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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Elan Pharmaceuticals
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Elan Pharmaceuticals ( Elan Pharma International Limited )
ClinicalTrials.gov Identifier:
NCT01735630
First received: November 25, 2012
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
Drug: ELND005
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Elan Pharmaceuticals:

Primary Outcome Measures:
  • Change from Baseline in NPI-C combined agitation and aggression subscores [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in modified-ADCS-CGIC agitation scores [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in NPI total scores [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in MMSE scores [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in ADCS-ADL scores [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Incidence and severity of adverse events [ Time Frame: over 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: November 2012
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ELND005
ELND005 film coated tablets, BID for 12 weeks
Drug: ELND005
Other Name: Scyllo-inositol
Placebo Comparator: Placebo
Matched placebo BID for 12 weeks
Drug: Placebo

  Eligibility

Ages Eligible for Study:   50 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735630

Contacts
Contact: US and Canada: Call Center 1-866 395 2121
Contact: Europe: Lisa Parsons +1 503-475-0631

  Hide Study Locations
Locations
United States, Alabama
Elan Investigational Site Recruiting
Birmingham, Alabama, United States, 35294
United States, Arizona
Elan Investigational Site Recruiting
Phoenix, Arizona, United States, 85004
Elan Investigational Site Recruiting
Phoenix, Arizona, United States, 85006
United States, California
Elan Investigational Site Recruiting
Encino, California, United States, 91316
Elan Investigational Site Recruiting
Escondido, California, United States, 92025
Elan Investigational Site Recruiting
Fresno, California, United States, 93710
Elan Investigational Site Recruiting
Irvine, California, United States, 92697
Elan Investigational Site Recruiting
Long Beach, California, United States, 90806
Elan Investigational Site Recruiting
Los Alamitos, California, United States, 90720
Elan Investigational Site Recruiting
Los Angeles, California, United States, 90073
Elan Investigational Site Recruiting
Newport Beach, California, United States, 92663
Elan Investigational Site Recruiting
Santa Ana, California, United States, 92701
United States, Connecticut
Elan Investigational Site Recruiting
Norwalk, Connecticut, United States, 06851
United States, District of Columbia
Elan Investigational Site Recruiting
Washington, District of Columbia, United States, 20057
United States, Florida
Elan Investigational Site Recruiting
Atlantis, Florida, United States, 33462
Elan Investigational Site Recruiting
Deerfield Beach, Florida, United States, 33064
Elan Investigational Site Recruiting
Delray Beach, Florida, United States, 33445
Elan Investigational Site Recruiting
Lake Worth, Florida, United States, 33449
Elan Investigational Site Recruiting
Miami, Florida, United States, 33137
Elan Investigational Site Recruiting
Oakland Park, Florida, United States, 33334
Elan Investigational Site Recruiting
Orlando, Florida, United States, 32806
Elan Investigational Site Recruiting
Ormond Beach, Florida, United States, 32174
Elan Investigational Site Recruiting
Port Charlotte, Florida, United States, 33952
Elan Investigational Site Recruiting
Sarasota, Florida, United States, 34243
Elan Investigational Site Recruiting
Sunrise, Florida, United States, 33351
United States, Georgia
Elan Investigational Site Recruiting
Columbus, Georgia, United States, 31909
Elan Investigational Site Recruiting
Savannah, Georgia, United States, 31419
United States, Illinois
Elan Investigational Site Recruiting
Springfield, Illinois, United States, 62702
United States, Maine
Elan Investigational Site Recruiting
Bangor, Maine, United States, 04402
United States, Maryland
Elan Investigational Site Recruiting
Easton, Maryland, United States, 21601
United States, Massachusetts
Elan Investigational Site Recruiting
Winchester, Massachusetts, United States, 01890
United States, Michigan
Elan Investigational Site Recruiting
Ann Arbor, Michigan, United States, 48105
Elan Investigational Site Recruiting
Paw Paw, Michigan, United States, 49079
United States, Minnesota
Elan Investigational Site Recruiting
St. Paul, Minnesota, United States, 55130
United States, Mississippi
Elan Investigational Site Recruiting
Hattiesburg, Mississippi, United States, 39401
United States, New Jersey
Elan Investigational Site Recruiting
Stratford, New Jersey, United States, 08084
United States, New York
Elan Investigational Site Recruiting
Rochester, New York, United States, 14623
Elan Investigational Site Recruiting
Rochester, New York, United States, 14620
United States, North Carolina
Elan Investigational Site Recruiting
Charlotte, North Carolina, United States, 28209
Elan Investigational Site Recruiting
Charlotte, North Carolina, United States, 28211
Elan Investigational Site Recruiting
Durham, North Carolina, United States, 27710
Elan Investigational Site Recruiting
Wilmington, North Carolina, United States, 28401
Elan Investigational Site Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Oklahoma
Elan Investigational Site Recruiting
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Elan Investigational Site Recruiting
Portland, Oregon, United States, 97225
United States, Pennsylvania
Elan Investigational Site Recruiting
Abington, Pennsylvania, United States, 19001
Elan Investigational Site Recruiting
Jenkintown, Pennsylvania, United States, 19046
Elan Investigational Site Recruiting
Norristown, Pennsylvania, United States, 19401
Elan Investigational Site Recruiting
Philadelphia, Pennsylvania, United States, 19104
Elan Investigational Site Recruiting
Philadelphia, Pennsylvania, United States, 19107
Elan Investigational Site Recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Elan Investigational Site Recruiting
North Charleston, South Carolina, United States, 29406
Elan Investigational Site Recruiting
Port Royal, South Carolina, United States, 29935
United States, Tennessee
Elan Investigational Site Recruiting
Nashville, Tennessee, United States, 37212
United States, Texas
Elan Investigational Site Recruiting
DeSoto, Texas, United States, 75115
United States, Virginia
Elan Investigational Site Recruiting
Richmond, Virginia, United States, 23230
United States, Washington
Elan Investigational Site Recruiting
Bellevue, Washington, United States, 98007
Canada, Alberta
Elan Investigational Site Recruiting
Calgary, Alberta, Canada, T2N-4Z6
Canada, British Columbia
Elan Investigational Site Recruiting
Kelowna, British Columbia, Canada, V1Y 3G8
Canada, Ontario
Elan Investigational Site Recruiting
Toronto, Ontario, Canada, M6M 3Z5
Elan Investigational Site Recruiting
Toronto, Ontario, Canada, M4N 3M5
Canada, Saskatchewan
Elan Investigational Site Recruiting
Regina, Saskatchewan, Canada, S4T 1A5
Spain
Elan Investigational Site Recruiting
Elche, Alicante, Spain, 03203
Elan Investigational Site Recruiting
Getxo, Biscay, Spain, 48993
Elan Investigational Site Recruiting
Barcelona, Spain, 08029
Elan Investigational Site Recruiting
Barcelona, Spain, 08221
Elan Investigational Site Recruiting
Burgos, Spain, 09006
Elan Investigational Site Recruiting
Madrid, Spain, 28040
United Kingdom
Elan Investigational Site Recruiting
Bath, United Kingdom, BA1 3NG
Elan Investigational Site Recruiting
Swindon, United Kingdom, SN3 6BW
Sponsors and Collaborators
Elan Pharma International Limited
Elan Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Elan Pharmaceuticals ( Elan Pharma International Limited )
ClinicalTrials.gov Identifier: NCT01735630     History of Changes
Other Study ID Numbers: ELND005-AG201, 2012-004299-20
Study First Received: November 25, 2012
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Elan Pharmaceuticals:
Agitation
Aggression
patients

Additional relevant MeSH terms:
Alzheimer Disease
Psychomotor Agitation
Aggression
Behavioral Symptoms
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014