Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
NCT ID: NCT01735630
Last Updated: 2019-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
350 participants
INTERVENTIONAL
2012-11-30
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ELND005
ELND005 film coated tablets, BID for 12 weeks
ELND005
Placebo
Matched placebo BID for 12 weeks
Placebo
Interventions
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ELND005
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* MMSE score of 5 to 24 (inclusive) at the Screening Visit.
* Has clinically significant agitation/aggression defined as Neuropsychiatric Inventory (NPI)-agitation/aggression subscore of ≥4.
* No response or suboptimal response to standard nonpharmacological interventions.
Exclusion Criteria
* Current diagnosis of major depressive disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision (DSM IV TR).
* Has persistent and distressing psychotic symptoms (delusion and/or hallucinations) that require psychiatric hospitalization.
50 Years
95 Years
ALL
No
Sponsors
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Elan Pharmaceuticals
INDUSTRY
OPKO Health, Inc.
INDUSTRY
Responsible Party
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Locations
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TransitionTIL Investigational Site
Birmingham, Alabama, United States
TransitionTIL Investigational Site
Phoenix, Arizona, United States
TransitionTIL Investigational Site
Phoenix, Arizona, United States
TransitionTIL Investigational Site
Encino, California, United States
TransitionTIL Investigational Site
Escondido, California, United States
TransitionTIL Investigational Site
Fresno, California, United States
TransitionTIL Investigational Site
Irvine, California, United States
TransitionTIL Investigational Site
Long Beach, California, United States
TransitionTIL Investigational Site
Los Alamitos, California, United States
TransitionTIL Investigational Site
Los Angeles, California, United States
TransitionTIL Investigational Site
Newport Beach, California, United States
TransitionTIL Investigational Site
Santa Ana, California, United States
TransitionTIL Investigational Site
Norwalk, Connecticut, United States
TransitionTIL Investigational Site
Washington D.C., District of Columbia, United States
TransitionTIL Investigational Site
Atlantis, Florida, United States
TransitionTIL Investigational Site
Deerfield Beach, Florida, United States
TransitionTIL Investigational Site
Delray Beach, Florida, United States
TransitionTIL Investigational Site
Lake Worth, Florida, United States
TransitionTIL Investigational Site
Miami, Florida, United States
TransitionTIL Investigational Site
Oakland Park, Florida, United States
TransitionTIL Investigational Site
Orlando, Florida, United States
TransitionTIL Investigational Site
Ormond Beach, Florida, United States
TransitionTIL Investigational Site
Port Charlotte, Florida, United States
TransitionTIL Investigational Site
Sarasota, Florida, United States
TransitionTIL Investigational Site
Sunrise, Florida, United States
TransitionTIL Investigational Site
Columbus, Georgia, United States
TransitionTIL Investigational Site
Savannah, Georgia, United States
TransitionTIL Investigational Site
Springfield, Illinois, United States
TransitionTIL Investigational Site
Bangor, Maine, United States
TransitionTIL Investigational Site
Easton, Maryland, United States
TransitionTIL Investigational Site
Winchester, Massachusetts, United States
TransitionTIL Investigational Site
Ann Arbor, Michigan, United States
TransitionTIL Investigational Site
Paw Paw, Michigan, United States
TransitionTIL Investigational Site
Saint Paul, Minnesota, United States
TransitionTIL Investigational Site
Hattiesburg, Mississippi, United States
TransitionTIL Investigational Site
Stratford, New Jersey, United States
TransitionTIL Investigational Site
Rochester, New York, United States
TransitionTIL Investigational Site
Rochester, New York, United States
TransitionTIL Investigational Site
Charlotte, North Carolina, United States
TransitionTIL Investigational Site
Charlotte, North Carolina, United States
TransitionTIL Investigational Site
Durham, North Carolina, United States
TransitionTIL Investigational Site
Wilmington, North Carolina, United States
TransitionTIL Investigational Site
Winston-Salem, North Carolina, United States
TransitionTIL Investigational Site
Oklahoma City, Oklahoma, United States
TransitionTIL Investigational Site
Portland, Oregon, United States
TransitionTIL Investigational Site
Abington, Pennsylvania, United States
TransitionTIL Investigational Site
Jenkintown, Pennsylvania, United States
TransitionTIL Investigational Site
Norristown, Pennsylvania, United States
TransitionTIL Investigational Site
Philadelphia, Pennsylvania, United States
TransitionTIL Investigational Site
Philadelphia, Pennsylvania, United States
TransitionTIL Investigational Site
Pittsburgh, Pennsylvania, United States
TransitionTIL Investigational Site
North Charleston, South Carolina, United States
TransitionTIL Investigational Site
Port Royal, South Carolina, United States
TransitionTIL Investigational Site
Nashville, Tennessee, United States
TransitionTIL Investigational Site
DeSoto, Texas, United States
TransitionTIL Investigational Site
Richmond, Virginia, United States
TransitionTIL Investigational Site
Bellevue, Washington, United States
TransitionTIL Investigational Site
Calgary, Alberta, Canada
TransitionTIL Investigational Site
Kelowna, British Columbia, Canada
TransitionTIL Investigational Site
Toronto, Ontario, Canada
TransitionTIL Investigational Site
Toronto, Ontario, Canada
TransitionTIL Investigational Site
Regina, Saskatchewan, Canada
TransitionTIL Investigational Site
Elche, Alicante, Spain
TransitionTIL Investigational Site
Getxo, Biscay, Spain
TransitionTIL Investigational Site
Barcelona, , Spain
TransitionTIL Investigational Site
Barcelona, , Spain
TransitionTIL Investigational Site
Burgos, , Spain
TransitionTIL Investigational Site
Madrid, , Spain
TransitionTIL Investigational Site
Bath, , United Kingdom
TransitionTIL Investigational Site
Swindon, , United Kingdom
Countries
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Other Identifiers
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2012-004299-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ELND005-AG201
Identifier Type: -
Identifier Source: org_study_id
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