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

This study has been completed.
Sponsor:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Alzheimer Disease
Aggression
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 18, 2014