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ELND005 for Agitation and Aggression in Alzheimer's Disease

Completed

The purpose of this study is to determine whether the experimental drug ELND005 is effective in treating symptoms of agitation and aggression in people with Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 95 Years Both No
November 2012
May 2015
400

  • Diagnosis of probable Alzheimer's disease (MMSE score of 5 to 24 inclusive at screening)
  • Clinically significant agitation/aggression, defined as Neuropsychiatric Inventory (NPI) agitation/aggression subscore of ≥4, with a severity score of ≥2 at both screening and baseline visits
  • No response or suboptimal response to standard nonpharmacological interventions

  • Agitation/aggression attributable to medications, environmental conditions, or an active medical or psychiatric condition
  • Current diagnosis of major depressive disorder
  • Symptoms of psychosis (delusion or hallucinations) that require treatment with antipsychotics or psychiatric hospitalization
  • Treated with oral antipsychotic medications within 2 weeks prior to screening; treated with depot preparations of an antipsychotic within 3 months prior to screening
  • MRI scan abnormalities at screening that can be attributed to diseases or processes other than Alzheimer's disease

The experimental drug being tested in this Phase II study, ELDN005, is a small molecule that has been found to block the accumulation of beta-amyloid oligomers and possibly protect against cognitive decline. Known generically as scyllo-inositol, it is a naturally occurring plant sugar alcohol found in the coconut palm, oak bark, and other plants.

For more information about this trial or its study sites, please contact the Elan Call Center at 1-866-395-2121.

Name City State Zip Status Primary Contact
TransitionTIL Investigational Site
Birmingham Alabama 35294

TransitionTIL Investigational Site
Phoenix Arizona 85004

TransitionTIL Investigational Site
Phoenix Arizona 85006

TransitionTIL Investigational Site
Encino California 91316

TransitionTIL Investigational Site
Escondido California 92025

TransitionTIL Investigational Site
Fresno California 93710

TransitionTIL Investigational Site
Irvine California 92697

TransitionTIL Investigational Site
Long Beach California 90806

TransitionTIL Investigational Site
Los Alamitos California 90720

TransitionTIL Investigational Site
Los Angeles California 90073

TransitionTIL Investigational Site
Newport Beach California 92663

TransitionTIL Investigational Site
Santa Ana California 92701

TransitionTIL Investigational Site
Norwalk Connecticut 06851

TransitionTIL Investigational Site
Washington District of Columbia 20057

TransitionTIL Investigational Site
Atlantis Florida 33462

TransitionTIL Investigational Site
Deerfield Beach Florida 33064

TransitionTIL Investigational Site
Delray Beach Florida 33445

TransitionTIL Investigational Site
Lake Worth Florida 33449

TransitionTIL Investigational Site
Miami Florida 33137

TransitionTIL Investigational Site
Oakland Park Florida 33334

TransitionTIL Investigational Site
Orlando Florida 32806

TransitionTIL Investigational Site
Ormond Beach Florida 32174

TransitionTIL Investigational Site
Port Charlotte Florida 33952

TransitionTIL Investigational Site
Sarasota Florida 34243

TransitionTIL Investigational Site
Sunrise Florida 33351

TransitionTIL Investigational Site
Columbus Georgia 31909

TransitionTIL Investigational Site
Savannah Georgia 31419

TransitionTIL Investigational Site
Springfield Illinois 62702

TransitionTIL Investigational Site
Bangor Maine 04402

TransitionTIL Investigational Site
Easton Maryland 21601

TransitionTIL Investigational Site
Winchester Massachusetts 01890

TransitionTIL Investigational Site
Ann Arbor Michigan 48105

TransitionTIL Investigational Site
Paw Paw Michigan 49079

TransitionTIL Investigational Site
St. Paul Minnesota 55130

TransitionTIL Investigational Site
Hattiesburg Mississippi 39401

TransitionTIL Investigational Site
Stratford New Jersey 08084

TransitionTIL Investigational Site
Rochester New York 14620

TransitionTIL Investigational Site
Rochester New York 14623

TransitionTIL Investigational Site
Charlotte North Carolina 28209

TransitionTIL Investigational Site
Charlotte North Carolina 28211

TransitionTIL Investigational Site
Durham North Carolina 27710

TransitionTIL Investigational Site
Wilmington North Carolina 28401

TransitionTIL Investigational Site
Winston-Salem North Carolina 27103

TransitionTIL Investigational Site
Oklahoma City Oklahoma 73112

TransitionTIL Investigational Site
Portland Oregon 97225

TransitionTIL Investigational Site
Abington Pennsylvania 19001

TransitionTIL Investigational Site
Jenkintown Pennsylvania 19046

TransitionTIL Investigational Site
Norristown Pennsylvania 19401

TransitionTIL Investigational Site
Philadelphia Pennsylvania 19104

TransitionTIL Investigational Site
Philadelphia Pennsylvania 19107

TransitionTIL Investigational Site
Pittsburgh Pennsylvania 15213

TransitionTIL Investigational Site
North Charleston South Carolina 29406

TransitionTIL Investigational Site
Port Royal South Carolina 29935

TransitionTIL Investigational Site
Nashville Tennessee 37212

TransitionTIL Investigational Site
DeSoto Texas 75115

TransitionTIL Investigational Site
Richmond Virginia 23230

TransitionTIL Investigational Site
Bellevue Washington 98007

TransitionTIL Investigational Site
Calgary Alberta T2N-4Z6

TransitionTIL Investigational Site
Kelowna British Columbia V1Y 3G8

TransitionTIL Investigational Site
Toronto Ontario M4N 3M5

TransitionTIL Investigational Site
Toronto Ontario M6M 3Z5

TransitionTIL Investigational Site
Regina Saskatchewan S4T 1A5

Elan Pharmaceuticals

  • Elan Pharmaceuticals

Name Phone Email
Elan Call Center 1-866-395-2121

NCT01735630

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