Conditions

Agitation and Aggression

Outcome Measures

Mean Change From Baseline in the 4-Item Agitation/Aggression Subscale of the Neuropsychiatric Inventory (NPI-4 A/A) at Week 12
NPI assessed noncognitive psychopathology in participants with Alzheimer's dementia. A 4-item subscale of the standard 12-item NPI measured the neuropsychiatric symptoms of A/A, with items consisting of agitation/aggression, aberrant motor behavior, irritability/emotional lability, and disinhibition. Scores for each subscale (frequency x severity) were calculated to obtain each item score. The total subscale score ranged from 0 to 48, with higher scores indicating more frequent and/or severe A/A symptoms. If a symptom was not present at all, the site would not enter anything for frequency or severity, and a zero would be imputed for that item. Least Squares (LS) Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline NPI-4 A/A, and baseline-by-visit interaction.
Baseline, Week 12

Mean Change From Baseline in 10-Item Version of Neuropsychiatric Inventory (NPI-10) at Week 12
Baseline, Week 12
Mean Change From Baseline in the Neuropsychiatric Inventory (NPI) Depression Domain at Week 12
Baseline, Week 12
Mean Change From Baseline in the Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 12
Baseline, Week 12
Mean Change From Baseline in Cohen-Mansfield Agitation Inventory-Community Version (CMAI-C) at Week 12
Baseline, Week 12
Mean Change From Baseline in Cornell Scale for Depression in Dementia (CSDD) at Week 12
Baseline, Week 12
+4 more secondary outcomes

EXPERIMENTAL

3 milligram (mg) LY451395 orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate

Drug: LY451395

PLACEBO COMPARATOR

Placebo orally twice daily for 12 weeks

Drug: Placebo

3 mg LY451395 orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate

Also known as: mibampator

LY451395

Placebo orally twice daily for 12 weeks

Placebo

Age60 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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.

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.

Contact the study team to confirm eligibility.