Phase 2
N=132
Treatment for Aggression and Agitation in Patients With Alzheimer's Disease
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00843518 ↗Enrolled (actual)
132
Serious AEs
2.8%
Results posted
Nov 2017
Primary outcome: Primary: Mean Change From Baseline in the 4-Item Agitation/Aggression Subscale of the Neuropsychiatric Inventory (NPI-4 A/A) at Week 12 — -5.4; -6.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LY451395 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in the 4-Item Agitation/Aggression Subscale of the Neuropsychiatric Inventory (NPI-4 A/A) at Week 12 |
-5.4; -6.2 | — |
| SECONDARY Mean Change From Baseline in 10-Item Version of Neuropsychiatric Inventory (NPI-10) at Week 12 |
-8.2; -9.3 | — |
| SECONDARY Mean Change From Baseline in the Neuropsychiatric Inventory (NPI) Depression Domain at Week 12 |
-0.2; -1.0 | — |
| SECONDARY Mean Change From Baseline in the Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 12 |
-0.4; -0.4 | — |
| SECONDARY Mean Change From Baseline in Cohen-Mansfield Agitation Inventory-Community Version (CMAI-C) at Week 12 |
-7.2; -4.1 | — |
| SECONDARY Mean Change From Baseline in Cornell Scale for Depression in Dementia (CSDD) at Week 12 |
-2.5; -2.7 | — |
| SECONDARY Mean Change From Baseline in Total T-Score in the Frontal System Behaviors Scale (FrSBe) at Week 12 |
-2.2; 2.3 | — |
| SECONDARY Mean Change From Baseline in Clinical Global Impression-Severity-Agitation/Aggression (CGI-S-A/A) at Week 12 |
-0.7; -0.6 | — |
| SECONDARY Mean Change From Baseline in Clinical Global Impression-Severity-Global Functioning (CGI-S-GF) at Week 12 |
-0.2; -0.03 | — |
| SECONDARY Mean Change From Baseline in the 14-Item Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog14) at Week 12 |
-0.1; -0.6 | — |
Summary
The purpose of this study is to determine whether this drug can help symptoms of aggression and agitation in participants with Alzheimer's disease.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00843518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.