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
Fresno, California 93710
1989
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from 43215
Fresno, CA
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Abington, Pennsylvania 19001
418
mi
from 43215
Abington, PA
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Ann Arbor, Michigan 48105
164
mi
from 43215
Ann Arbor, MI
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Atlantis, Florida 33462
939
mi
from 43215
Atlantis, FL
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Bangor, Maine 04402
798
mi
from 43215
Bangor, ME
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Bellevue, Washington 98007
1998
mi
from 43215
Bellevue, WA
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Birmingham, Alabama 35294
491
mi
from 43215
Birmingham, AL
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Calgary, Alberta
1670
mi
from 43215
Calgary,
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Charlotte, North Carolina 28209
348
mi
from 43215
Charlotte, NC
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TransitionTIL Investigational Site
Charlotte, North Carolina 28209
348
mi
from 43215
Charlotte, NC
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TransitionTIL Investigational Site
Columbus, Georgia 31909
524
mi
from 43215
Columbus, GA
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Deerfield Beach, Florida 33064
960
mi
from 43215
Deerfield Beach, FL
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Delray Beach, Florida 33445
947
mi
from 43215
Delray Beach, FL
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DeSoto, Texas 75115
922
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from 43215
DeSoto, TX
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Durham, North Carolina 27710
354
mi
from 43215
Durham, NC
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TransitionTIL Investigational Site
Easton, Maryland 21601
379
mi
from 43215
Easton, MD
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Encino, California 91316
1983
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from 43215
Encino, CA
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Escondido, California 92025
1936
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Escondido, CA
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Hattiesburg, Mississippi 39401
692
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from 43215
Hattiesburg, MS
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Irvine, California 92697
1961
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Irvine, CA
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Jenkintown, Pennsylvania 19046
417
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from 43215
Jenkintown, PA
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Lake Worth, Florida 33449
937
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from 43215
Lake Worth, FL
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Long Beach, California 90806
1976
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from 43215
Long Beach, CA
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Los Alamitos, California 90720
1969
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from 43215
Los Alamitos, CA
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Los Angeles, California 90073
1972
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Los Angeles, CA
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Miami, Florida 33137
993
mi
from 43215
Miami, FL
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Nashville, Tennessee 37212
334
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from 43215
Nashville, TN
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Newport Beach, California 92663
1967
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Newport Beach, CA
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Norristown, Pennsylvania 19401
406
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from 43215
Norristown, PA
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North Charleston, South Carolina 29406
514
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from 43215
North Charleston, SC
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Norwalk, Connecticut 06851
510
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Norwalk, CT
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Oakland Park, Florida 33334
966
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from 43215
Oakland Park, FL
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Oklahoma City, Oklahoma 73112
849
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Oklahoma City, OK
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Orlando, Florida 32806
797
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Orlando, FL
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Ormond Beach, Florida 32174
746
mi
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Ormond Beach, FL
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Paw Paw, Michigan 49079
215
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Paw Paw, MI
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Philadelphia, Pennsylvania 19104
416
mi
from 43215
Philadelphia, PA
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Philadelphia, Pennsylvania 19104
416
mi
from 43215
Philadelphia, PA
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Phoenix, Arizona 85006
1661
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Phoenix, AZ
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Phoenix, Arizona 85006
1661
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Phoenix, AZ
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Pittsburgh, Pennsylvania 15213
163
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from 43215
Pittsburgh, PA
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Port Charlotte, Florida 33952
898
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Port Charlotte, FL
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Port Royal, South Carolina 29935
539
mi
from 43215
Port Royal, SC
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Portland, Oregon 97225
2026
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from 43215
Portland, OR
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Richmond, Virginia 23230
340
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from 43215
Richmond, VA
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Rochester, New York 14623
352
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from 43215
Rochester, NY
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Rochester, New York 14623
352
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Rochester, NY
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Santa Ana, California 92701
2020
mi
from 43215
Santa Ana, CA
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Sarasota, Florida 34243
868
mi
from 43215
Sarasota, FL
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Savannah, Georgia 31419
562
mi
from 43215
Savannah, GA
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Springfield, Illinois 62702
349
mi
from 43215
Springfield, IL
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St. Paul, Minnesota 55130
617
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St. Paul, MN
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Stratford, New Jersey 08084
424
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Stratford, NJ
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Sunrise, Florida 33351
966
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Sunrise, FL
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Washington, District of Columbia 20057
325
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Washington,
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Wilmington, North Carolina 28401
485
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from 43215
Wilmington, NC
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Winchester, Massachusetts 01890
640
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from 43215
Winchester, MA
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Winston-Salem, North Carolina 27103
307
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Winston-Salem, NC
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