Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease



Status:Completed
Conditions:Alzheimer Disease, Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:50 - 95
Updated:4/21/2016
Start Date:November 2012
End Date:May 2015

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Trial Summary
Trial Overview
Inclusion Criteria

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Efficacy and Safety Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease

The primary purpose of this study is to determine whether ELND005 is effective in treating
symptoms of agitation and aggression in patients with Alzheimer's disease


Inclusion Criteria:

- Diagnosis of Probable AD according to the National Institute on Aging- Alzheimer's
Association (NIA-AA) guidelines (McKhann et al 2011).

- 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:

- The agitation/aggression is attributable to concomitant medications, environmental
conditions, or active medical or psychiatric condition.

- 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.
We found this trial at
58
sites
TransitionTIL Investigational Site
Easton, Maryland 21601
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Abington, Pennsylvania 19001
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Abington, PA
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Ann Arbor, Michigan 48105
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Ann Arbor, MI
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Atlantis, Florida 33462
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Atlantis, FL
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Bangor, Maine 04402
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Bangor, ME
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Bellevue, Washington 98007
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Bellevue, WA
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Birmingham, Alabama 35294
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Birmingham, AL
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Calgary, Alberta
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Calgary,
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Charlotte, North Carolina 28209
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Charlotte, NC
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Charlotte, North Carolina 28209
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Charlotte, NC
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Columbus, Georgia 31909
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Columbus, GA
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Deerfield Beach, Florida 33064
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Deerfield Beach, FL
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Delray Beach, Florida 33445
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Delray Beach, FL
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DeSoto, Texas 75115
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DeSoto, TX
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Durham, North Carolina 27710
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Durham, NC
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Encino, California 91316
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Encino, CA
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Escondido, California 92025
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Escondido, CA
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Fresno, California 93710
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Fresno, CA
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Hattiesburg, Mississippi 39401
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Hattiesburg, MS
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Irvine, California 92697
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Irvine, CA
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Jenkintown, Pennsylvania 19046
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Jenkintown, PA
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Lake Worth, Florida 33449
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Lake Worth, FL
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Long Beach, California 90806
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Long Beach, CA
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Los Alamitos, California 90720
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Los Alamitos, CA
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Los Angeles, California 90073
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Los Angeles, CA
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Miami, Florida 33137
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Miami, FL
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Nashville, Tennessee 37212
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Nashville, TN
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Newport Beach, California 92663
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Newport Beach, CA
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Norristown, Pennsylvania 19401
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Norristown, PA
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North Charleston, South Carolina 29406
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North Charleston, SC
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Norwalk, Connecticut 06851
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Norwalk, CT
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Oakland Park, Florida 33334
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Oakland Park, FL
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Oklahoma City, Oklahoma 73112
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Oklahoma City, OK
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Orlando, Florida 32806
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Orlando, FL
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Ormond Beach, Florida 32174
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Ormond Beach, FL
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Paw Paw, Michigan 49079
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Paw Paw, MI
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Phoenix, Arizona 85006
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Phoenix, AZ
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Phoenix, Arizona 85006
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Pittsburgh, Pennsylvania 15213
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Port Charlotte, Florida 33952
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Port Charlotte, FL
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Port Royal, South Carolina 29935
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Port Royal, SC
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Portland, Oregon 97225
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Portland, OR
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Richmond, Virginia 23230
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Richmond, VA
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Rochester, New York 14623
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Rochester, NY
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Rochester, New York 14623
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Rochester, NY
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Santa Ana, California 92701
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Santa Ana, CA
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Sarasota, Florida 34243
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Sarasota, FL
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Savannah, Georgia 31419
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Savannah, GA
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Springfield, Illinois 62702
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Springfield, IL
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St. Paul, Minnesota 55130
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Stratford, New Jersey 08084
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Stratford, NJ
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Sunrise, Florida 33351
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Washington, District of Columbia 20057
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Wilmington, North Carolina 28401
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Winchester, Massachusetts 01890
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Winston-Salem, North Carolina 27103
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