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

This study has been completed.
Elan Pharmaceuticals
Information provided by (Responsible Party):
Transition Therapeutics Ireland Limited Identifier:
First received: November 25, 2012
Last updated: July 8, 2015
Last verified: July 2015
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 Transition Therapeutics Ireland Limited:

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 ]

Enrollment: 350
Study Start Date: November 2012
Study Completion Date: May 2015
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


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

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 identifier: NCT01735630

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Sponsors and Collaborators
Transition Therapeutics Ireland Limited
Elan Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Transition Therapeutics Ireland Limited Identifier: NCT01735630     History of Changes
Other Study ID Numbers: ELND005-AG201  2012-004299-20 
Study First Received: November 25, 2012
Last Updated: July 8, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Transition Therapeutics Ireland Limited:

Additional relevant MeSH terms:
Alzheimer Disease
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Nervous System Diseases
Neurocognitive Disorders
Neurodegenerative Diseases
Tauopathies processed this record on May 26, 2016