Treatment for Aggression and Agitation in Patients With Alzheimer's Disease
NCT ID: NCT00843518
Last Updated: 2017-11-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
132 participants
INTERVENTIONAL
2009-02-28
2011-06-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LY451395
3 milligram (mg) LY451395 orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate
LY451395
3 mg LY451395 orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate
Placebo
Placebo orally twice daily for 12 weeks
Placebo
Placebo orally twice daily for 12 weeks
Interventions
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LY451395
3 mg LY451395 orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate
Placebo
Placebo orally twice daily for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877.CTLilly (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM-5PM Easter time (UTC/GMT-5 hours, EST
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
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
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Hamden, Connecticut, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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.
Atlanta, Georgia, United States
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Easton, Maryland, United States
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Flowood, Mississippi, United States
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Toms River, New Jersey, United States
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Staten Island, New York, United States
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Hickory, North Carolina, United States
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Portland, Oregon, United States
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Norristown, Pennsylvania, United States
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Austin, Texas, United States
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.
Bennington, Vermont, United States
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.
Waukesha, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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H6N-MC-LEAQ
Identifier Type: OTHER
Identifier Source: secondary_id
12541
Identifier Type: -
Identifier Source: org_study_id