 0.49
Week 10n=103 Participants	-0.09	--0.91 - 0.72

Secondary/registry result

Change From Baseline in NPI Individual Item Scores in Acute Phase: Elation/Euphoria

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a Scale	Reported bounds
PlaceboBaseline (Day 0)n=100 Participants	0.56	-0.06 - 1.05
Week 1n=100 Participants	-0.48	--0.75 - -0.22
Week 2n=100 Participants	-0.37	--0.63 - -0.11
Week 3n=100 Participants	-0.48	--0.76 - -0.20
Week 4n=100 Participants	-0.47	--0.66 - -0.28
Week 6n=100 Participants	-0.38	--0.58 - -0.18
Week 8n=100 Participants	-0.32	--0.59 - -0.04
Week 10n=100 Participants	-0.42	--0.65 - -0.19
AripiprazoleBaseline (Day 0)n=103 Participants	0.73	-0.24 - 1.23
Week 1n=103 Participants	-0.26	--0.52 - 0.01
Week 2n=103 Participants	-0.18	--0.43 - 0.08
Week 3n=103 Participants	-0.27	--0.54 - 0.01
Week 4n=103 Participants	-0.40	--0.59 - -0.21
Week 6n=103 Participants	-0.39	--0.59 - -0.20
Week 8n=103 Participants	-0.25	--0.52 - 0.03
Week 10n=103 Participants	-0.36	--0.59 - -0.14

Secondary/registry result

Change From Baseline in NPI Individual Item Scores in Acute Phase: Disinhibition

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a Scale	Reported bounds
PlaceboBaseline (Day 0)n=100 Participants	0.98	-0.39 - 1.57
Week 1n=100 Participants	-0.14	--0.54 - 0.25
Week 2n=100 Participants	-0.42	--0.91 - 0.07
Week 3n=100 Participants	-0.27	--0.86 - 0.32
Week 4n=100 Participants	-0.55	--1.04 - -0.06
Week 6n=100 Participants	-0.19	--0.64 - 0.26
Week 8n=100 Participants	-0.20	--0.67 - 0.28
Week 10n=100 Participants	0.07	--0.47 - 0.60
AripiprazoleBaseline (Day 0)n=103 Participants	1.36	-0.77 - 1.94
Week 1n=103 Participants	-0.39	--0.79 - 0.00
Week 2n=103 Participants	-0.44	--0.93 - 0.05
Week 3n=103 Participants	-0.21	--0.80 - 0.38
Week 4n=103 Participants	-0.67	--1.16 - -0.19
Week 6n=103 Participants	-0.72	--1.17 - -0.28
Week 8n=103 Participants	-0.44	--0.91 - 0.03
Week 10n=103 Participants	-0.35	--0.88 - 0.18

Secondary/registry result

Change From Baseline in NPI Individual Item Scores in Acute Phase: Irritability/Lability

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a Scale	Reported bounds
PlaceboBaseline (Day 0)n=100 Participants	3.73	-2.80 - 4.66
Week 1n=100 Participants	-0.73	--1.48 - 0.02
Week 2n=100 Participants	-0.89	--1.65 - -0.12
Week 3n=100 Participants	-1.11	--1.89 - -0.32
Week 4n=100 Participants	-0.75	--1.53 - 0.02
Week 6n=100 Participants	-0.42	--1.19 - 0.36
Week 8n=100 Participants	-0.33	--1.16 - 0.50
Week 10n=100 Participants	-0.24	--1.02 - 0.53
AripiprazoleBaseline (Day 0)n=103 Participants	4.36	-3.44 - 5.28
Week 1n=103 Participants	-0.09	--0.84 - 0.66
Week 2n=103 Participants	-0.69	--1.45 - 0.08
Week 3n=103 Participants	-1.09	--1.87 - -0.30
Week 4n=103 Participants	-1.53	--2.30 - -0.76
Week 6n=103 Participants	-1.29	--2.06 - -0.51
Week 8n=103 Participants	-0.99	--1.82 - -0.16
Week 10n=103 Participants	-1.26	--2.03 - -0.48

Secondary/registry result

Change From Baseline in NPI Individual Item Scores in Acute Phase: Aberrant Motor Behavior

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a Scale	Reported bounds
PlaceboBaseline (Day 0)n=100 Participants	3.67	-2.69 - 4.66
Week 1n=100 Participants	-0.66	--1.26 - -0.06
Week 2n=100 Participants	-0.84	--1.63 - -0.06
Week 3n=100 Participants	-1.68	--2.45 - -0.09
Week 4n=100 Participants	-0.91	--1.73 - -0.09
Week 6n=100 Participants	-0.89	--1.64 - -0.13
Week 8n=100 Participants	-1.06	--1.78 - -0.33
Week 10n=100 Participants	-1.02	--1.83 - -0.22
AripiprazoleBaseline (Day 0)n=103 Participants	3.61	-2.63 - 4.59
Week 1n=103 Participants	0.18	--0.42 - 0.77
Week 2n=103 Participants	-0.51	--1.29 - 0.27
Week 3n=103 Participants	-0.66	--1.43 - 0.12
Week 4n=103 Participants	-0.16	--0.98 - 0.65
Week 6n=103 Participants	-0.61	--1.36 - 0.14
Week 8n=103 Participants	-0.83	--1.55 - -0.11
Week 10n=103 Participants	-0.89	--1.69 - -0.09

Secondary/registry result

Change From Baseline in NPI Individual Item Scores in Acute Phase: Appetite/Eating Behaviors

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a Scale	Reported bounds
PlaceboBaseline (Day 0)n=100 Participants	1.78	-1.18 - 2.39
Week 1n=100 Participants	-0.24	--0.73 - 0.25
Week 2n=100 Participants	-0.36	--0.84 - 0.12
Week 3n=100 Participants	-0.14	--0.65 - 0.36
Week 4n=100 Participants	-0.44	--0.96 - 0.07
Week 6n=100 Participants	-0.27	--0.96 - 0.42
Week 8n=100 Participants	-0.11	--0.72 - 0.49
Week 10n=100 Participants	-0.17	--0.79 - 0.46
AripiprazoleBaseline (Day 0)n=103 Participants	1.47	-0.87 - 2.07
Week 1n=103 Participants	-0.18	--0.66 - 0.30
Week 2n=103 Participants	-0.21	--0.68 - 0.26
Week 3n=103 Participants	0.23	--0.27 - 0.73
Week 4n=103 Participants	-0.04	--0.55 - 0.47
Week 6n=103 Participants	0.23	--0.45 - 0.91
Week 8n=103 Participants	0.45	--0.15 - 1.05
Week 10n=103 Participants	0.56	--0.05 - 1.17

Secondary/registry result

Change From Baseline in NPI Individual Item Scores in Acute Phase: Sleep

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a Scale	Reported bounds
PlaceboBaseline (Day 0)n=100 Participants	2.67	-1.78 - 3.55
Week 1n=100 Participants	-0.10	--0.84 - 0.64
Week 2n=100 Participants	-0.20	--0.95 - 0.55
Week 3n=100 Participants	-0.20	--0.98 - 0.58
Week 4n=100 Participants	0.02	--0.65 - 0.70
Week 6n=100 Participants	-0.39	--1.12 - 0.34
Week 8n=100 Participants	-0.06	--0.80 - 0.68
Week 10n=100 Participants	0.05	--0.69 - 0.79
AripiprazoleBaseline (Day 0)n=103 Participants	3.03	-2.15 - 3.91
Week 1n=103 Participants	-0.07	--0.81 - 0.67
Week 2n=103 Participants	-0.07	--0.82 - 0.67
Week 3n=103 Participants	0.10	--0.68 - 0.87
Week 4n=103 Participants	0.15	--0.53 - 0.82
Week 6n=103 Participants	-0.03	--0.76 - 0.69
Week 8n=103 Participants	-0.06	--0.79 - 0.68
Week 10n=103 Participants	-0.06	--0.80 - 0.67

Secondary/registry result

Change in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score From Baseline During Extension Phase

Time frame:Baseline (Day 0), Weeks 18,26,40,52,68,84,100,116,132,140

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a Scale	Standard error
AripiprazoleBaseline, Day 0 (n=154)n=158 Participants	12.312	0.426
Week 18 (n=151)n=158 Participants	-8.589	0.548
Week 26 (n=139)n=158 Participants	-8.993	0.589
Week 40 (n=115)n=158 Participants	-8.270	0.677
Week 52 (n=98)n=158 Participants	-8.582	0.672
Week 68 (n=69)n=158 Participants	-9.232	0.824
Week 84 (n=62)n=158 Participants	-10.18	0.848
Week 100 (n=52)n=158 Participants	-10.06	1.031
Week 116 (n=47)n=158 Participants	-10.19	1.183
Week 132 (n=31)n=158 Participants	-11.68	1.554
Week 140 (n=25)n=158 Participants	-13.12	1.586

Safety / tolerability / PK

18 endpoints

Secondary/protocol endpoint

Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events in Acute Phase

Time frame:Week 1 to week 10

event count, event

Secondary/protocol endpoint

Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs in Acute Phase

Time frame:Week 1 to week 10

event count, event

Secondary/protocol endpoint

Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase

Time frame:Week 1 to week 10

descriptive

Secondary/protocol endpoint

Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase

Time frame:Week 1 to Week 10

event count, event

Secondary/protocol endpoint

Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events During Extension Phase

Time frame:Week 11 to Week 140

event count, event

Secondary/protocol endpoint

Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Extension Phase

Time frame:Week 11 to Week 140

event count, event

Secondary/protocol endpoint

Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase

Time frame:Week 11 to Week 140

descriptive

Secondary/protocol endpoint

Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase

Time frame:Week 11 to Week 140

event count, event

Secondary/protocol endpoint

Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Treatment Beyond 140 Weeks

Time frame:Week 140 to Week 328

event count, event

Secondary/registry result

Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events in Acute Phase

Time frame:Week 1 to week 10

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
PlaceboDyskinesian=102 Participants	2	-
Extrapyramidal syndromen=102 Participants	1	-
Hypertonian=102 Participants	1	-
Hypokinesian=102 Participants	0	-
Tremorn=102 Participants	0	-
AripiprazoleDyskinesian=105 Participants	0	-
Extrapyramidal syndromen=105 Participants	2	-
Hypertonian=105 Participants	1	-
Hypokinesian=105 Participants	1	-
Tremorn=105 Participants	2	-

Secondary/registry result

Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs in Acute Phase

Time frame:Week 1 to week 10

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
PlaceboAny adverse event (AE)n=102 Participants	53	-
Serious adverse eventn=102 Participants	9	-
Deathsn=102 Participants	0	-
Discontinuations due to AEn=102 Participants	7	-
AripiprazoleAny adverse event (AE)n=105 Participants	67	-
Serious adverse eventn=105 Participants	16	-
Deathsn=105 Participants	4	-
Discontinuations due to AEn=105 Participants	11	-

Secondary/registry result

Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase

Time frame:Week 1 to week 10

descriptive

Posted result

Group	Value (number), Participants	Reported bounds
PlaceboIncreased Systolic BP, standing; n=99, 100n=102 Participants	5	-
Decreased Systolic BP, standing; n=99, 100n=102 Participants	1	-
Increased Systolic BP, supine; n=101, 102n=102 Participants	6	-
Decreased Systolic BP, supine; n=101, 102n=102 Participants	0	-
Decreased Systolic BP, sitting; n=13, 20n=102 Participants	0	-
Increased Diastolic BP, standing; n=99, 100n=102 Participants	2	-
Decreased Diastolic BP, standing; n=99, 100n=102 Participants	6	-
Increased Diastolic BP, supine; n=101, 102n=102 Participants	2	-
Decreased Diastolic BP, supine; n=101, 102n=102 Participants	4	-
Decreased Diastolic BP, sitting; n=13, 20n=102 Participants	2	-
Increased Heart rate, standing; n=99, 100n=102 Participants	1	-
Decreased Heart rate, standing; n=99, 100n=102 Participants	0	-
Decreased Heart rate, supine; n=101, 102n=102 Participants	1	-
Increased Weight; n=89, 93n=102 Participants	3	-
Decreased Weight; n=89,93n=102 Participants	5	-
AripiprazoleIncreased Systolic BP, standing; n=99, 100n=105 Participants	5	-
Decreased Systolic BP, standing; n=99, 100n=105 Participants	1	-
Increased Systolic BP, supine; n=101, 102n=105 Participants	2	-
Decreased Systolic BP, supine; n=101, 102n=105 Participants	2	-
Decreased Systolic BP, sitting; n=13, 20n=105 Participants	1	-
Increased Diastolic BP, standing; n=99, 100n=105 Participants	2	-
Decreased Diastolic BP, standing; n=99, 100n=105 Participants	3	-
Increased Diastolic BP, supine; n=101, 102n=105 Participants	0	-
Decreased Diastolic BP, supine; n=101, 102n=105 Participants	3	-
Decreased Diastolic BP, sitting; n=13, 20n=105 Participants	0	-
Increased Heart rate, standing; n=99, 100n=105 Participants	0	-
Decreased Heart rate, standing; n=99, 100n=105 Participants	1	-
Decreased Heart rate, supine; n=101, 102n=105 Participants	3	-
Increased Weight; n=89, 93n=105 Participants	5	-
Decreased Weight; n=89,93n=105 Participants	5	-

Secondary/registry result

Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase

Time frame:Week 1 to Week 10

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
PlaceboBradycardia; n=99, 102n=102 Participants	3	-
Sinus Bradycardia; n=99, 102n=102 Participants	2	-
Supraventricular premature beat; n=99, 102n=102 Participants	10	-
Ventricular premature beat; n=99, 102n=102 Participants	7	-
Supraventricular tachycardia; n=99, 102n=102 Participants	1	-
Atrial fibrillation; n=99, 102n=102 Participants	3	-
Atrial flutter; n=99, 102n=102 Participants	0	-
1st degree A-V Block; n=95, 97n=102 Participants	2	-
Left bundle branch block; n=99, 102n=102 Participants	1	-
Right bundle branch block; n=99, 102n=102 Participants	2	-
Other intraventricular conduction block; n=99, 102n=102 Participants	0	-
Subacute infarction; n=99, 102n=102 Participants	1	-
Old infarction; n=99, 102n=102 Participants	2	-
Myocardial ischemia; n=99, 102n=102 Participants	3	-
Symmetrical T-wave inversion; n=99, 102n=102 Participants	2	-
Inc QTcB (≥450 msec≥,10% from baseline); n=99, 102n=102 Participants	5	-
Inc QTcN (≥450 msec,≥10% from baseline); n=99, 102n=102 Participants	1	-
AripiprazoleBradycardia; n=99, 102n=105 Participants	1	-
Sinus Bradycardia; n=99, 102n=105 Participants	1	-
Supraventricular premature beat; n=99, 102n=105 Participants	7	-
Ventricular premature beat; n=99, 102n=105 Participants	12	-
Supraventricular tachycardia; n=99, 102n=105 Participants	0	-
Atrial fibrillation; n=99, 102n=105 Participants	1	-
Atrial flutter; n=99, 102n=105 Participants	1	-
1st degree A-V Block; n=95, 97n=105 Participants	0	-
Left bundle branch block; n=99, 102n=105 Participants	2	-
Right bundle branch block; n=99, 102n=105 Participants	1	-
Other intraventricular conduction block; n=99, 102n=105 Participants	2	-
Subacute infarction; n=99, 102n=105 Participants	0	-
Old infarction; n=99, 102n=105 Participants	2	-
Myocardial ischemia; n=99, 102n=105 Participants	4	-
Symmetrical T-wave inversion; n=99, 102n=105 Participants	1	-
Inc QTcB (≥450 msec≥,10% from baseline); n=99, 102n=105 Participants	5	-
Inc QTcN (≥450 msec,≥10% from baseline); n=99, 102n=105 Participants	2	-

Secondary/registry result

Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events During Extension Phase

Time frame:Week 11 to Week 140

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
AripiprazoleDyskinesian=161 Participants	2	-
Muscle Rigidityn=161 Participants	3	-
Extrapyramidal Disordern=161 Participants	14	-
Hypokinesian=161 Participants	8	-
Tremorn=161 Participants	8	-
Akinesian=161 Participants	1	-
Bradykinesian=161 Participants	1	-
Parkinsonian Gaitn=161 Participants	1	-
Muscle Twitchingn=161 Participants	1	-

Secondary/registry result

Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Extension Phase

Time frame:Week 11 to Week 140

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
AripiprazoleDeathn=161 Participants	41	-
SAEn=161 Participants	59	-
AEn=161 Participants	148	-
Discontinuation due to AEn=161 Participants	66	-

Secondary/registry result

Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase

Time frame:Week 11 to Week 140

descriptive

Posted result

Group	Value (number), Participants	Reported bounds
AripiprazoleIncreased Systolic BP, standing; n=159n=161 Participants	6	-
Decreased Systolic BP, standing; n=159n=161 Participants	9	-
Increased Systolic BP, supine; n=158n=161 Participants	6	-
Decreased Systolic BP, supine; n=158n=161 Participants	7	-
Decreased Systolic BP, sitting; n=45n=161 Participants	1	-
Increased Diastolic BP, standing; n=159n=161 Participants	4	-
Decreased Diastolic BP, standing; n=159n=161 Participants	19	-
Increased Diastolic BP, supine; n=158n=161 Participants	1	-
Decreased Diastolic BP, supine; n=158n=161 Participants	25	-
Decreased Diastolic BP, sitting; n=45n=161 Participants	1	-
Increased Heart rate, standing; n=159n=161 Participants	2	-
Decreased Heart rate, standing; n=159n=161 Participants	3	-
Increased Heart rate, supine; n=158n=161 Participants	1	-
Decreased Heart rate, supine; n=158n=161 Participants	5	-
Increased Weight; n=133n=161 Participants	28	-
Decreased Weight; n=133n=161 Participants	58	-

Secondary/registry result

Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase

Time frame:Week 11 to Week 140

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
AripiprazoleAtrial Fibrillation; n=145n=161 Participants	5	-
Atrial Flutter; n=145n=161 Participants	1	-
Bradycardia; n=145n=161 Participants	4	-
Left Bundle Branch Block; n=145n=161 Participants	5	-
Myocardial Ischemia; n=145n=161 Participants	10	-
Old Infarction; n=145n=161 Participants	2	-
Right Bundle Branch Block; n=145n=161 Participants	3	-
Sinus Bradycardia; n=145n=161 Participants	2	-
Sinus Tachycardia; n=145n=161 Participants	2	-
Supraventricular Premature Beat; n=145n=161 Participants	12	-
Supraventricular Tachycardia; n=145n=161 Participants	2	-
Symmetrical T-wave Inversions; n=145n=161 Participants	8	-
Tachycardia; n=145n=161 Participants	4	-
Ventricular premature Beat; n=145n=161 Participants	13	-

Secondary/registry result

Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Treatment Beyond 140 Weeks

Time frame:Week 140 to Week 328

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
AripiprazoleAny AEn=9 Participants	7	-
SAEn=9 Participants	1	-
Deathn=9 Participants	1	-
Discontinuation due to AEn=9 Participants	3	-

Other clinical outcomes

6 endpoints

Secondary/protocol endpoint

Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score in Acute Phase

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

change from baseline, improvement

Secondary/protocol endpoint

CGI Improvement Score in Acute Phase

Time frame:Weeks 1, 2, 3, 4, 6, 8, and 10

descriptive

Secondary/protocol endpoint

Clinical Global Impression (CGI) Improvement Score During Extension Phase

Time frame:Weeks 12, 14, 18, 22, 26, 30, 34, 40, 46, 52, 68, 84, 100, 116, 132, 140

descriptive

Secondary/registry result

Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score in Acute Phase

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

change from baseline, improvement

Posted result

Group	Value (mean), Units on Scale	Reported spread / bounds
PlaceboBaseline (Day 0)n=100 Participants	4.84	0.094.67 - 5.01
Week 1n=100 Participants	-0.19	0.08-0.34 - -0.04
Week 2n=100 Participants	-0.29	0.11-0.52 - -0.06
Week 3n=100 Participants	-0.44	0.11-0.65 - -0.22
Week 4n=100 Participants	-0.47	0.12-0.70 - -0.24
Week 6n=100 Participants	-0.44	0.12-0.69 - -0.20
Week 8n=100 Participants	-0.56	0.13-0.83 - -0.30
Week 10n=100 Participants	-0.54	0.14-0.82 - -0.26
AripiprazoleBaseline (Day 0)n=102 Participants	4.83	0.094.66 - 5.00
Week 1n=102 Participants	-0.10	0.08-0.25 - 0.05
Week 2n=102 Participants	-0.19	0.12-0.41 - 0.04
Week 3n=102 Participants	-0.44	0.11-0.65 - -0.22
Week 4n=102 Participants	-0.49	0.12-0.73 - -0.26
Week 6n=102 Participants	-0.58	0.12-0.83 - -0.34
Week 8n=102 Participants	-0.65	0.13-0.92 - -0.39
Week 10n=102 Participants	-0.69	0.14-0.98 - -0.41

Secondary/registry result

CGI Improvement Score in Acute Phase

Time frame:Weeks 1, 2, 3, 4, 6, 8, and 10

descriptive

Posted result

Group	Value (mean), Units on Scale	Reported spread / bounds
PlaceboWeek 1; n=98, 102n=100 Participants	3.81	0.090.09 - -
Week 2; n=98, 102n=100 Participants	3.55	0.11
Week 3; n=100, 103n=100 Participants	3.37	0.12
Week 4; n=100, 103n=100 Participants	3.28	0.12
Week 6; n=100, 103n=100 Participants	3.26	0.12
Week 8; n=100, 103n=100 Participants	3.11	0.14
Week 10; n=100, 103n=100 Participants	3.07	0.15
AripiprazoleWeek 1; n=98, 102n=103 Participants	3.96	0.08
Week 2; n=98, 102n=103 Participants	3.71	0.10
Week 3; n=100, 103n=103 Participants	3.49	0.11
Week 4; n=100, 103n=103 Participants	3.32	0.12
Week 6; n=100, 103n=103 Participants	3.23	0.13
Week 8; n=100, 103n=103 Participants	3.16	0.13
Week 10; n=100, 103n=103 Participants	3.17	0.14

p0.133Cochran-Mantel-Haenszel

Analysis at Week 1

p0.282Cochran-Mantel-Haenszel

Analysis at Week 2

p0.571Cochran-Mantel-Haenszel

Analysis at Week 3

p0.895Cochran-Mantel-Haenszel

Analysis at Week 4

p0.817Cochran-Mantel-Haenszel

Analysis at Week 6

p0.795Cochran-Mantel-Haenszel

Analysis at Week 8

p0.564Cochran-Mantel-Haenszel

Analysis at Week 10

Secondary/registry result

Clinical Global Impression (CGI) Improvement Score During Extension Phase

Time frame:Weeks 12, 14, 18, 22, 26, 30, 34, 40, 46, 52, 68, 84, 100, 116, 132, 140

descriptive

Posted result

Group	Value (mean), Units on Scale	Standard error
AripiprazoleWeek 12; n=158n=158 Participants	2.873	0.089
Week 14; n=151n=158 Participants	2.709	0.084
Week 18; n=152n=158 Participants	2.625	0.091
Week 22; n=145n=158 Participants	2.552	0.087
Week 26; n=140n=158 Participants	2.707	0.113
Week 30; n=129n=158 Participants	2.636	0.113
Week 34; n=121n=158 Participants	2.554	0.106
Week 40; n=114n=158 Participants	2.482	0.121
Week 46; n=103n=158 Participants	2.592	0.130
Week 52; n=100n=158 Participants	2.580	0.138
Week 68; n=70n=158 Participants	2.514	0.155
Week 84; n=62n=158 Participants	2.306	0.150
Week 100; n=53n=158 Participants	2.660	0.196
Week 116; n=47n=158 Participants	2.787	0.233
Week 132; n=36n=158 Participants	3.028	0.289
Week 140; n=26n=158 Participants	2.385	0.299

Other (unclassified)

16 endpoints

Secondary/protocol endpoint/low confidence

Change From Baseline in Simpson-Angus Scale (SAS) Total Score in Acute Phase

Time frame:Baseline (Day 0), Weeks 2, 4, and 10

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score in Acute Phase

Time frame:Baseline (Day 0), Weeks 2, 4, 8, and 10

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Barnes Global Clinical Assessment of Akathisia in Acute Phase

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase

Time frame:Week 1 to Week 10

descriptive

Secondary/protocol endpoint/low confidence

Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase

Time frame:End of Acute Phase (Week 10), Weeks 14, 18, 22, 26, 30, 34, 40, 46, 52, 68, 84, 100, 116, 140

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Simpson-Angus Scale (SAS) Total Score During Extension Phase

Time frame:End of Acute Phase (Week 10), Weeks 18,26, 40, 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Barnes Global Clinical Assessment of Akathisia Score During Extension Phase

Time frame:End of Acute Phase (Week 10), Weeks 18,26, 40, 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase

Time frame:Week 11 to Week 140

descriptive

Secondary/registry result/low confidence

Change From Baseline in Simpson-Angus Scale (SAS) Total Score in Acute Phase

Time frame:Baseline (Day 0), Weeks 2, 4, and 10

change from baseline, improvement

Posted result

Group	Value (mean), Units on scale	Reported spread / bounds
PlaceboBaseline (Day 0); n=97, 100n=100 Participants	14.41	NA13.37 - 15.46
Week 2; n=89, 94n=100 Participants	0.02	--0.49 - 0.52
Week 4; n=93, 96n=100 Participants	-0.15	--0.76 - 0.45
Week 10; n=82, 85n=100 Participants	-0.44	--1.19 - 0.31
AripiprazoleBaseline (Day 0); n=97, 100n=103 Participants	14.47	NA13.45 - 15.50
Week 2; n=89, 94n=103 Participants	-0.35	--0.84 - 0.14
Week 4; n=93, 96n=103 Participants	-0.06	--0.65 - 0.54
Week 10; n=82, 85n=103 Participants	0.33	--0.40 - 1.07

Secondary/registry result/low confidence

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score in Acute Phase

Time frame:Baseline (Day 0), Weeks 2, 4, 8, and 10

change from baseline, improvement

Posted result

Group	Value (mean), Units on scale	Reported bounds
PlaceboBaseline (Day 0); n=99, 101n=100 Participants	0.87	-0.32 - 1.42
Week 2; n=91, 95n=100 Participants	-0.10	--0.25 - 0.04
Week 4; n=97, 97n=100 Participants	-0.05	--0.30 - 0.19
Week 8; n=87, 87n=100 Participants	0.07	--0.30 - 0.44
Week 10; n=85, 87n=100 Participants	0.05	--0.33 - 0.43
AripiprazoleBaseline (Day 0); n=99, 101n=103 Participants	0.93	-0.39 - 1.48
Week 2; n=91, 95n=103 Participants	-0.17	--0.32 - -0.03
Week 4; n=97, 97n=103 Participants	-0.08	--0.33 - 0.17
Week 8; n=87, 87n=103 Participants	-0.14	--0.51 - 0.23
Week 10; n=85, 87n=103 Participants	-0.17	--0.55 - 0.20

Secondary/registry result/low confidence

Change From Baseline in Barnes Global Clinical Assessment of Akathisia in Acute Phase

Time frame:Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

change from baseline, improvement

Posted result

Group	Value (mean), Unit on scale	Reported spread / bounds
PlaceboBaseline (Day 0); n=100,101n=100 Participants	0.20	-0.09 - 0.31
Week 1; n=99, 101n=100 Participants	-0.06	--0.12 - 0.00
Week 2; n=91, 95n=100 Participants	-0.02	--0.07 - 0.03
Week 3; n=95, 99n=100 Participants	-0.03	--0.08 - 0.02
Week 4; n=97, 98n=100 Participants	0.00	NA-0.07 - 0.07
Week 6; n=91, 92n=100 Participants	-0.07	--0.14 - -0.01
Week 8; n=87, 87n=100 Participants	-0.05	--0.11 - 0.01
Week 10; n=85, 87n=100 Participants	-0.05	--0.11 - 0.00
AripiprazoleBaseline (Day 0); n=100,101n=103 Participants	0.19	-0.07 - 0.30
Week 1; n=99, 101n=103 Participants	-0.06	--0.12 - 0.00
Week 2; n=91, 95n=103 Participants	-0.05	--0.11 - 0.00
Week 3; n=95, 99n=103 Participants	-0.06	--0.11 - -0.01
Week 4; n=97, 98n=103 Participants	-0.08	--0.15 - -0.02
Week 6; n=91, 92n=103 Participants	-0.02	--0.09 - 0.04
Week 8; n=87, 87n=103 Participants	-0.03	--0.09 - 0.03
Week 10; n=85, 87n=103 Participants	-0.05	--0.11 - 0.01

Secondary/registry result/low confidence

Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase

Time frame:Week 1 to Week 10

descriptive

Posted result

Group	Value (number), Participants	Reported bounds
PlaceboAlanine aminotransferase ≥3 x ULN; n=98, 98n=102 Participants	1	-
Aspartate aminotransferase ≥3 x ULN; n=98, 98n=102 Participants	1	-
Alkaline phosphatase ≥3 x ULN; n=98, 98n=102 Participants	1	-
Creatine phosphokinase (total) ≥3 x ULN; n=98, 98n=102 Participants	1	-
Creatinine ≥ 2.0 mg/dL; n=98, 98n=102 Participants	2	-
Uric acid ≥8.5 mg/dL (F);≥10.5 mg/dL(M); n=98, 98n=102 Participants	5	-
Calcium ≥ 10.6 mg/dL; n=98, 98n=102 Participants	1	-
Calcium ≤ 8.4 mg/dL; n=98, 98n=102 Participants	4	-
Serum Chloride ≥ 113 mEq/L; n=98, 98n=102 Participants	6	-
Serum Chloride ≤ 93 mEq/L; n=98, 98n=102 Participants	5	-
Cholesterol Total > ULN; n=98, 98n=102 Participants	47	-
Cholesterol Total < LLN; n=98, 98n=102 Participants	1	-
Serum Glucose Fasting > ULN; n=36, 31n=102 Participants	13	-
Serum Potassium ≥ 5.6 mEq/L; n=98, 98n=102 Participants	7	-
Serum Potassium ≤ 3.4 mEq/L; n=98, 98n=102 Participants	4	-
Serum Sodium ≥ 148 mEq/L; n=98, 98n=102 Participants	2	-
Serum Sodium ≤ 132 mEq/L; n=98, 98n=102 Participants	3	-
Urea ≥ 10.1mmol/L; n=98, 97n=102 Participants	19	-
Platelet ≥ 700,000 mm3; n=97, 96n=102 Participants	0	-
Platelet ≤ 75,000 mm3; n=97, 96n=102 Participants	1	-
Eosinophils ≥ 10%; n=97, 96n=102 Participants	1	-
Hematocrit ≤ 37% (M)/≤ 32% (F); n=97, 96n=102 Participants	7	-
Hemoglobin ≤ 11.5 (M)/≤ 9.5 g/dL (F); n=97, 96n=102 Participants	6	-
Urine Glucose ≥ 2-unit increase; n=92, 93n=102 Participants	2	-
Urine Protein ≥ 2-unit increase; n=92, 93n=102 Participants	2	-
AripiprazoleAlanine aminotransferase ≥3 x ULN; n=98, 98n=105 Participants	3	-
Aspartate aminotransferase ≥3 x ULN; n=98, 98n=105 Participants	1	-
Alkaline phosphatase ≥3 x ULN; n=98, 98n=105 Participants	0	-
Creatine phosphokinase (total) ≥3 x ULN; n=98, 98n=105 Participants	2	-
Creatinine ≥ 2.0 mg/dL; n=98, 98n=105 Participants	2	-
Uric acid ≥8.5 mg/dL (F);≥10.5 mg/dL(M); n=98, 98n=105 Participants	2	-
Calcium ≥ 10.6 mg/dL; n=98, 98n=105 Participants	2	-
Calcium ≤ 8.4 mg/dL; n=98, 98n=105 Participants	5	-
Serum Chloride ≥ 113 mEq/L; n=98, 98n=105 Participants	4	-
Serum Chloride ≤ 93 mEq/L; n=98, 98n=105 Participants	6	-
Cholesterol Total > ULN; n=98, 98n=105 Participants	36	-
Cholesterol Total < LLN; n=98, 98n=105 Participants	0	-
Serum Glucose Fasting > ULN; n=36, 31n=105 Participants	16	-
Serum Potassium ≥ 5.6 mEq/L; n=98, 98n=105 Participants	7	-
Serum Potassium ≤ 3.4 mEq/L; n=98, 98n=105 Participants	4	-
Serum Sodium ≥ 148 mEq/L; n=98, 98n=105 Participants	1	-
Serum Sodium ≤ 132 mEq/L; n=98, 98n=105 Participants	3	-
Urea ≥ 10.1mmol/L; n=98, 97n=105 Participants	14	-
Platelet ≥ 700,000 mm3; n=97, 96n=105 Participants	1	-
Platelet ≤ 75,000 mm3; n=97, 96n=105 Participants	0	-
Eosinophils ≥ 10%; n=97, 96n=105 Participants	1	-
Hematocrit ≤ 37% (M)/≤ 32% (F); n=97, 96n=105 Participants	6	-
Hemoglobin ≤ 11.5 (M)/≤ 9.5 g/dL (F); n=97, 96n=105 Participants	4	-
Urine Glucose ≥ 2-unit increase; n=92, 93n=105 Participants	0	-
Urine Protein ≥ 2-unit increase; n=92, 93n=105 Participants	1	-

Secondary/registry result/low confidence

Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase

Time frame:End of Acute Phase (Week 10), Weeks 14, 18, 22, 26, 30, 34, 40, 46, 52, 68, 84, 100, 116, 140

change from baseline, improvement

Posted result

Group	Value (mean), Units on Scale	Standard error
AripiprazoleEnd of Acute Phase (Week 10); n=157n=158 Participants	0.95	0.20
Week 14; n=151n=158 Participants	0.25	0.12
Week 18; n=152n=158 Participants	0.09	0.11
Week 22; n=145n=158 Participants	0.02	0.13
Week 26; n=140n=158 Participants	-0.12	0.13
Week 30; n=128n=158 Participants	-0.01	0.10
Week 34; n=121n=158 Participants	-0.10	0.15
Week 40; n=115n=158 Participants	-0.01	0.16
Week 46; n=104n=158 Participants	-0.02	0.15
Week 52; n=100n=158 Participants	-0.02	0.20
Week 68; n=70n=158 Participants	-0.29	0.17
Week 84; n=62n=158 Participants	-0.24	0.17
Week 100; n=52n=158 Participants	-0.21	0.15
Week 116; n=47n=158 Participants	-0.21	0.20
Week 140; n=15n=158 Participants	0.00	0.20
Endpoint (LOCF data set); n=157n=158 Participants	-0.03	0.15

Secondary/registry result/low confidence

Change in Simpson-Angus Scale (SAS) Total Score During Extension Phase

Time frame:End of Acute Phase (Week 10), Weeks 18,26, 40, 52

change from baseline, improvement

Posted result

Group	Value (mean), Units on Scale	Standard error
AripiprazoleEnd of Acute Phase (Week 10); n=153n=158 Participants	14.34	0.40
Week 18; n=148n=158 Participants	0.62	0.23
Week 26; n=132n=158 Participants	1.24	0.31
Week 40; n=107n=158 Participants	1.25	0.39
Week 52; n=95n=158 Participants	1.14	0.40
Endpoint (LOCF data set); n=153n=158 Participants	2.01	0.37

Secondary/registry result/low confidence

Change in Barnes Global Clinical Assessment of Akathisia Score During Extension Phase

Time frame:End of Acute Phase (Week 10), Weeks 18,26, 40, 52

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard error
AripiprazoleEnd of Acute Phase (Week 10); n=155n=158 Participants	0.14	0.03
Week 18; n=151n=158 Participants	0.04	0.03
Week 26; n=139n=158 Participants	0.03	0.04
Week 40; n=114n=158 Participants	0.04	0.04
Week 52; n=99n=158 Participants	0.06	0.03
Endpoint (LOCF data set); n=155n=158 Participants	0.06	0.03

Secondary/registry result/low confidence

Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase

Time frame:Week 11 to Week 140

descriptive

Posted result

Group	Value (number), Participants	Reported bounds
AripiprazoleHigh Alanine aminotransferase; ≥ 41 U/Ln=161 Participants	0	-
High Aspartate aminotransferase; ≥ 38 U/Ln=161 Participants	1	-
High Alkaline phosphatase; ≥ 117 U/Ln=161 Participants	2	-
High Lactate dehydrogenase; >480 U/Ln=161 Participants	1	-
High Urea; >8.4 mmol/Ln=161 Participants	56	-
High Creatinine; ≥ 2.0 mg/dLn=161 Participants	8	-
High Uric acid; >5.7 mg/dLn=161 Participants	9	-
High Total Billirubin; > 1 mg/dLn=161 Participants	0	-
High Creatinine Kinase; ≥ 170 U/Ln=161 Participants	2	-
High Serum Glucose Fasting; >118 mg/dLn=161 Participants	36	-
High Serum Glucose Non-fasting; >118 mg/dLn=161 Participants	17	-
High Cholesterol Total; > 220mg/dLn=161 Participants	131	-
High Serum Calcium; >10.2 mg/dLn=161 Participants	5	-
Low Serum Calcium; <8.6 mg/dLn=161 Participants	26	-
High Serum Chloride; >108 mEq/Ln=161 Participants	24	-
Low Serum Chloride; <96 mEq/Ln=161 Participants	36	-
High Serum Potassium; >5.1 mEq/Ln=161 Participants	36	-
Low Serum Potassium; <3.3mEq/Ln=161 Participants	11	-
High Serum Sodium; > 145 mEq/Ln=161 Participants	13	-
Low Serum Sodium; < 133 mEq/Ln=161 Participants	12	-
Low Hematocrit; <37%n=161 Participants	21	-
Low Hemoglobin; < 12 g/dLn=161 Participants	19	-
High Leukocyte count; > 10.8 x 10^3 c/uLn=161 Participants	7	-
Low Leukocyte count: < 4.8 x 10^3 c/uLn=161 Participants	4	-
High Eosinophil count; > 5%n=161 Participants	3	-
High Platelet count; >450 x 10^9 c/Ln=161 Participants	0	-
Low Platelet count; < 150 x 10^9 c/Ln=161 Participants	1	-
High Urine Protein; ≥ 2-unit increasen=161 Participants	2	-
High Urine Glucose; ≥ 2-unit increasen=161 Participants	3	-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.