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CompletedPhase 2Results posted

Treatment for Aggression and Agitation in Patients With Alzheimer's Disease

Assessment of LY451395 for Neuropsychiatric Symptoms of Aggression and Agitation in Alzheimer's Disease

Lead sponsor

Eli Lilly and Company

Asset

LY451395

Listed sites

Recruiting sites

Enrollment

132

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 6-26•Study partner/caregiver required

Primary endpoint

•Neuropsychiatric Inventory (NPI)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID12541

Secondary IDH6N-MC-LEAQEli Lilly and Company

NCT IDNCT00843518

Timeline

Milestones

Study start2009-02 (month precision)

Study first posted2009-02-13estimated

Primary completion2011-06actual (month precision)

Study completion2011-06actual (month precision)

Last update posted2017-11-29actual

Results first posted2017-11-29actual

Assets

Drug assets

LY451395

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Community-dwelling participants with a diagnosis of probable Alzheimer's disease (AD) based on disease criteria from the National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and the Alzheimer's Association. Mini Mental State Examination (MMSE) score from 6 to 26 inclusive; Neuropsychiatric Inventory-10 (NPI-10) total score greater than or equal to 10.

•Are men or women at least 60 years old.

•Weight greater than or equal to 45 kilograms (kg).

•Have clinically significant and persistent verbal or physical agitation and/or verbal or physical aggression behaviors that are disruptive to daily functioning or potentially harmful and occurred at least 3 days per week over the past 4 weeks prior to study entry.

•Understand English.

•Have a reliable and actively involved caregiver who must be able to communicate in English and be willing to comply with protocol requirements

Exclusion criteria

•Meet DSM-IV-TR or Delirium Rating Scale-Revised-98 criteria for delirium.

•Does not score ≤4 on the Modified Hachinski Ischemia Scale for vascular dementia.

•Have a magnetic resonance imaging (MRI) or computer tomography (CT) scan on file since the onset of symptoms of AD and performed within the past 24 months that is inconsistent with a diagnosis of AD.

•Have a current, required use, or expected use of psychoactive drugs or other medications not allowed in this trial.

•Have currently active significant medical, neurological, or psychiatric problems that are not allowed in this trial or other brain disorders.

•Have received acetylcholinesterase inhibitor (AChEIs) or memantine for less than 4 months, or have less than 2 months of stable therapy on these treatments by Visit 2.

Endpoints (20)

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

Global cognition

Executive function / language

Global cognition

2 endpoints

Secondary/protocol endpoint

Mean Change From Baseline in the 14-Item Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog14) at Week 12

Time frame:Baseline, Week 12

ADAS-Cog

change from baseline, improvement

Secondary/registry result

Mean Change From Baseline in the 14-Item Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog14) at Week 12

Time frame:Baseline, Week 12

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
LY451395n=43 Participants	-0.1	0.98
Placebon=49 Participants	-0.6	0.92

Executive function / language

2 endpoints

Secondary/protocol endpoint

Mean Change From Baseline in Total T-Score in the Frontal System Behaviors Scale (FrSBe) at Week 12

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Mean Change From Baseline in Total T-Score in the Frontal System Behaviors Scale (FrSBe) at Week 12

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
LY451395n=42 Participants	-2.2	2.02
Placebon=49 Participants	2.3	1.88

Behavior / neuropsychiatric

16 endpoints

Primary/protocol endpoint

Mean Change From Baseline in the 4-Item Agitation/Aggression Subscale of the Neuropsychiatric Inventory (NPI-4 A/A) at Week 12

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Primary/registry result

Mean Change From Baseline in the 4-Item Agitation/Aggression Subscale of the Neuropsychiatric Inventory (NPI-4 A/A) at Week 12

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
LY451395n=43 Participants	-5.4	1.21
Placebon=50 Participants	-6.2	1.12

Secondary/protocol endpoint

Mean Change From Baseline in 10-Item Version of Neuropsychiatric Inventory (NPI-10) at Week 12

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in the Neuropsychiatric Inventory (NPI) Depression Domain at Week 12

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in the Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 12

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Cohen-Mansfield Agitation Inventory-Community Version (CMAI-C) at Week 12

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Cornell Scale for Depression in Dementia (CSDD) at Week 12

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Clinical Global Impression-Severity-Agitation/Aggression (CGI-S-A/A) at Week 12

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Clinical Global Impression-Severity-Global Functioning (CGI-S-GF) at Week 12

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Mean Change From Baseline in 10-Item Version of Neuropsychiatric Inventory (NPI-10) at Week 12

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
LY451395n=43 Participants	-8.2	2.08
Placebon=50 Participants	-9.3	1.93

Secondary/registry result

Mean Change From Baseline in the Neuropsychiatric Inventory (NPI) Depression Domain at Week 12

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
LY451395n=43 Participants	-0.2	0.34
Placebon=50 Participants	-1.0	0.32

Secondary/registry result

Mean Change From Baseline in the Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 12

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
LY451395n=43 Participants	-0.4	0.58
Placebon=50 Participants	-0.4	0.54

Secondary/registry result

Mean Change From Baseline in Cohen-Mansfield Agitation Inventory-Community Version (CMAI-C) at Week 12

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
LY451395n=42 Participants	-7.2	1.98
Placebon=50 Participants	-4.1	1.79

Secondary/registry result

Mean Change From Baseline in Cornell Scale for Depression in Dementia (CSDD) at Week 12

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
LY451395n=39 Participants	-2.5	0.59
Placebon=47 Participants	-2.7	0.54

Secondary/registry result

Mean Change From Baseline in Clinical Global Impression-Severity-Agitation/Aggression (CGI-S-A/A) at Week 12

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
LY451395n=43 Participants	-0.7	0.15
Placebon=50 Participants	-0.6	0.14

Secondary/registry result

Mean Change From Baseline in Clinical Global Impression-Severity-Global Functioning (CGI-S-GF) at Week 12

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
LY451395n=43 Participants	-0.2	0.11
Placebon=50 Participants	-0.03	0.11

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Trzepacz PT, Cummings J, Konechnik T, Forrester TD, Chang C, Dennehy EB, Willis BA, Shuler C, Tabas LB, Lyketsos C. Mibampator (LY451395) randomized clinical trial for agitation/aggression in Alzheimer's disease. Int Psychogeriatr. 2013 May;25(5):707-19. doi: 10.1017/S1041610212002141. Epub 2012 Dec 21.
PMID23257314via DERIVED

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.