Status:
COMPLETED
Treatment for Aggression and Agitation in Patients With Alzheimer's Disease
Lead Sponsor:
Eli Lilly and Company
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief 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.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00843518
Start Date
February 1 2009
End Date
June 1 2011
Last Update
November 29 2017
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Phoenix, Arizona, United States, 85006
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Costa Mesa, California, United States, 92626
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hamden, Connecticut, United States, 06518
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Orlando, Florida, United States, 32806