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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 n/a

TransitionTIL Investigational Site
Phoenix Arizona 85004 n/a

TransitionTIL Investigational Site
Phoenix Arizona 85006 n/a

TransitionTIL Investigational Site
Encino California 91316 n/a

TransitionTIL Investigational Site
Escondido California 92025 n/a

TransitionTIL Investigational Site
Fresno California 93710 n/a

TransitionTIL Investigational Site
Irvine California 92697 n/a

TransitionTIL Investigational Site
Long Beach California 90806 n/a

TransitionTIL Investigational Site
Los Alamitos California 90720 n/a

TransitionTIL Investigational Site
Los Angeles California 90073 n/a

TransitionTIL Investigational Site
Newport Beach California 92663 n/a

TransitionTIL Investigational Site
Santa Ana California 92701 n/a

TransitionTIL Investigational Site
Norwalk Connecticut 06851 n/a

TransitionTIL Investigational Site
Washington District of Columbia 20057 n/a

TransitionTIL Investigational Site
Atlantis Florida 33462 n/a

TransitionTIL Investigational Site
Deerfield Beach Florida 33064 n/a

TransitionTIL Investigational Site
Delray Beach Florida 33445 n/a

TransitionTIL Investigational Site
Lake Worth Florida 33449 n/a

TransitionTIL Investigational Site
Miami Florida 33137 n/a

TransitionTIL Investigational Site
Oakland Park Florida 33334 n/a

TransitionTIL Investigational Site
Orlando Florida 32806 n/a

TransitionTIL Investigational Site
Ormond Beach Florida 32174 n/a

TransitionTIL Investigational Site
Port Charlotte Florida 33952 n/a

TransitionTIL Investigational Site
Sarasota Florida 34243 n/a

TransitionTIL Investigational Site
Sunrise Florida 33351 n/a

TransitionTIL Investigational Site
Columbus Georgia 31909 n/a

TransitionTIL Investigational Site
Savannah Georgia 31419 n/a

TransitionTIL Investigational Site
Springfield Illinois 62702 n/a

TransitionTIL Investigational Site
Bangor Maine 04402 n/a

TransitionTIL Investigational Site
Easton Maryland 21601 n/a

TransitionTIL Investigational Site
Winchester Massachusetts 01890 n/a

TransitionTIL Investigational Site
Ann Arbor Michigan 48105 n/a

TransitionTIL Investigational Site
Paw Paw Michigan 49079 n/a

TransitionTIL Investigational Site
St. Paul Minnesota 55130 n/a

TransitionTIL Investigational Site
Hattiesburg Mississippi 39401 n/a

TransitionTIL Investigational Site
Stratford New Jersey 08084 n/a

TransitionTIL Investigational Site
Rochester New York 14620 n/a

TransitionTIL Investigational Site
Rochester New York 14623 n/a

TransitionTIL Investigational Site
Charlotte North Carolina 28209 n/a

TransitionTIL Investigational Site
Charlotte North Carolina 28211 n/a

TransitionTIL Investigational Site
Durham North Carolina 27710 n/a

TransitionTIL Investigational Site
Wilmington North Carolina 28401 n/a

TransitionTIL Investigational Site
Winston-Salem North Carolina 27103 n/a

TransitionTIL Investigational Site
Oklahoma City Oklahoma 73112 n/a

TransitionTIL Investigational Site
Portland Oregon 97225 n/a

TransitionTIL Investigational Site
Abington Pennsylvania 19001 n/a

TransitionTIL Investigational Site
Jenkintown Pennsylvania 19046 n/a

TransitionTIL Investigational Site
Norristown Pennsylvania 19401 n/a

TransitionTIL Investigational Site
Philadelphia Pennsylvania 19104 n/a

TransitionTIL Investigational Site
Philadelphia Pennsylvania 19107 n/a

TransitionTIL Investigational Site
Pittsburgh Pennsylvania 15213 n/a

TransitionTIL Investigational Site
North Charleston South Carolina 29406 n/a

TransitionTIL Investigational Site
Port Royal South Carolina 29935 n/a

TransitionTIL Investigational Site
Nashville Tennessee 37212 n/a

TransitionTIL Investigational Site
DeSoto Texas 75115 n/a

TransitionTIL Investigational Site
Richmond Virginia 23230 n/a

TransitionTIL Investigational Site
Bellevue Washington 98007 n/a

TransitionTIL Investigational Site
Calgary Alberta T2N-4Z6 n/a

TransitionTIL Investigational Site
Kelowna British Columbia V1Y 3G8 n/a

TransitionTIL Investigational Site
Toronto Ontario M4N 3M5 n/a

TransitionTIL Investigational Site
Toronto Ontario M6M 3Z5 n/a

TransitionTIL Investigational Site
Regina Saskatchewan S4T 1A5 n/a

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