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

Lilly

Status and phase

Completed

Phase 2

Conditions

Alzheimer's Disease

Treatments

Drug: Placebo

Drug: LY451395

Study type

Interventional

Funder types

Industry

Identifiers

H6N-MC-LEAQ (Other Identifier)

12541

Details and patient eligibility

About

The purpose of this study is to determine whether this drug can help symptoms of aggression and agitation in participants with Alzheimer's disease.

Full description

The primary purpose of this study is to help answer the following research questions:

Whether this drug can help symptoms of aggression and agitation in participants with Alzheimer's Disease.
The safety of this drug and any side effects that might be associated with it.
How this drug compares to placebo.

During the 12-week period of this study, the participant will have an equal chance of receiving 1 of the 2 treatment groups: active drug or placebo.

Enrollment

132 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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.