Treatment for Aggression and Agitation in Patients With Alzheimer's Disease
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00843518
First received: February 12, 2009
Last updated: September 20, 2011
Last verified: August 2011
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Purpose
The purpose of this study is to determine whether this drug can help symptoms of aggression and agitation in patients with Alzheimer's disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: LY451395 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Assessment of LY451395 for Neuropsychiatric Symptoms of Aggression and Agitation in Alzheimer's Disease |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Mean change in the 4-item agitation/aggression subscale of the Neuropsychiatric Inventory (NPI-12). Change in measurement of verbal and physical agitation and aggression symptoms. [ Time Frame: At baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, and 13 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Efficacy by means of the Cohen-Mansfield Agitation Inventory (CMAI-C) [ Time Frame: At baseline, 3 weeks, 6 weeks, 9 weeks, and 12 weeks ] [ Designated as safety issue: No ]
- Efficacy by means of the Neuropsychiatric Inventory -10 item Version (NPI-10) [ Time Frame: At baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, and 13 weeks ] [ Designated as safety issue: No ]
- Efficacy by means of the Cornell Scale for Depression in Dementia (CSDD) [ Time Frame: At baseline, 6 weeks, and 12 weeks ] [ Designated as safety issue: No ]
- Efficacy by means of the Frontal System Behaviors Scale (FrsBe) [ Time Frame: At baseline, 6 weeks, and 12 weeks ] [ Designated as safety issue: No ]
- Efficacy by means of the Clinical Global Impression-Severity-Agitation/Aggressive (CGI-S-A/A) [ Time Frame: At baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week, 11, week 12, and week 13 ] [ Designated as safety issue: No ]
- By means of the Clinical Global Impression,Severity-Global Functioning (CGI-S-GF) [ Time Frame: At baseline, 6 weeks, and 12 weeks ] [ Designated as safety issue: No ]
- Efficacy by means of the Alzheimer's Disease Assessment Scale, Cognitive, Subscale 14-item(ADAS-Cog) [ Time Frame: At baseline, 6 weeks, and 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 98 |
| Study Start Date: | February 2009 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: LY451395 |
Drug: LY451395
3 mg BID oral 12 weeks. May be reduced to 1 mg if unable to tolerate
Other Name: LY451395
|
| Placebo Comparator: Placebo |
Drug: LY451395
3 mg BID oral 12 weeks. May be reduced to 1 mg if unable to tolerate
Other Name: LY451395
Drug: Placebo
BID oral 12 weeks
|
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 subjects 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 patient will have an equal chance of receiving 1 of the 2 treatment groups the active drug or the placebo.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Community-dwelling patients with a diagnosis of probable Alzheimer's disease (AD), based on the disease diagnostic criteria, and with Mini Mental State Examination (MMSE) score from 6 to 26 inclusive, NPI-10 total score greater than or equal to 10, and significant neuropsychiatric symptoms.
- Are men or women at least 60 years old.
- Weigh greater than or equal to 45 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.
- 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:
- Have delirium.
- Meet criteria for vascular dementia.
- Have an MRI or 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 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00843518
Locations
| United States, Arizona | |
| 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 | |
| United States, California | |
| 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 | |
| United States, Connecticut | |
| 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 | |
| United States, Florida | |
| 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 | |
| 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. | |
| Tampa, Florida, United States, 33609 | |
| 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. | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Georgia | |
| 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, 30308 | |
| United States, Maryland | |
| 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. | |
| Easton, Maryland, United States, 21601 | |
| United States, Mississippi | |
| 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. | |
| Flowood, Mississippi, United States, 39232 | |
| United States, New Jersey | |
| 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. | |
| Toms River, New Jersey, United States, 08755 | |
| United States, New York | |
| 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. | |
| Staten Island, New York, United States, 10312 | |
| United States, North Carolina | |
| 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. | |
| Hickory, North Carolina, United States, 28601 | |
| United States, Oregon | |
| 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. | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| 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. | |
| Norristown, Pennsylvania, United States, 19401 | |
| United States, Texas | |
| 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. | |
| Austin, Texas, United States, 78757 | |
| United States, Vermont | |
| 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, 05201 | |
| United States, Wisconsin | |
| 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, 53188 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | 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 | Eli Lilly and Company |
More Information
No publications provided by Eli Lilly and Company
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00843518 History of Changes |
| Other Study ID Numbers: | 12541, H6N-MC-LEAQ |
| Study First Received: | February 12, 2009 |
| Last Updated: | September 20, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Eli Lilly and Company:
|
Agitation and Aggression |
Additional relevant MeSH terms:
|
Aggression Alzheimer Disease Psychomotor Agitation Behavioral Symptoms Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies |
Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Dyskinesias Neurologic Manifestations Psychomotor Disorders Neurobehavioral Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013